Peter Richmond

The STAMP RSV Program

STAMP-RSV is guided by a community reference group with lived experiences of RSV. The goal is to translate research findings into effective and efficient RSV control policies to reduce the health and economic burden of RSV.

Healthy Ears Clinical Trial: A telehealth-facilitated randomised-controlled trial utilising a health promotion intervention to resolve otitis media with effusion for children won specialist Ear, Nose and Throat (ENT) waiting lists

A telehealth-facilitated randomised-controlled trial utilising a health promotion intervention to resolve otitis media with effusion for children won specialist Ear, Nose and Throat (ENT) waiting lists

Djaalinj Waakinj Ear Portal: An ENT and Audiology referral pathway for improving access to ear and hearing services for Aboriginal children in the metropolitan area using telehealth

The Djaalinj Waakinj (Listening, Talking) Ear Portal project commenced in 2020 to evaluate an equitable ear and hearing care pathway for Aboriginal children residing in the metropolitan area of Perth.

WA Aboriginal Child Health Survey (WAACHS) Data Linkage Study

This study is a partnership between researchers, the Aboriginal community and government to provide evidence for policy and practice addressing high priority health and wellbeing issues for Aboriginal children and families.

Kids Easy Breathing Study

As both bronchiolitis and bronchiectasis are diseases of the airway surface, we will comprehensively study the airway surface and factors affecting the airway surface in infants hospitalised with bronchiolitis.

Preparing for prevention: Assessing the community awareness of RSV and other childhood infections

Respiratory Syncytial Virus (RSV) is one of the most common reasons babies are admitted to hospital – with Aboriginal and preterm infants at greatest risk.

Characterising the epidemiology of RSV in Australian children through record linkage: clinical burden, outcomes and risk factors

PATRIC: Pragmatic Adaptive Trial for Respiratory Infections in Children

Impact of Repeat Pertussis Vaccination on Infant and Maternal Antibody Quality

Unlocking the immunology of whooping cough vaccines to guide the development of improved vaccines and schedules in Australia

Pathogens on the rise: is impaired immunity the cause of chronic ear and chest infections?

A systems biology approach to determining the risk for development of otitis media

Does mum know best? Should we be vaccinating mothers to protect their babies from ear and lung disease?

Defining the cellular immune response to vaccines for enhanced protection from invasive pneumococcal disease

Community immunity: Developing a sensitive and specific SARS-CoV-2 antibody test

A Phase 3, Randomized, Observer-Blind, Placebo-Controlled, Group-Sequential Study to Determine the Immunogenicity and Safety of a Respiratory Syncytial Virus (RSV) F Nanoparticle Vaccine with Aluminium in Healthy Third-trimester Pregnant Women; and Safety

Sore Throat Melbourne and Perth Study: The Australian Strep A Vaccine Initiative (ASAVI) Urban Pharyngitis Surveillance Study (STAMPS)

COVALIA (COVid vaccine trial for austrALIA): A phase I, double-blind, dose-ranging, randomised, placebo-controlled trial to study the safety and immunogenicity of a DNA-based vaccine against COVID-19 (COVIGEN) in healthy participants aged 18 to 75 years o

A phase 3, randomized, double-blinded, placebo-controlled trial toevaluate the efficacy and safety of a respiratory syncytial virus (RSV) prefusion F subunit vaccine in infants born to women vaccinated during pregnancy (Matisse)

Safety and Immunogenicity of Early Quadrivalent Influenza Vaccine: A phase 2prospective randomised open-label feasibility study (FluBub)

A Phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine given as a series of 2 infant doses and 1 toddler dose in healthy infants (NeXXstep)

A Phase I/II, Multicentre, Observer-blinded, Randomized, Active Controlled, Clinical Trial to Assess the Reactogenicity, Safety and Immunogenicity of a combined Tetanus, Diphtheria, Acellular Pertussis and Poliomyelitis Vaccine (SIIPL Tdap-IPV) in Compari

A Phase III, randomized, controlled, observer-blind study to demonstrate effectiveness, immunogenicity and safety of GSK's meningococcal Group B and combined ABCWY vaccines when administered to healthy adolescents and young adults (Quintet)

Pneumo-BNA: Using Bayesian network models to facilitate a microbiological diagnosis in childhood pneumonia: development of a clinical decision support tool

Influenza vaccination in Western Australian children: an economic evaluation to inform future state and national programs

Childhood pneumonia in the Eastern Highlands Province of Papua New Guinea: clinical, microbiological and immunological predictors of disease

Testing the meningococcal conjugate vaccine MenACWY-TT in toddlers

Study of an oral medication for infants hospitalized with Respiratory Syncytial Virus (RSV) infection

PneumoWA: A case-control study of the role of viral and bacterial pathogens in causing pneumonia among Western Australian children

Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

Efficacy, Immunogenicity, and Safety Study of Clostridium difficile Toxoid Vaccine in Subjects at Risk for C. difficile Infection

Duration of Pertussis Immunity in Adults: A Study of Health Care Workers

AusVaxSafety

A study to determine the safety and immunogenicity of 10-valent and 13-valent pneumococcal conjugate vaccines in Papua New Guinean children

A Phase II Randomized, Controlled, Observer-Blinded Study, Conducted to Describe the Immunogenicity, Safety, and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine When Administered to Healthy Toddlers

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

The Long-term Impact of Serogroup B Invasive Meningococcal Disease (IMD) in Australian Adolescents and Young Adults: AMEND study

Protective Vaccine Responses in Infants after Maternal Pertussis Vaccination (PRIME) Study

Pertaprime: An investigator-driven phase II-III randomised, observer-blind, controlled trial to demonstrate non-inferior immunogenicity of Pertagen® in comparison to Boostrix® in healthy young Australian adults aged 18-25 years

BCG vaccination to Reduce the impact of COVID-19 in Australian healthcare workers following Coronavirus Exposure (BRACE) Trial

ATOMIC Ears: A Phase IIB randomised controlled trial to assess safety, tolerability and acceptability of a 5-day Dornase alfa treatment as an adjunct therapy to ventilation tube insertion for otitis media in children

A randomized, controlled, observer-blind, phase 1/2a study to evaluate the safety, reactogenicity, and immunogenicity of Ad26.RSV.preF in RSV-seronegative toddlers 12 to 24 months of age

A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants (PNEU-PED-EU-1)

A phase 3, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety and tolerability of V114 in healthy infants (PNEULINK)

ADAPTS: Antibiotic Dysbiosis And Probiotics Trial in infantS

Down Syndrome Clinical Trial- BTD-001

PIFA - Pertussis and Food allergy, a case-cohort study of the association between pertussis vaccination in infancy and the risk of IgE-mediated food allergy

OPTIMUM: OPTimising IMmunisation Using Mixed schedules

Koorlungkas yarning: Exploring the impact of OM on early language and communication skills in urban Aboriginal families

Kadadjiny Dwank (listening, thinking and learning with your ears), Otitis Media from an urban Aboriginal perspective

Djaalinj Waakinj: A cohort study of otitis media in young urban Aboriginal children – prevalence, risk factors and consequences

Ear Portal: An ENT and Audiology referral portal for improving access to ear health services for children using telehealth

Cochrane CSOM: A suite of reviews examining the effectiveness of interventions to treat chronic suppurative otitis media (CSOM) globally

Pathogenesis of obstructive sleep apnoea

Microbiological and immunological factors predicting surgical outcomes for chronic otitis media

Immunogenicity of pneumococcal vaccine schedules in high-risk infants in Papua New Guinea

Evaluation of a bacterial therapy for prevention of respiratory infection including influenza and otitis media

Dornase alfa as an adjunct therapy to treat chronic ear infections

Development of molecular tools for accurate diagnosis and disease surveillance (including vaccine impact)

Paediatric Active Enhanced Diseases Surveillance (PAEDS)

PAEDS monitors for key vaccine preventable conditions and severe side effects from vaccine in 5 paediatric hospitals in Australia.

The Platform trial In COVID-19 vaccine priming and BOOsting (PICOBOO) booster vaccination substudy protocol

Coronavirus-2019 (COVID-19) vaccination in Australia commenced in February 2021. The first vaccines recommended for use were AZD1222 and BNT162b2, both delivered as a two-dose primary schedule. In the absence of sustained immunity following immunisation, recommendations for booster vaccination have followed. It is likely that periodic boosting will be necessary for at least some Australians, but it is unknown what the optimal booster vaccines and schedules are or for whom vaccination should be recommended. 

The Platform Trial In COVID-19 Priming and BOOsting (PICOBOO): The immunogenicity, reactogenicity, and safety of different COVID-19 vaccinations administered as a second booster

PICOBOO is a randomised, adaptive trial evaluating the immunogenicity, reactogenicity, and safety of COVID-19 booster strategies. We report data for second boosters among individuals 50-<70 years old primed with AZD1222 (50-<70y-AZD1222) until Day 84.

Plasma adenosine deaminase-1 and -2 activities are lower at birth in Papua New Guinea than in The Gambia but converge over the first weeks of life

Dynamic cellular and molecular adaptations in early life significantly impact health and disease. Upon birth, newborns are immediately challenged by their environment, placing urgent demands on the infant immune system. 

Cohort profile: The WAACHS Linked Data Study

Despite the volume of accumulating knowledge from prospective Aboriginal cohort studies, longitudinal data describing developmental trajectories in health and well-being is limited.

DNA Methylation signatures underpinning blood neutrophil to lymphocyte ratio during first week of human life

Understanding of newborn immune ontogeny in the first week of life will enable age-appropriate strategies for safeguarding vulnerable newborns against infectious diseases. Here we conducted an observational study exploring the immunological profile of infants longitudinally throughout their first week of life. 

Antecedent and persistent symptoms in COVID-19 and other respiratory illnesses: Insights from prospectively collected data in the BRACE trial

Some individuals have a persistence of symptoms following both COVID-19 (post-acute COVID-19 syndrome; PACS) and other viral infections. This study used prospectively collected data from an international trial to compare symptoms following COVID-19 and non-COVID-19 respiratory illness, to identify factors associated with the risk of PACS, and to explore symptom patterns before and after COVID-19 and non-COVID-19 respiratory illnesses.

The seroprevalence of SARS-CoV-2-specific antibodies in Australian children: A crosssectional study

Following reduction of public health and social measures concurrent with SARS-CoV-2 Omicron emergence in late 2021 in Australia, COVID-19 case notification rates rose rapidly. As rates of direct viral testing and reporting dropped, true infection rates were most likely to be underestimated.

Respiratory Viral Testing Rate Patterns in Young Children Attending Tertiary Care Across Western Australia: A Population-Based Birth Cohort Study

Phase 1 trial of an investigational Tdap booster vaccine with CpG 1018 adjuvant compared with Boostrix in healthy adults and adolescents

This phase 1 trial assessed the safety and immunogenicity of an investigational tetanus/diphtheria/acellular pertussis vaccine combined with CpG 1018 adjuvant 1500 μg (Tdap-1018 1500 μg) or 3000 μg (Tdap-1018 3000 μg) in adults and adolescents.

A Phase 1/2a Study Evaluating Safety and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers Aged 12-24 Months

Respiratory syncytial virus (RSV) causes serious illness in children. The Ad26.RSV.preF vaccine candidate was immunogenic with acceptable safety in a phase 1/2a study of RSV-seropositive children. Here, we assessed its safety and immunogenicity in RSV-seronegative children. 

Nasal Delivery of Haemophilus haemolyticus Is Safe, Reduces Influenza Severity, and Prevents Development of Otitis Media in Mice

Despite vaccination, influenza and otitis media (OM) remain leading causes of illness. We previously found that the human respiratory commensal Haemophilus haemolyticus prevents bacterial infection in vitro and that the related murine commensal Muribacter muris delays OM development in mice. The observation that M muris pretreatment reduced lung influenza titer and inflammation suggests that these bacteria could be exploited for protection against influenza/OM.

Breastfeeding and Neonatal Age Influence Neutrophil-Driven Ontogeny of Blood Cell Populations in the First Week of Human Life

The first few days of life are characterized by rapid external and internal changes that require substantial immune system adaptations. Despite growing evidence of the impact of this period on lifelong immune health, this period remains largely uncharted. 

Statistical considerations for the platform trial in COVID-19 vaccine priming and boosting

The Platform trial In COVID-19 priming and BOOsting (PICOBOO) is a multi-site, adaptive platform trial designed to generate evidence of the immunogenicity, reactogenicity, and cross-protection of different booster vaccination strategies against severe acute respiratory syndrome coronavirus 2 and its variants, specific for the Australian context.

Immunogenicity, reactogenicity, and IgE-mediated immune responses of a mixed whole-cell and acellular pertussis vaccine schedule in Australian infants: A randomised, double-blind, noninferiority trial

In many countries, infant vaccination with acellular pertussis (aP) vaccines has replaced use of more reactogenic whole-cell pertussis (wP) vaccines. Based on immunological and epidemiological evidence, we hypothesised that substituting the first aP dose in the routine vaccination schedule with wP vaccine might protect against IgE-mediated food allergy. We aimed to compare reactogenicity, immunogenicity, and IgE-mediated responses of a mixed wP/aP primary schedule versus the standard aP-only schedule.

Bacille Calmette-Guérin vaccination to prevent febrile and respiratory illness in adults (BRACE): secondary outcomes of a randomised controlled phase 3 trial

Bacille Calmette-Guérin (BCG) vaccination has off-target (non-specific) effects that are associated with protection against unrelated infections and decreased all-cause mortality in infants. We aimed to determine whether BCG vaccination prevents febrile and respiratory infections in adults.

Cohort profile: A population-based record linkage platform to address critical epidemiological evidence gaps in respiratory syncytial virus and other respiratory infections

The Western Australia (WA) Respiratory Infections Linked Data Platform is a population-based cohort established to investigate the epidemiology of RSV and other respiratory infections in children aged 0-10 years, incorporating microbiological testing patterns, hospital admissions, emergency department presentations, and socio-demographic data.

An infant mouse model of influenza-driven nontypeable Haemophilus influenzae colonization and acute otitis media suitable for preclinical testing of novel therapies

Nontypeable Haemophilus influenzae (NTHi) is a major otitis media (OM) pathogen, with colonization a prerequisite for disease development. Most acute OM is in children <5 years old, with recurrent and chronic OM impacting hearing and learning. Therapies to prevent NTHi colonization and/or disease are needed, especially for young children. Respiratory viruses are implicated in driving the development of bacterial OM in children.

Randomized Trial of BCG Vaccine to Protect against Covid-19 in Health Care Workers

The bacille Calmette-Guérin (BCG) vaccine has immunomodulatory "off-target" effects that have been hypothesized to protect against coronavirus disease 2019. 

Nirsevimab binding-site conservation in respiratory syncytial virus fusion glycoprotein worldwide between 1956 and 2021: an analysis of observational study sequencing data

Nirsevimab is an extended half-life monoclonal antibody to the respiratory syncytial virus (RSV) fusion protein that has been developed to protect infants for an entire RSV season. Previous studies have shown that the nirsevimab binding site is highly conserved. However, investigations of the geotemporal evolution of potential escape variants in recent (ie, 2015–2021) RSV seasons have been minimal.

A phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of a 4-dose regimen of V114, a 15-valent pneumococcal conjugate vaccine, in healthy infants (PNEU-PED)

Pneumococcal disease (PD) remains a major health concern with considerable morbidity and mortality in children. Currently licensed pneumococcal conjugate vaccines (PCVs) confer protection against PD caused by most vaccine serotypes, but non-vaccine serotypes contribute to residual disease. V114 is a 15-valent PCV containing all 13 serotypes in Prevnar 13™ (PCV13) and additional serotypes 22F and 33F. This pivotal phase 3 study compared safety and immunogenicity of V114 and PCV13. 

Clinical predictors of hypoxic pneumonia in children from the Eastern Highlands Province, Papua New Guinea: secondary analysis of two prospective observational studies

Pneumonia is the leading cause of death in young children globally and is prevalent in the Papua New Guinea highlands. We investigated clinical predictors of hypoxic pneumonia to inform local treatment guidelines in this resource-limited setting.

Safety and Tolerability of V114 Pneumococcal Vaccine in Infants: A Phase 3 Study

Disease caused by Streptococcus pneumoniae is associated with considerable morbidity and mortality in children. Pneumococcal conjugate vaccines are well tolerated and effective at reducing pneumococcal disease caused by vaccine serotypes. VAXNEUVANCE (V114) is a 15-valent PCV containing 13 serotypes in Prevnar 13, plus serotypes 22F and 33F. This large phase 3 study evaluated safety and tolerability of V114 in infants. 

Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants: A phase III study (PNEU-PED-EU-2)

This phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in healthy infants. V114 contains all 13 serotypes in PCV13 and additional serotypes 22F and 33F.

Parental awareness and attitudes towards prevention of respiratory syncytial virus in infants and young children in Australia

To assess parental awareness of respiratory syncytial virus (RSV) and the level of acceptance of future RSV prevention strategies. A cross-sectional online survey was implemented targeting "future" and "current" parents of children aged ≤5 years in Australia.

Infant Whole-Cell Versus Acellular Pertussis Vaccination in 1997 to 1999 and Risk of Childhood Hospitalization for Food-Induced Anaphylaxis: Linked Administrative Databases Cohort Study

Evidence suggests that children who had received an initial priming dose of whole-cell pertussis (wP) vaccine, rather than acellular pertussis (aP) vaccine, had a lower risk of developing IgE-mediated food allergy, the most common cause of anaphylaxis-related hospital presentations of childhood.

A hospital-based asynchronous ENT telehealth service for children with otitis media: Cost-minimisation and improved access

The purpose of this study is to explore the effectiveness of a hospital-based asynchronous ear, nose, and throat telehealth service (the Ear Portal) in reducing cost and improving access for children with otitis media.

Pragmatic Adaptive Trial for Respiratory Infection in Children (PATRIC) Clinical Registry protocol

Acute respiratory infections (ARI) are the most common cause of paediatric hospitalisation. There is an urgent need to address ongoing critical knowledge gaps in ARI management. The Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) Clinical Registry will evaluate current treatments and outcomes for ARI in a variety of paediatric patient groups.

Safety, tolerability, and effect of a single aural dose of Dornase alfa at the time of ventilation tube surgery for otitis media: A Phase 1b double randomized control trial

One third of children require repeat ventilation tube insertion (VTI) for otitis media. Disease recurrence is associated with persistent middle ear bacterial biofilms. With demonstration that Dornase alfa (a DNase) disrupts middle ear effusion biofilms ex vivo, we identified potential for this as an anti-biofilm therapy to prevent repeat VTI. First, safety and tolerability needed to be measured.

Global Prevalence of Varicella-Associated Complications: A Systematic Review and Meta-Analysis

Varicella (chickenpox) is an infectious disease caused by the varicella zoster virus affecting children, adolescents, and adults. Varicella symptoms are usually self-limiting; however, different complications with widespread and systemic manifestations can occur. This systematic literature review aims to explore and quantify varicella-associated complication rates.

Meningococcal Disease in the Post–COVID-19 Era: A Time to Prepare

The global invasive meningococcal disease (IMD) landscape changed considerably during the COVID-19 pandemic, as evidenced by decreased incidence rates due to COVID-19 mitigation measures, such as limited social contact, physical distancing, mask wearing, and hand washing. Vaccination rates were also lower during the pandemic relative to pre-pandemic levels.

Impact of ventilation tube insertion on long-term language outcomes at 6 and 10 years of age: A prospective pregnancy cohort study

Investigating the impact of early childhood ventilation tube insertion (VTI) on long-term language outcomes. 

Factors Predicting Secondary Respiratory Morbidity Following Early-Life Respiratory Syncytial Virus Infections: Population-Based Cohort Study

The association between early-life respiratory syncytial virus infections and later respiratory morbidity is well established. However, there is limited evidence on factors that influence this risk. We examined sociodemographic and perinatal factors associated with later childhood respiratory morbidity requiring secondary care following exposure to a laboratory-confirmed RSV episode in the first 2 years.

FeBRILe3: Safety Evaluation of Febrile Infant Guidelines Through Prospective Bayesian Monitoring

Despite evidence supporting earlier discharge of well-appearing febrile infants at low risk of serious bacterial infection (SBI), admissions for ≥48 hours remain common. Prospective safety monitoring may support broader guideline implementation.

Influenza vaccination in Western Australian children: Exploring the health benefits and cost savings of increased vaccine coverage in children

To assess potential benefits and direct healthcare cost savings with expansion of an existing childhood influenza immunisation program, we developed a dynamic transmission model for the state of Western Australia, evaluating increasing coverage in children < 5 years and routinely immunising school-aged children.

A Review of Cardiac Surgical Procedures and Their Outcomes for Paediatric Rheumatic Heart Disease in Western Australia

Surgical intervention is an important treatment modality for advanced rheumatic heart disease (RHD). This study aimed to describe patient characteristics and outcomes from cardiac surgery for RHD in patients referred to the only tertiary paediatric hospital in Western Australia. 

Association between pertussis vaccination in infancy and childhood asthma: A population-based record linkage cohort study

Asthma is among the commonest noncommunicable diseases of childhood and often occurs with other atopic comorbidities. A previous case-control study found evidence that compared to children who received acellular pertussis (aP) vaccines in early infancy, children who received one or more doses of whole-cell pertussis (wP) vaccine had lower risk of developing IgE-mediated food allergy. We hypothesized that wP vaccination in early infancy might protect against atopic asthma in childhood. 

Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial

Recurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects.

Determining the true incidence of seasonal respiratory syncytial virus-confirmed hospitalizations in preterm and term infants in Western Australia

Respiratory syncytial virus contributes to significant global infant morbidity and mortality. We applied a previously developed statistical prediction model incorporating pre-pandemic RSV testing data and hospital admission data to estimate infant RSV-hospitalizations by birth month and prematurity, focused on infants aged <1 year.

Pneumococcal carriage, serotype distribution, and antimicrobial susceptibility in Papua New Guinean children vaccinated with PCV10 or PCV13 in a head-to-head trial

Children in Papua New Guinea (PNG) are at high risk of pneumococcal infections. We investigated pneumococcal carriage rates, serotype distribution, and antimicrobial susceptibility in PNG children after vaccination with 10-valent or 13-valent pneumococcal conjugate vaccines (PCV10; PCV13).

Pneumococcal Conjugate Vaccines Are Protective Against Respiratory Syncytial Virus Hospitalizations in Infants: A Population-Based Observational Study

Pneumococcal conjugate vaccines (PCV) reduced the risk of respiratory syncytial virus (RSV) in a randomized clinical trial. We aimed to assess the real-world effectiveness of PCV on RSV-hospitalizations among Western Australian infants.

Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants

Whether vaccination during pregnancy could reduce the burden of respiratory syncytial virus (RSV)-associated lower respiratory tract illness in newborns and infants is uncertain.

A Phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V114 compared with PCV13 in healthy infants (PNEU-PED-EU-1)

V114 (15-valent pneumococcal conjugate vaccine [PCV]) contains all serotypes in 13-valent PCV (PCV13) and additional serotypes 22F and 33F. This study evaluated safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines.

Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)

The need for coronavirus 2019 (COVID-19) vaccination in different age groups and populations is a subject of great uncertainty and an ongoing global debate. Critical knowledge gaps regarding COVID-19 vaccination include the duration of protection offered by different priming and booster vaccination regimens in different populations, including homologous or heterologous schedules.

among children with pneumonia using a causal Bayesian network

Pneumonia remains a leading cause of hospitalization and death among young children worldwide, and the diagnostic challenge of differentiating bacterial from non-bacterial pneumonia is the main driver of antibiotic use for treating pneumonia in children. Causal Bayesian networks (BNs) serve as powerful tools for this problem as they provide clear maps of probabilistic relationships between variables and produce results in an explainable way by incorporating both domain expert knowledge and numerical data.

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study

Sickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD.

Ear Portal: An urban-based ear, nose, and throat, and audiology referral telehealth portal to improve access to specialist ear-health services for children

Shortage of ear, nose, and throat specialists in public hospitals can result in delays in the detection and management of otitis media. This study introduced a new hospital-based telehealth service, named the Ear Portal, and investigated its role in improving access to specialist care.

Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD: a V114-023 (PNEU-SICKLE) study

Sickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including an increased risk of invasive disease caused by encapsulated bacteria, such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to a significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in children with SCD.

Adverse event reports of anaphylaxis after Comirnaty and Vaxzevria COVID-19 vaccinations, Western Australia, 22 February to 30 June 2021

Within the first 4 months of the Western Australian COVID-19 immunisation programme, 49 suspected anaphylaxis cases were reported to the vaccine safety surveillance system. Twelve reports met Brighton Collaboration case definition, corresponding to rates of 15.9 and 17.7 per million doses of Vaxzevria and Comirnaty administered respectively.

Impact of previous exposure to SARS-CoV-2 and of S-Trimer (SCB-2019) COVID-19 vaccination on the risk of reinfection: a randomised, double-blinded, placebo-controlled, phase 2 and 3 trial

We previously reported the efficacy of the adjuvanted-protein COVID-19 vaccine candidate S-Trimer (SCB-2019) in adults who showed no evidence of previous exposure to SARS-CoV-2. In this study, we aimed to investigate the extent of protection afforded by previous exposure to SARS-CoV-2 on subsequent COVID-19 infection, as well as the efficacy, safety, and reactogenicity of SCB-2019 in participants who were enrolled in the Study.

Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape

Respiratory syncytial virus is the second most common cause of infant mortality and a major cause of morbidity and mortality in older adults (aged >60 years). Efforts to develop a respiratory syncytial virus vaccine or immunoprophylaxis remain highly active.

Off-target effects of bacillus Calmette-Guerin vaccination on immune responses to SARS-CoV-2: implications for protection against severe COVID-19

Because of its beneficial off-target effects against non-mycobacterial infectious diseases, bacillus Calmette-Guérin vaccination might be an accessible early intervention to boost protection against novel pathogens. Multiple epidemiological studies and randomised controlled trials are investigating the protective effect of BCG against coronavirus disease 2019 (COVID-19).

The seroprevalence of SARS-CoV-2-specific antibodies in children, Australia, November 2020 - March 2021

A phase III, multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of catch-up vaccination regimens of V114, a 15-valent pneumococcal conjugate vaccine(PNEU-PLAN)

Despite widespread use of pneumococcal conjugate vaccines (PCVs) in children, morbidity and mortality caused by pneumococcal disease (PD) remain high. In addition, many children do not complete their PCV course on schedule. V114 is a 15-valent PCV that contains two epidemiologically important serotypes, 22F and 33F, in addition to the 13 serotypes present in PCV13, the licensed 13-valent PCV.

Early onset of otitis media is a strong predictor of subsequent disease in urban Aboriginal infants: Djaalinj Waakinj cohort study

Australian Aboriginal and/or Torres Strait Islander children in rural/remote areas suffer high rates of persistent otitis media (OM) from early infancy. We aimed to determine the proportion of Aboriginal infants living in an urban area who have OM and investigate associated risk factors.

Estimating the excess burden of pertussis disease in Australia within the first year of life, that might have been prevented through timely vaccination

Previous Australian studies have shown that delayed vaccination with each of the three primary doses of diphtheria-tetanus-pertussis-containing vaccines (DTP) is up to 50 % in certain subpopulations. We estimated the excess burden of pertussis that might have been prevented if (i) all primary doses and (ii) each dose was given on time.

Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1–9 years: two phase 2 randomised, controlled, observer-blinded studies

The meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) is licensed for use in children aged 10 years or older for protection against invasive serogroup B meningococcal disease. Because young children are at increased risk of invasive meningococcal disease, MenB-FHbp clinical data in this population are needed.

Long-term follow-up after recurrent otitis media and ventilation tube insertion: Hearing outcomes and middle-ear health at six years of age

To investigate the long-term impact of recurrent otitis media (rOM) and ventilation tube insertion (VTI) in early childhood on hearing outcomes and middle-ear health three to five years later, in a prospective pregnancy cohort study.

Evidence of maternal transfer of antigen-specific antibodies in serum and breast milk to infants at high-risk of S. pneumoniae and H. influenzae disease

Children in low-mid income countries, and First Nations children in high-income countries, experience disproportionately high rates of Streptococcus pneumoniae and Haemophilus influenzae infections and diseases including pneumonia and otitis media.

Development of an International Database for a Rare Genetic Disorder: The MECP2 Duplication Database (MDBase)

The natural history of MECP2 duplication syndrome (MDS), a rare X-linked neurodevelopmental disorder with an estimated birth prevalence of 1/150,000 live births, is poorly understood due to a lack of clinical data collected for research. Such information is critical to the understanding of disease progression, therapeutic endpoints and outcome measures for clinical trials, as well as the development of therapies and orphan products.

Prevalence of respiratory viruses in community-acquired pneumonia in children: a systematic review and meta-analysis

Respiratory viruses are increasingly detected in children with community-acquired pneumonia but prevalence estimates vary substantially. We aimed to systematically review and pool estimates for 22 viruses commonly associated with community-acquired pneumonia.

The safety of co-administration of Bacille Calmette-Guérin (BCG) and influenza vaccines

With the emergence of novel vaccines and new applications for older vaccines, co-administration is increasingly likely. The immunomodulatory effects of BCG could theoretically alter the reactogenicity of co-administered vaccines. Using active surveillance in a randomised controlled trial, we aimed to determine whether co-administration of BCG vaccination changes the safety profile of influenza vaccination.

Severity of Rotavirus-Vaccine-Associated Intussusception: Prospective Hospital-Based Surveillance, Australia, 2007-2018

Multiple studies have shown an association between intussusception (IS) and receipt of monovalent or pentavalent rotavirus vaccine (RV) in the previous 21 days. Disease severity is an important consideration for risk-benefit evaluations of RV, but no studies have compared the severity of IS within 21 days of vaccination (vaccine-associated, VA) and later (not temporally-associated, VNA).

Medical Comorbidities in MECP2 Duplication Syndrome: Results from the International MECP2 Duplication Database

Since the discovery of MECP2 duplication syndrome (MDS) in 1999, efforts to characterise this disorder have been limited by a lack of large datasets, with small case series often favouring the reporting of certain conditions over others. This study is the largest to date, featuring 134 males and 20 females, ascertained from the international MECP2 Duplication Database (MDBase).

A Prospective Study Investigating the Impact of Obesity on the Immune Response to the Quadrivalent Influenza Vaccine in Children and Adolescents

Obesity can increase the severity of influenza infection. Data are limited regarding immune responses to influenza vaccination in obese children. We aimed to investigate the impact of obesity on quadrivalent influenza vaccine responses in children.

Australian Aboriginal Otitis-Prone Children Produce High-Quality Serum IgG to Putative Nontypeable Haemophilus influenzae Vaccine Antigens at Lower Titres Compared to Non-Aboriginal Children

Nontypeable Haemophilus influenzae (NTHi) is the most common bacterial otopathogen associated with otitis media (OM). NTHi persists in biofilms within the middle ears of children with chronic and recurrent OM. Australian Aboriginal children suffer exceptionally high rates of chronic and recurrent OM compared to non-Aboriginal children.

Sleep Disordered Breathing and Recurrent Tonsillitis Are Associated With Polymicrobial Bacterial Biofilm Infections Suggesting a Role for Anti-Biofilm Therapies

The underlying pathogenesis of pediatric obstructive sleep disordered breathing (SDB) and recurrent tonsillitis (RT) are poorly understood but need to be elucidated to develop less invasive treatment and prevention strategies.

A brief history of MECP2 duplication syndrome: 20-years of clinical understanding

MECP2 duplication syndrome (MDS) is a rare, X-linked, neurodevelopmental disorder caused by a duplication of the methyl-CpG-binding protein 2 (MECP2) gene-a gene in which loss-of-function mutations lead to Rett syndrome (RTT). MDS has an estimated live birth prevalence in males of 1/150,000.

4CMenB vaccine and its role in preventing transmission and inducing herd immunity

Vaccination is the most effective method of protecting people from invasive meningococcal disease (IMD). Of all the capsular groups, B is the most common cause of invasive meningococcal disease in many parts of the world. Despite this, adolescent meningococcal B vaccine programs have not been implemented globally, partly due to the lack of evidence for herd immunity afforded by meningococcal B vaccines.

Persistence of the immune responses and cross-neutralizing activity with Variants of Concern following two doses of adjuvanted SCB-2019 COVID-19 vaccine

We have previously reported the safety and immunogenicity four weeks after two doses of the Clover COVID-19 vaccine candidate, SCB-2019, a stabilized pre-fusion form of the SARS-CoV-2 S-protein (S-trimer). We now report persistence of antibodies up to 6 months after vaccination, and cross-neutralization titers against three Variants of Concern.

Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial

As part of the accelerated development of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), we report a dose-finding and adjuvant justification study of SCB-2019, a protein subunit vaccine candidate containing a stabilised trimeric form of the spike (S)-protein (S-Trimer) combined with two different adjuvants.

Composition of early life leukocyte populations in preterm infants with and without late-onset sepsis

Composition of leukocyte populations in the first month of life remains incompletely characterised, particularly in preterm infants who go on to develop late-onset sepsis (LOS). The aim of the study was to characterise and compare leukocyte populations in preterm infants with and without LOS during the first month of life.

An Observational Study to Assess the Effectiveness of 4CMenB against Meningococcal Disease and Carriage and Gonorrhea in Adolescents in the Northern Territory, Australia—Study Protocol

Invasive meningococcal disease (IMD) causes significant morbidity and mortality worldwide with serogroup B being the predominant serogroup in Australia and other countries for the past few decades. The licensed 4CMenB vaccine is effective in preventing meningococcal B disease. Emerging evidence suggests that although 4CMenB impact on carriage is limited, it may be effective against gonorrhoea due to genetic similarities between Neisseria meningitidis and Neisseria gonorrhoeae.

Prevalence and subtyping of biofilms present in bronchoalveolar lavage from children with protracted bacterial bronchitis or non-cystic fibrosis bronchiectasis: a cross-sectional study

Lower airway biofilms are hypothesised to contribute to poor treatment outcomes among children with chronic lung disease; however, data are scarce.

B Part of It School Leaver Study: A Repeat Cross-Sectional Study to Assess the Impact of Increasing Coverage With Meningococcal B (4CMenB) Vaccine on Carriage of Neisseria meningitidis

Recombinant protein-based vaccines targeting serogroup B meningococci protect against invasive disease but impacts on carriage are uncertain. This study assessed carriage prevalence of disease-associated meningococci in 2018-2020 as the proportion of vaccinated adolescents increased following introduction of a school-based 4CMenB immunization program.

Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

The purpose of this double-blind, randomised, controlled trial is to compare allergic outcomes in children following vaccination with acellular pertussis (aP) antigen (standard of care in Australia) given at 2 months of age versus whole cell pertussis (wP) in the infant vaccine schedule.

Altered Behavior in Encephalitis: Insights From the Australian Childhood Encephalitis Study, 2013-2018

Altered mental status is a major criterion for a diagnosis of encephalitis to be made with alteration in behavior, a key manifestation of altered mental status. We reviewed all evaluated cases identified by the Australian Childhood Encephalitis study between May 2013 and June 2018.

Pertussis Disease and Antenatal Vaccine Effectiveness in Australian Children

Population-level studies of severe pertussis extending beyond infancy are sparse, and none in the context of antenatal vaccination. We compared hospitalized pertussis cases from birth to 15 years of age before and after introduction of antenatal immunization.

Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial

A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019.

Revaccination with Bacille Calmette-Guérin (BCG) is associated with an increased risk of abscess and lymphadenopathy

The reported frequency and types of adverse events following initial vaccination and revaccination with Bacille Calmette-Guérin (BCG) varies worldwide. Using active surveillance in a randomised controlled trial of BCG vaccination (the BRACE trial), we determined the incidence and risk factors for the development of BCG injection site abscess and regional lymphadenopathy.

Pertussis immunisation in infancy and atopic outcomes: A protocol for a population-based cohort study using linked administrative data

The burden of IgE-mediated food allergy in Australian born children is reported to be among the highest globally. This illness shares risk factors and frequently coexists with asthma, one of the most common noncommunicable diseases of childhood.

BCG vaccination to reduce the impact of COVID-19 in healthcare workers: Protocol for a randomised controlled trial (BRACE trial)

BCG vaccination modulates immune responses to unrelated pathogens. This off-target effect could reduce the impact of emerging pathogens. As a readily available, inexpensive intervention that has a well-established safety profile, BCG is a good candidate for protecting healthcare workers (HCWs) and other vulnerable groups against COVID-19.

Whole-cell pertussis vaccine in early infancy for the prevention of allergy in children

Atopic diseases are the most common chronic conditions of childhood. The apparent rise in food anaphylaxis in young children over the past three decades is of particular concern, owing to the lack of proven prevention strategies other than the timely introduction of peanut and egg.

The reliability of video otoscopy recordings and still images in the asynchronous diagnosis of middle-ear disease

To compare the asynchronous assessment of video otoscopic still images to recordings by an audiologist and ear, nose and throat surgeon (ENT) for diagnostic reliability and agreement in identifying middle-ear disease.

Whole‐cell pertussis vaccine in early infancy for the prevention of allergy in children

Atopic diseases are the most common chronic conditions of childhood. The apparent rise in food anaphylaxis in young children over the past three decades is of particular concern, owing to the lack of proven prevention strategies other than the timely introduction of peanut and egg.

Differences in Pneumococcal and Haemophilus influenzae Natural Antibody Development in Papua New Guinean Children in the First Year of Life

Development of vaccines to prevent disease and death from Streptococcus pneumoniae, and nontypeable Haemophilus influenzae (NTHi), the main pathogens that cause otitis media, pneumonia, meningitis and sepsis, are a global priority.

National predictors of influenza vaccine uptake in pregnancy: the FluMum prospective cohort study, Australia, 2012-2015

Our aim is to ascertain predictors of inactivated influenza vaccine (IIV) uptake in pregnancy in mother-infant pairs from six Australian sites over four consecutive influenza seasons (2012-2015).

Lack of effectiveness of 13-valent pneumococcal conjugate vaccination against pneumococcal carriage density in Papua New Guinean infants

Papua New Guinea (PNG) introduced the 13-valent pneumococcal conjugate vaccine (PCV13) in 2014, with administration at 1, 2, and 3 months of age. PCV13 has reduced or eliminated carriage of vaccine types in populations with low pneumococcal carriage prevalence, carriage density and serotype diversity.

Plasma secretory phospholipase A2 as an early marker for late-onset sepsis in preterm infants—a pilot study

Preterm infants are particularly susceptible to bacterial late-onset sepsis (LOS). Diagnosis by blood culture and inflammatory markers have sub-optimal sensitivity and specificity and prolonged reporting times. There is an urgent need for more rapid, accurate adjunctive diagnostics in LOS to improve management and minimise antibiotic exposure.

PCV10 elicits Protein D IgG responses in Papua New Guinean children but has no impact on NTHi carriage in the first two years of life

Nasopharyngeal colonisation with nontypeable Haemophilus influenzae (NTHi) is associated with development of infections including pneumonia and otitis media. The 10-valent pneumococcal conjugate vaccine (PCV10) uses NTHi Protein D (PD) as a carrier. Papua New Guinean children have exceptionally early and dense NTHi carriage, and high rates of NTHi-associated disease.

Optimising a 6-plex tetanus-diphtheria-pertussis fluorescent bead-based immunoassay

Small volume assays are required for large-scale research studies and in particular paediatric trials, where multiple measures are required from a single sample. Fluorescent bead-based technology (Bioplex/Luminex) allows high through-put and simultaneous quantification of multiple analytes in a single test. This technology uses sets of microspheres, each with a unique spectral address that can be coated with a different antigen of interest.

Global molecular diversity of RSV – the “INFORM RSV” study

Respiratory syncytial virus (RSV) is a global cause of severe respiratory morbidity and mortality in infants. While preventive and therapeutic interventions are being developed, including antivirals, vaccines and monoclonal antibodies, little is known about the global molecular epidemiology of RSV. INFORM is a prospective, multicenter, global clinical study performed by ReSViNET to investigate the worldwide molecular diversity of RSV isolates collected from children less than 5 years of age.

An observational study of the reactogenicity and immunogenicity of 13-valent pneumococcal conjugate vaccine in women of childbearing age in Papua New Guinea

Maternal immunization with pneumococcal conjugate vaccine (PCV) may protect young infants in high-risk settings against the high risk of pneumococcal infections in early life. The aim of this study was to determine the safety and immunogenicity of 13-valent PCV (PCV13) in healthy women of childbearing age in PNG.

Djaalinj Waakinj (listening talking): Rationale, cultural governance, methods, population characteristics–an urban Aboriginal birth cohort study of otitis media

The majority of Australian Aboriginal and Torres Strait Islander (hereafter referred to as “Aboriginal”) people live in urban centres. Otitis media (OM) occurs at a younger age, prevalence is higher and hearing loss and other serious complications are more common in Aboriginal than non-Aboriginal children. Despite this, data on the burden of OM and hearing loss in urban Aboriginal children are limited.

Nasopharyngeal density of respiratory viruses in childhood pneumonia in a highly vaccinated setting: findings from a case-control study

Detection of pneumonia-causing respiratory viruses in the nasopharynx of asymptomatic children has made their actual contribution to pneumonia unclear. We compared nasopharyngeal viral density between children with and without pneumonia to understand if viral density could be used to diagnose pneumonia.

Infant, maternal and demographic predictors of delayed vaccination: A population-based cohort study

Receiving vaccines at or close to their due date (vaccination timeliness) is a now key measure of program performance. However, studies comprehensively examining predictors of delayed infant vaccination are lacking. We aimed to identify predictors of short and longer-term delays in diphtheria-tetanus-pertussis (DTP) vaccination by dose number and ethnicity.

Respiratory Syncytial Virus Vaccination during Pregnancy and Effects in Infants

A multi-country randomized, placebo-controlled trial of the safety, immunogenicity and efficacy of respiratory syncytial virus (RSV) F-protein nanoparticle vaccine was undertaken in 4,636 pregnant women and their infants. RSV F-protein vaccine was safe and immunogenic in the pregnant women inducing anti-F IgG, palivizumab-competing antibodies and RSV neutralizing antibodies that were transferred to the fetus.

Developmental outcomes following vaccine-proximate febrile seizures in children

To compare the developmental and behavioral outcomes of children experiencing an initial vaccine-proximate (VP) febrile seizure (FS) to those having a non-VP-FS (NVP-FS) and controls who have not had a seizure.

Otitis media guidelines for Australian Aboriginal and Torres Strait Islander children: summary of recommendations

The 2001 Recommendations for clinical care guidelines on the management of otitis media in Aboriginal and Torres Islander populations were revised in 2010. This 2020 update by the Centre of Research Excellence in Ear and Hearing Health of Aboriginal and Torres Strait Islander Children used for the first time the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

An observational study of antibody responses to a primary or subsequent pertussis booster vaccination in Australian healthcare workers

Adult pertussis vaccination is increasingly recommended to control pertussis in the community. However, there is little data on the duration and kinetics of immunity to pertussis boosters in adults. We compared IgG responses to vaccination with a tetanus, low-dose diphtheria, low-dose acellular pertussis (Tdap) booster at 1 week, 1 month and 1 year post-vaccination in whole-cell (wP)-primed Australian paediatric healthcare workers who had received an adult Tdap booster 5-12 years previously, to those who received their first Tdap booster. Tdap vaccination was well tolerated in both groups.

An observational study of antibody responses to a primary or subsequent pertussis booster vaccination in Australian healthcare workers

Adult pertussis vaccination is increasingly recommended to control pertussis in the community. However, there is little data on the duration and kinetics of immunity to pertussis boosters in adults. We compared IgG responses to vaccination with a tetanus, low-dose diphtheria, low-dose acellular pertussis (Tdap) booster at 1 week, 1 month and 1 year post-vaccination in whole-cell (wP)-primed Australian paediatric healthcare workers who had received an adult Tdap booster 5-12 years previously, to those who received their first Tdap booster.

Clinician-rated quality of video otoscopy recordings and still images for the asynchronous assessment of middle-ear disease

Video otoscopy plays an important role in improving access to ear health services. This study investigated the clinician-rated quality of video otoscopy recordings and still images, and compared their suitability for asynchronous diagnosis of middle-ear disease. Two hundred and eighty video otoscopy image-recording pairs were collected from 150 children (aged six months to 15 years) by an ear, nose, and throat (ENT) specialist, audiologists, and trained research assistants, and independently rated by an audiologist and ENT surgeon.

Topical versus systemic antibiotics for chronic suppurative otitis media

Chronic suppurative otitis media (CSOM), sometimes referred to as chronic otitis media (COM), is a chronic inflammation and often polymicrobial infection (involving more than one micro-organism) of the middle ear and mastoid cavity, characterised by ear discharge (otorrhoea) through a perforated tympanic membrane. The predominant symptoms of CSOM are ear discharge and hearing loss. Antibiotics are the most common treatment for CSOM, which act to kill or inhibit the growth of micro-organisms that may be responsible for the infection.

OPTIMUM study protocol: an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

Combination vaccines containing whole-cell pertussis antigens were phased out from the Australian national immunisation programme between 1997 and 1999 and replaced by the less reactogenic acellular pertussis (aP) antigens. In a large case-control study of Australian children born during the transition period, those with allergist diagnosed IgE-mediated food allergy were less likely to have received whole-cell vaccine in early infancy than matched population controls (OR: 0.77 (95% CI, 0.62 to 0.95)). We hypothesise that a single dose of whole-cell vaccine in early infancy is protective against IgE-mediated food allergy.

Predictors of hospital readmission in infants less than 3 months old

To examine rates and predictors of 7-day readmission in infants hospitalised before 3 months of age with infectious and non-infectious conditions. A retrospective population-based data-linkage study of 121 854 infants from a 5-year metropolitan birth cohort (2008-2012). Cox proportional hazard models were used to examine associations between infant and maternal factors with 7-day readmission.

Lactoferrin Expression Is Not Associated with Late-Onset Sepsis in Very Preterm Infants

Preterm infants are at a high risk of developing late-onset sepsis (LOS). Lactoferrin is one of the most abundant endogenous antimicrobial proteins expressed in breast milk, stools, and blood, and a candidate for preventive intervention. Large clinical trials have recently investigated whether enteral supplementation with bovine lactoferrin reduces LOS.

Pneumococcal conjugate vaccine primes mucosal immune responses to pneumococcal polysaccharide vaccine booster in Papua New Guinean children

Invasive pneumococcal disease remains a major cause of hospitalization and death in Papua New Guinean (PNG) children. We assessed mucosal IgA and IgG responses in PNG infants vaccinated with pneumococcal conjugate vaccine (PCV) followed by a pneumococcal polysaccharide vaccine (PPV) booster.

Preparing for Life: Plasma Proteome Changes and Immune System Development During the First Week of Human Life

Neonates have heightened susceptibility to infections. The biological mechanisms are incompletely understood but thought to be related to age-specific adaptations in immunity due to resource constraints during immune system development and growth. We present here an extended analysis of our proteomics study of peripheral blood-plasma from a study of healthy full-term newborns delivered vaginally, collected at the day of birth and on day of life (DOL) 1, 3, or 7, to cover the first week of life. The plasma proteome was characterized by LC-MS using our established 96-well plate format plasma proteomics platform.

RSV prophylaxis use in high-risk infants in Western Australia, 2002-2013: a record linkage cohort study

The monoclonal antibody, palivizumab is licensed for use in high-risk infants to prevent severe illness caused by respiratory syncytial virus (RSV). The level of its use and compliance with current jurisdictional guidelines which were amended in 2010, is unknown.

Pediatric Burn Survivors Have Long-Term Immune Dysfunction With Diminished Vaccine Response

Epidemiological studies have demonstrated that survivors of acute burn trauma are at long-term increased risk of developing a range of morbidities. The mechanisms underlying this increased risk remain unknown. This study aimed to determine whether burn injury leads to sustained immune dysfunction that may underpin long-term morbidity. Plasma and peripheral blood mononuclear cells were collected from 36 pediatric burn survivors >3 years after a non-severe burn injury (<10% total body surface area) and from age/sex-matched non-injured controls.

Whole-cell pertussis vaccine in early infancy for the prevention of allergy

This is a protocol for a Cochrane Review (intervention). The objectives were to assess the efficacy and safety of whole‐cell pertussis (wP) vaccinations in comparison to acellular pertussis (aP) vaccinations in early infancy for the prevention of atopic diseases in children.

Whole-Cell Pertussis Vaccination and Decreased Risk of IgE-Mediated Food Allergy: A Nested Case-Control Study

Australian infants who received whole-cell pertussis vaccines were less likely to be diagnosed with food allergy in childhood

Plasma cytokine profiles in very preterm infants with late-onset sepsis

Very preterm infants have a marked innate inflammatory response at the time of late-onset sepsis

Clinical protocol for a longitudinal cohort study to identify markers of vaccine immunogenicity in newborn infants in the gambia and papua New Guinea

Immunity is distinct in early life and greater precision is required in our understanding of mechanisms of early life protection to inform development of new pediatric vaccines

Immunogenicity of the inactivated influenza vaccine in children who have undergone allogeneic haematopoietic stem cell transplant

This study provides evidence to support annual inactivated influenza vaccine administration to children following allogeneic haematopoietic stem cell transplant

Nasal delivery of a commensal Pasteurellaceae species inhibits nontypeable Haemophilus influenzae colonisation and delays onset of otitis media in mice

We have demonstrated that a single dose of a closely related commensal can delay onset of NTHi otitis media in vivo

Panel 7 – Pathogenesis of otitis media – A review of the literature between 2015 and 2019

The most urgent areas appear to be to continue monitoring the emergence of novel otopathogens, and the need to develop prevention and preventative therapies

SCN1A Variants in vaccine-related febrile seizures: A prospective study

Pathogenic SCN1A variants may be identified in infants with vaccine-proximate febrile seizures

Meningococcal B vaccine and meningococcal carriage in adolescents in Australia

Among Australian adolescents, the 4CMenB vaccine had no discernible effect on the carriage of disease-causing meningococci, including group B

Bacterial Reservoirs in the Middle Ear of Otitis-prone Children Are Associated With Repeat Ventilation Tube Insertion

Presence of bacterial otopathogen in the middle ear during ventilation tube insertion was a predictor of children at-risk of repeat ventilation tube insertion

AMEND study protocol: A case-control study to assess the long-term impact of invasive meningococcal disease in Australian adolescents and young adults

This study aims to address this evidence gap by assessing the clinical, physical, neurocognitive, economic and societal impact of invasive meningococcal disease

High concentrations of middle ear antimicrobial peptides and proteins are associated with detection of middle ear pathogens in children with recurrent acute otitis media

Elevated antimicrobial proteins and peptides and cytokines in middle ear effusion are a marker of inflammation and bacterial persistence

S. aureus colonization in healthy Australian adults receiving an investigational S. aureus 3-antigen vaccine

Based on descriptive analyses of this small study, S. aureus 3-antigen vaccine vaccination did not impact S. aureus acquisition or carriage

Effectiveness of Palivizumab against Respiratory Syncytial Virus: Cohort and Case Series Analysis

Palivizumab appeared effective for reducing virologically confirmed respiratory syncytial virus in this high-risk cohort

Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers

One dose of MenACWY-TT boosts protection against MenC in primed children, is safe and extends protection against MenA, MenW and MenY

B Part of It School Leaver protocol: an observational study to assess the impact of a meningococcal serogroup B vaccine programme on carriage of Neisseria meningitidis

This study will assess the impact of MenB vaccine (4CMenB) on carriage prevalence in school leavers in South Australia

Postvaccination Febrile Seizure Severity and Outcome

Vaccine-proximate febrile seizures accounted for a small proportion of all febrile seizures hospital presentations

Safety and immunogenicity of pneumococcal conjugate vaccines in a high-risk population: a randomised controlled trial of PCV in Papua New Guinean infants

Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting

Australian Aboriginal children have higher hospitalization rates for otitis media but lower surgical procedures than non-Aboriginal children

Aboriginal children and children from lower socio-economic backgrounds were over-represented with OM-related hospitalizations but had fewer TTIs

Combination of clinical symptoms and blood biomarkers can improve discrimination between bacterial or viral community-acquired pneumonia in children

Combining elevated CRP with the presence or absence of clinical signs/ symptoms differentiates definite bacterial from presumed viral pneumonia better than CRP alone

Dynamic molecular changes during the first week of human life follow a robust developmental trajectory

Systems biology and innovative data integration can provide fresh insights into the molecular ontogeny of the first week of life

The contribution of viruses and bacteria to community-acquired pneumonia in vaccinated children: A case - Control study

Respiratory viruses, particularly respiratory syncytial virus and human metapneumovirus, are major contributors to pneumonia in Australian children

Varicella vaccine effectiveness over 10 years in Australia; moderate protection from 1-dose program

Although Australia's program has impacted on the burden of varicella disease, single dose Vaccine Effectiveness against varicella hospitalisation is only moderate

Safety and Immunogenicity of MF59-Adjuvanted Cell Culture-Derived A/H5N1 Subunit Influenza Virus Vaccine: Dose-Finding Clinical Trials in Adults and the Elderly

In adult and elderly participants, the full-dose aH5N1c vaccine formulation was well tolerated and met US and European licensure criteria for pandemic vaccines

Research priorities for childhood chronic conditions: a workshop report

Research priorities emphasise a focus on life participation, psychosocial well-being, impact on family and quality of care

Geographical disparities in emergency department presentations for acute respiratory infections and risk factors for presenting

One in four ED presentations in WA children are for ARIs, representing a significant out-of-hospital burden with some evidence of geographical disparity

Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine

A more robust immune response after booster compared to a first dose in vaccine-naïve individuals, showed effective priming in an adolescent/young adult population

Immunogenicity and Immune Memory after a Pneumococcal Polysaccharide Vaccine Booster in a High-Risk Population Primed with Pneumococcal Conjugate Vaccine

PPV is immunogenic in 9-month-old children at high risk of pneumococcal infections and does not affect the capacity to produce protective immune responses

Pcv7-and pcv10-vaccinated otitis-prone children in new zealand have similar pneumococcal and haemophilus influenzae densities in their nasopharynx and middle ear

PCV10 did not reduce NTHi density in the nasopharynx or middle ear, and was associated with increased pneumococcal nasopharyngeal density

The Safety of Influenza and Pertussis Vaccination in Pregnancy in a Cohort of Australian Mother-Infant Pairs, 2012-2015: The FluMum Study

No significant associations were found between maternal inactivated influenza vaccine or pertussis vaccination in pregnancy and adverse birth outcomes

Severe and Complicated Varicella and Associated Genotypes 10 Years After Introduction of a One-Dose Varicella Vaccine Program

Severe hospitalized varicella still occurs with a 1-dose varicella program, although predominantly in unvaccinated children

The impact of influenza infection on young children, their family and the health care system

Influenza infection in young children has a significant impact on medication use, absenteeism and the use of health care service

Immunogenicity and Safety of Monovalent Acellular Pertussis Vaccine at Birth: A Randomized Clinical Trial

The monovalent acellular pertussis vaccine is immunogenic and safe in neonates

Research priority setting in childhood chronic disease: a systematic review

Research priority setting activities in paediatric chronic disease cover many discipline areas and have elicited a broad range of topics

Exposure to chorioamnionitis alters the monocyte transcriptional response to the neonatal pathogen Staphylococcus epidermidis

Our findings suggest that prenatal exposure to inflammation may alter the risk of sepsis in preterm infants partly by modulation of monocyte responses to pathogens

B Part of It protocol: a cluster randomised controlled trial to assess the impact of 4CMenB vaccine on pharyngeal carriage of Neisseria meningitidis in adolescents

The SA MenB vaccine carriage study aims to assess the impact of 4CMenB on carriage of N. meningitidis in adolescents

Topical versus systemic antibiotics for chronic suppurative otitis media

To assess the relative effectiveness of topical versus systemic antibiotics for people with chronic suppurative otitis media

Evidence of functional cell-mediated immune responses to nontypeable Haemophilus influenzae in otitis-prone children

These data provide evidence that otitis-prone children do not have impaired functional cell mediated immunity

Immunogenicity and safety of one or two doses of the quadrivalent meningococcal vaccine MenACWY-TT given alone or with the 13-valent pneumococcal conjugate vaccine in toddlers: A phase III, open-label, randomised study

We evaluated the immunogenicity and safety of 1 and 2 doses of MenACWY-TT, given alone or co-administered with PCV13 in toddlers.

Role of viral and bacterial pathogens in causing pneumonia among Western Australian children: A case-control study protocol

Pneumonia is the leading cause of childhood morbidity and mortality globally.

Identification of generic and pathogen-specific cord blood monocyte transcriptomes reveals a largely conserved response in preterm and term newborn infants

These data provide novel insights into the functionality of neonatal monocytes at birth

Protocol for Pertussis Immunisation and Food Allergy (PIFA): a case-control study of the association between pertussis vaccination in infancy

We therefore speculate that removal of wP from the vaccine schedule contributed to the observed rise in IgE-mediated food allergy among Australian infants

Rationale and methods of a randomized controlled trial of immunogenicity, safety and impact on carriage of pneumococcal conjugate and polysaccharide vaccines in infants in Papua New Guinea

Vaccination trials in high endemicity areas are needed to provide evidence and guidance on idea strategies to protect children in these areas against infections

Epidemiology of invasive meningococcal b disease in Australia, 1999-2015: Priority populations for vaccination

To describe trends in the age-specific incidence of serogroup B invasive meningococcal disease (IMD) in Australia, 1999-2015

Immunogenicity and safety of single-dose, 13-valent pneumococcal conjugate vaccine in pediatric and adolescent oncology patients

All children who are receiving therapy for cancer should receive a single dose of PCV13 as soon as possible after diagnosis, regardless of prior PCV exposure.

Human alkaline phosphatase dephosphorylates microbial products and is elevated in preterm neonates with a history of late-onset sepsis

The aim of our study was to characterize the activity of TNAP on TLR agonists and assess the concentrations of plasma ALP during late-onset sepsis in newborns.

Evaluation of Combination Measles-Mumps-Rubella-Varicella Vaccine Introduction in Australia

To evaluate the effect on safety and coverage of earlier (18 m) scheduling of MMRV vaccine as the second dose of measles-containing vaccine in Australia.

Differences in the population structure of Neisseria meningitidis in two Australian states: Victoria and Western Australia

In this study, invasive meningococcal disease isolates from the western seaboard of Australia, WA, were compared to those of VIC from 2008 to 2012.

Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding

We assessed replication and excretion of the live attenuated CYD-TDV into biological fluids following vaccination in dengue-naive adults in Australia.

Pneumococcal responses are similar in Papua New Guinean children aged 3-5 years vaccinated in infancy with pneumococcal polysaccharide vaccine with or without prior pneumococcal conjugate vaccine, or without pneumococcal vaccination

We studied in a non-randomized follow-up trial the persistence of pneumococcal immunity in children, 3-5 years of age, in community controls of a similar age.

Viral etiology and the impact of codetection in young children presenting with influenza-like illness

Children with acute respiratory tract infection (ARTI) frequently exhibit virus-virus codetection, yet the clinical significance of ARTI remains contentious.

Genetic Variants in the IL-4/IL-13 Pathway Influence Measles Vaccine Responses and Vaccine Failure in Children from Mozambique

We investigated IL-4, IL-13, and IL-4Rα polymorphisms and their impact on measles IgG responses and measles vaccine failure, in two separate cohort.

Australian Aboriginal children with otitis media have reduced antibody titers to specific nontypeable Haemophilus influenzae vaccine antigens

decreased serum IgG responses to NTHi outer membrane proteins may contribute to the development of chronic and severe OM in Australian Aboriginal children

Otitis-prone children produce functional antibodies to pneumolysin and pneumococcal polysaccharides

The production of functional antipneumococcal antibodies in otitisprone children demonstrates that they respond to the current pneumococcal conjugate vaccine (PCV)and are likely to respond to pneumolysin-based vaccines as effectively as healthy children.

Birth outcomes for Australian mother-infant pairs who received an influenza vaccine during pregnancy, 2012-2014: The FluMum study

We assessed the safety of receiving an influenza vaccination during any trimester of pregnancy with respect to preterm births and infant birthweight.

No evidence for impaired humoral immunity to pneumococcal proteins in Australian Aboriginal children with otitis media

Conserved vaccine candidate proteins from S.pneumoniae induce serum and salivary antibody responses in Aboriginal and non-Aboriginal children with history of OM

Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086

Assessment of the persistence of bactericidal antibodies up to 4 years after a three-dose schedule of bivalent rLP2086

An observational study of febrile seizures: The importance of viral infection and immunization

Determine the frequency of detection of specific viral pathogens in children with febrile seizures

Limited impact of neonatal or early infant schedules of 7-valent pneumococcal conjugate vaccination

Early 7vPCV schedules have limited impact on pneumococcal vaccine type carriage in PNG

Safety and immunogenicity of a booster dose of a 3-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults: A randomized phase 1 study

Immune responses after the initial vaccination persisted for the 12 months studied, with little additional response after the booster dose at 6 months

Biofilm forming potential and antimicrobial susceptibility of newly emerged Western Australian Bordetella pertussis clinical isolates

Isobaric tags for relative and absolute quantitation (iTRAQ)-based proteomic analysis revealed significant differences in protein expression in B. pertussis biofilms

Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial

This study assessed the efficacy of seasonal IIV3s against influenza due to 2008 and 2009 seasonal influenza strains and against the 2009 pandemic H1N1 strain

Duplex quantitative PCR assay for detection of haemophilus influenzae that distinguishes fucose-and protein d-negative strains

Developed a specific Haemophilus influenzae quantitative PCR (qPCR) that also identifies fucose-negative and protein D-negative strains

A longitudinal study of natural antibody development to pneumococcal surface protein A families 1 and 2 in Papua New Guinean Highland children: a cohort study

Pneumococcal surface protein A is immunogenic and natural anti-PspA immune responses are acquired through exposure and develop with age

Levels of innate immune factors in preterm and term mothers' breast milk during the 1st month postpartum

Preterm breast milk contains significantly higher concentrations of some immune proteins than term breast milk

Influenza vaccine effectiveness and uptake in children at risk of severe disease

Participation in the preschool influenza vaccination program remains low with parents unconvinced of the benefits and safety of influenza vaccine

Immunogenicity and clinical effectiveness of the trivalent inactivated influenza vaccine in immunocompromised children undergoing treatment for cancer

The trivalent inactivated influenza vaccine is safe, immunogenic, provides clinical protection and should be administered annually to immunosuppressed children receiving treatment for cancer

A prospective cohort study assessing the reactogenicity of pertussis and influenza vaccines administered during pregnancy

Data on systemic and local reactions following receipt of TIV and dTpa during pregnancy support the safety of antenatal vaccination

Five-Year Antibody Persistence And Safety Following a Combined Haemophilus Influenzae Neisseria Meningitidis Tetanus Toxoid Vaccines

The purpose of this article is to investigate whether the number and timing of stressors experienced during pregnancy impacted longterm motor development at...

The effectiveness of influenza vaccination in preventing hospitalisation in children in Western Australia

This study aimed to determine the vaccine effectiveness of the southern hemisphere trivalent inactivated influenza vaccine (TIV) in preventing...

Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: A randomised study

This trial tested the safety & consistency of the immune responses elicited by three consecutive lots of tetravalent dengue vaccine.

Group a streptococcal carriage and seroepidemiology in children up to 10 years of age in Australia.

This study aimed to acquire nationally representative epidemiological data on GAS in Australia to scope the appropriate age for vaccination with a potential...

Immune responses to a recombinant, four-component, meningococcal serogroup B vaccine (4CMenB) in adolescents

This trial evaluated the lot consistency, early immune responses and safety of the vaccine against serogroup B Neisseria meningitidis (4CMenB) - in 11 to 17...

Comparison of text-messaging to voice telephone interviews for active surveillance of adverse events following immunisation.

This study was designed to compare data collected via SMS and telephone for the purposes of monitoring vaccine safety.

Antibody persistence in Australian adolescents following meningococcal C conjugate vaccination

In Australia, following the introduction of serogroup C meningococcal (MenC) conjugate vaccine for toddlers and catch-up immunization through adolescence,...

A randomized phase I study of the safety and immunogenicity

In this study of healthy adults aged 50-85 and 18-24 years, SA3Ag elicited a rapid and robust immune response and was well tolerated, with no notable safety...

A prospective cohort study comparing the reactogenicity of trivalent influenza vaccine in pregnant and non-pregnant women.

Influenza vaccination during pregnancy can prevent serious illness in expectant mothers and provide protection to newborns...

HPV.edu study protocol: A cluster randomised controlled evaluation of education, decisional support and logistical strategies...

The National Human Papillomavirus (HPV) Vaccination Program in Australia commenced in 2007 for females and in 2013 for males, using the quadrivalent HPV...

Human infant memory B cell and CD4+ T cell responses to HibMenCY-TT glyco- conjugate vaccine

Carrier-specific T cell and polysaccharide-specific B cell memory responses are not well characterised in infants following glyco-conjugate vaccination.

Febrile seizures following measles and varicella vaccines in young children in Australia

Febrile seizures (FS) are common in childhood with incidence peaking in the second year of life when measles and varicella-containing vaccines are administered.

Detection of biofilm in bronchoalveolar lavage from children with non-cystic fibrosis bronchiectasis

The presence of Pseudomonas aeruginosa biofilms in lower airway specimens from cystic fibrosis (CF) patients is well established.

Molecular tools for differentiation of non-typeable Haemophilus influenzae from Haemophilus haemolyticus

The molecular approaches that have been developed for differentiation of NTHi from H. haemolyticus, with the advantages and disadvantages of each target

The safety of seasonal influenza vaccines in Australian children in 2013

Our objective was to examine influenza vaccine safety in Australian children aged under 10 years in 2013.

Predictors of Disease Severity in Children Hospitalized for Pertussis during an Epidemic

This study aimed to determine factors associated with severe pertussis in hospitalized children during an epidemic using a novel pertussis severity scoring...

FluMum: A prospective cohort study of mother-infant pairs assessing the effectiveness of maternal influenza vaccination in revention of influenza

Evidence is emerging of benefit to the infant with respect to preventing influenza infection in the first 6 months of life. The FluMum study aims to...

The impact of pandemic A(H1N1)pdm09 influenza and vaccine-associated adverse events on parental attitudes and influenza vaccine uptake in young children

This paper reports on the shift in parental attitude to vaccination after 2010, due to an unprecedented increase in febrile reactions in children receiving...

Effectiveness of trivalent flu vaccine in healthy young children

This paper reports some of the findings from the Western Australian Influenza Vaccine Effectiveness Study, commenced in 2008, to evaluate a program providing...

Diversity of Nontypeable Haemophilus influenzae strains colonizing Australian Aboriginal and non-Aboriginal children

Nontypeable Haemophilus influenzae (NTHI) strains are responsible for respiratory-related infections which cause a significant burden of disease in...

Safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population

This study examined the safety and immunogenicity of a vero cell culture-derived whole-virus influenza a(H5N1) vaccine in a pediatric population.

High Nasopharyngeal Carriage of Non-Vaccine Serotypes in Western Australian Aboriginal People Following 10 Years of Pneumococcal Conjugate Vaccination

Invasive pneumococcal disease (IPD) continues to occur at high rates among Australian Aboriginal people.

Impact of CD14 promoter variants on measles vaccine responses and vaccine failure in children from Australia and Mozambique

Host genetics are likely to play a crucial role, particularly variants that alter key innate immune response genes.

International collaboration to assess the risk of Guillain Barré Syndrome following Influenza A (H1N1) 2009 monovalent vaccines.

The global spread of the 2009 novel pandemic influenza A (H1N1) virus led to the accelerated production and distribution of monovalent 2009 Influenza A...

Does a 10-valent pneumococcal-Haemophilus influenzae protein D conjugate vaccine prevent respiratory exacerbations in children

Our study will be the first to assess vaccine efficacy targeting H. influenzae in children with recurrent PBB, CSLD and bronchiectasis.

Clinical Predictors of Influenza in Young Children: The Limitations of “Influenza-Like Illness”

This study aims to identify clinical predictors of influenza infection in children ≤5 years old from which age-specific ILI definitions are then constructed.

How Accurate Are International Classification of Diseases-10 Diagnosis Codes in Detecting Influenza and Pertussis Hospitalizations in Children?

Influenza diagnosis codes had high specificity (98.6%) and modest positive predictive value (PPV; 84.1%) and sensitivity (86.1%) for a laboratory-confirmed...

Virus detection and its association with symptoms during influenza-like illness in a sample of healthy adults

Our findings indicate that a greater number of symptoms are displayed by individuals presenting with influenza confirmed ILI compared with other agents that...

Safety and tolerability of a 2009 trivalent inactivated split-virion influenza vaccine in infants, children and adolescents

To evaluate the safety of CSL's split-virion inactivated trivalent 2009 Southern Hemisphere formulation influenza vaccine (TIV) in children.

A randomized, controlled, phase 1/2 trial of a neisseria meningitidis serogroup B bivalent rLP2086 vaccine in healthy children and adolescents

Factor H binding protein (also known as LP2086) is a conserved outer membrane neisserial lipoprotein that has emerged as a strong candidate protein antigen...

A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults

No currently licensed and available vaccine has been shown to provide broad protection against endemic MnB disease.

High pneumococcal serotype specific IgG, IgG1 and IgG2 levels in serum and the middle ear of children with recurrent acute otitis media

Recurrent acute otitis media (AOM), frequently caused by Streptococcus pneumoniae, is a major paediatric health problem.

Safety surveillance of influenza vaccine in pregnant women

Vaccination is the most effective strategy for preventing influenza infection in pregnancy.

A national prospective surveillance study of acute rheumatic fever in Australian children

Acute rheumatic fever (ARF) is an important cause of heart disease in Indigenous people of northern and central Australia.

Safety and Immunogenicity of Neonatal Pneumococcal Conjugate Vaccination in Papua New Guinean Children: A Randomised Controlled Trial

We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in...

Neutrophil Extracellular Traps and Bacterial Biofilms in Middle Ear Effusion of Children with Recurrent Acute Otitis Media

Bacteria persist within biofilms on the middle ear mucosa of children with recurrent and chronic otitis media however the mechanisms by which these...

New findings in the pathogenesis of otitis media

This study was the first to concurrently identify middle ear pathogens in both bacterial biofilm and intracellularly in the middle ear mucosa of children and to identify extensive DNA stranding in the MEF from children with AOM

Neonatal antigen-presenting cells are functionally more quiescent in children born under traditional compared with modern environmental conditions

One explanation for the high burden of allergic and autoimmune diseases in industrialized countries is inappropriate immune development under modern...

Nasopharyngeal carriage of Streptococcus pneumoniae: prevalence and risk factors in HIV-positive children in Tanzania

Pneumococcal colonization of the nasopharynx is especially common in young children and is a pre-requisite for pneumococcal disease...

Safety and immunogenicity of a meningococcal B bivalent rLP2086 vaccine in healthy toddlers Aged 18-36 months

A bivalent, recombinant, factor H-binding protein (rLP2086) vaccine was developed to protect against invasive Neisseria meningitidis serogroup B (MnB) in...

A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults:

Neisseria meningitidis is a leading cause of meningitis and septicaemia, but a broadly-protective vaccine against endemic serogroup B disease is not licensed...

Polymorphisms in key innate immune genes and their effects on measles vaccine responses and vaccine failure in children from Mozambique

Despite an effective vaccine, measles remains a major health problem globally, particularly in developing countries. More than 30% of children show primary...

Can linked emergency department data help assess the out-of-hospital burden of acute lower respiratory infections

There is a lack of data on the out-of-hospital burden of acute lower respiratory infections (ALRI) in developed countries.

Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered

A pooled analysis was conducted of 1,257 toddlers who received a fourth dose of Haemophilus influenzae type b- Neisseria meningitidis serogroups C and...

TLR3 and RIG-I gene variants: Associations with functional effects on receptor expression and responses to measles viru

Measles virus causes severe morbidity and mortality, despite the availability of measles vaccines. Successful defence against viral pathogens requires early...

Reduction in disparity for pneumonia hospitalisations between Australian indigenous and non-Indigenous children

In the 1990s pneumonia hospitalisation rates in Western Australia (WA) were 13 times higher in Indigenous children than in non-Indigenous children...

Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy

Neisseria meningitidis serogroup B is a major cause of invasive meningococcal disease, but a broadly protective vaccine is not currently licensed. A bivalent...

Hospitalisation for bronchiolitis in infants is more common after elective caesarean delivery

The authors previously reported an increased risk of hospitalisation for acute lower respiratory infection up to age 2 years in children delivered by...

CD46 measles virus receptor polymorphisms influence receptor protein expression

Despite the availability of measles vaccines, infants continue to die from measles. Measles vaccine responses vary between individuals, and poor...

Virus detection and its association with symptoms during influenza-like illness in a sample of healthy adults enrolled in a randomised controlled vaccine trial

Viral respiratory infections are associated with significant morbidity and mortality.

Children with otitis media mount a pneumococcal serotype specific serum IgG and IgA response comparable to healthy controls after pneumococcal conjugate vaccination

We investigated the suggestion that otitis-prone children have an impaired antibody response in the context of pneumococcal vaccination.

Molecular surveillance of true nontypeable haemophilus influenzae: An evaluation of pcr screening assays

Unambiguous identification of nontypeable Haemophilus influenzae (NTHi) is not possible by conventional microbiology. Molecular characterisation of...

Impacts on influenza A(H1N1)pdm09 infection from cross-protection of seasonal trivalent influenza vaccines and A(H1N1)pdm09 vaccines: Systematic review and meta-analyses

We did a systematic literature search to identify observational and/or interventional studies reporting cross-protection of TIV and A(H1N1)pdm09...

Toll-like receptor 7 and 8 polymorphisms: Associations with functional effects and cellular and antibody responses to measles virus and vaccine

The functionality and effects of TLR7 and TLR8 polymorphisms on cellular and antibody responses was investigated after the first measles vaccine dose.

A genomics-based approach to assessment of vaccine safety and immunogenicity in children

This methodology has significant potential to identify covert interactions between inflammatory pathways triggered by vaccination, and as such may be a...

Histiologic chorioamnionitis is associated with reduced incidence of late-onset sepsis in very preterm infants

Histologic chorioamnionitis (HCA) is implicated in the onset of preterm labor and delivery. Chorioamnionitis is a known risk factor for early-onset sepsis...

IgG Responses to Pneumococcal and Haemophilus Influenzae Protein Antigens Are Not Impaired in Children with a History of Recurrent Acute Otitis Media

Vaccines including conserved antigens from Streptococcus pneumoniae & nontypeable Haemophilus influenzae have the potential to reduce of otitis media.

Use of data linkage to investigate the aetiology of acute lower respiratory infection hospitalisations in children

The aim was to document the aetiology of acute lower respiratory infection (ALRI) hospitalisations in Western Australian children

High detection rates of nucleic acids of a wide range of respiratory viruses in the nasopharynx and the middle ear

Both bacteria and viruses play a role in the development of acute otitis media, however, the importance of specific viruses is unclear.

Hospitalisation for bronchiolitis in infants is more common after elective caesarean delivery

The authors previously reported an increased risk of hospitalisation for acute lower respiratory infection up to age 2 years in children delivered by...

Toll-like receptor 7 and 8 polymorphisms: associations with functional effects and cellular and antibody responses to measles virus and vaccine

Successful defence against viral pathogens requires the rapid recognition of virus-specific "danger signals" and the activation of both innate and adaptive...

Method of bacterial killing differentially affects the human innate immune response to Staphylococcus epidermidis

In vitro investigations of human innate immune responses to extracellular bacteria commonly utilise killed preparations in preference to live...

Reactogenicity of two 2010 trivalent inactivated influenza vaccine formulations in adults

The objective of this tudy was to assess the reactogenicity of two 2010 trivalent inactivated influenza vaccine (TIV) formulations among adults, including...

Pneumococcal conjugate vaccination at birth in a high-risk setting: No evidence for neonatal T-cell tolerance

Concerns about the risk of inducing immune deviation-associated "neonatal tolerance" as described in mice have restricted the widespread adoption...

Predominance of nontypeable haemophilus influenzae in children with otitis media

In Australia the 7-valent pneumococcal conjugate vaccine (PCV7) is administered at 2, 4 and 6 months of age, with no booster dose.

Slam and dc-sign measles receptor polymorphisms and their impact on antibody and cytokine responses to measles vaccine

Despite the use of measles vaccine, measles virus continues to circulate and cause severe disease

Trivalent influenza vaccine and febrile adverse events in australia, 2010: Clinical features and potential mechanisms

Increased numbers of children presenting with febrile adverse events following trivalent influenza vaccine (TIV) were noted in Australia in 2010.

Preterm infants have deficient monocyte and lymphocyte cytokine responses to group B streptococcus

Group B streptococcus (GBS) is an important cause of early- and late-onset sepsis in the newborn. Preterm infants have markedly increased susceptibility...

Immediate and Longer Term Immunogenicity and Safety of a Single Dose of the Combined Haemophilus influenzae Type

Hib-primed but MenC-naive toddlers (N = 433) were randomized to receive 1 dose of Hib-MenC-TT or separate Hib-TT and MenC-CRM197 vaccines.

Immunogenicity and safety of a combined Haemophilus influenzae type b-Neisseria

Neisseria meningitidis serogroups B, C, and Y cause most meningococcal disease in industrialized countries...

Vaccine Effectiveness Against Laboratory-confirmed Influenza in Healthy Young Children A Case-Control Study

The Western Australian Influenza Vaccine Effectiveness study commenced in 2008 to evaluate a new program to provide free influenza vaccine to all children...

Innate immunity in human newborn infants: prematurity means more than immaturity

Neonates, particularly those born prematurely, are exquisitely vulnerable to life-threatening infections. This increased susceptibility to infection...

Maternal, umbilical cord and neonatal inflammatory and hematologic markers in histologic chorioamnionitis

Maternal, umbilical cord, neonatal inflammatory, hematologic markers, histologic chorioamnionitis...

A retrospective population-based cohort study identifying target areas for prevention of acute lower respiratory infections in children

Acute lower respiratory infections (ALRI) are a major cause of hospitalisation in young children

Are you listening? The inaugural OMOZ Workshop - towards a better understanding of otitis media

Are you listening? The inaugural OMOZ Workshop - towards a better understanding of otitis media

Method of bacterial killing differentially affects the human innate immune response to Staphylococcus epidermidis

In vitro investigations of human innate immune responses to extracellular bacteria commonly utilise killed preparations in preference to live organisms

Nasopharyngeal carriage of Haemophilus haemolyticus in otitis-prone and healthy children

Haemophilus haemolyticus is often incorrectly categorized as nontypeable Haemophilus influenzae (NTHI) upon culture. PCR analyses of 266 NTHI-like nasopharyngea

Assessing the protective effect of influenza vaccine against laboratory confirmed influenza in hospitalised children aged 6-59 months

Influenza vaccine was offered to all children aged 6-59 months resident in Western Australia in 2008, and we wished to evaluate the effectiveness of this immunisation programme.

Lessons from the first year of the WAIVE study investigating the protective effect of influenza vaccine

Influenza is major cause of paediatric hospitalisation. Influenza vaccine was offered to all children aged 6-59 months resident in Western Australia in 2008

The changing epidemiology of invasive pneumococcal disease

We investigated trends in invasive pneumococcal disease (IPD) in Western Australia (WA).

TLR2 mediates recognition of live staphylococus epidermidis

Staphylococcus epidermidis is a nosocomial pathogen that causes catheter-associated bacteremia in the immunocompromised, including those at the extremes of age

Th2-polarisation of cellular immune memory to neonatal pertussis vaccination

Current infant vaccination against pertussis in North America and Australia requires three doses of vaccines including diphtheria, tetanus and acellular...

Response after one dose of monovalent influenza A (H1n1) 2009 vaccine in infants and children - preliminary report

To assess the immunogenicity and safety of a 2009 influenza A(H1N1) vaccine in children.

Reduced levels of antimicrobial proteins and peptides in human cord blood plasma

Reduced levels of antimicrobial proteins and peptides in human cord blood plasma.

Safety and Immunogencity of a Prototype Adjuvanted Inactivated Split-Virus Influenza A (H5N1) Vaccine in Infants and Children

Highly pathogenic avian influenza A virus (H5N1) is a leading candidate for the next influenza pandemic, and infants and children may play an important role...

The role of chronic infection in children with otitis media with effusion: Evidence for intracellular persistence of bacteria

Demonstrate mucosal bacterial infection in children with otitis media with effusion (OME).

A DTPa-HBV-IPV vaccine for primary vaccination of infants

Combined vaccines have an increasingly important role to play in delivering these antigens acceptably.

Diverging trends for lower respiratory infections in non-Aboriginal and Aboriginal children

To investigate temporal trends in admission rates for acute lower respiratory infections (ALRI) in a total population birth cohort of non-Aboriginal and...

Infection is the major component of the disease burden in Aboriginal and non-Aboriginal Australian children: a population-based study

Infection accounts for the majority of pediatric mortality and morbidity in developing countries, but there are limited data on the infectious diseases...

The effects of maternal smoking on early mucosal immunity and sensitization at 12 months of age

In this study, we examined the effects of maternal smoking as a major adverse exposure in early life, on mucosal immune function and allergen sensitization...

Assessment of the potency and potential immunomodulatory effects of the Measles Mumps Rubella-Varicella vaccine in infants

This study compared the potency and immunomodulatory effects of measles mumps rubella (MMR) vaccine given to infants alone or in combination with varicella...

The burden of rotavirus-related illness among young children on the Australian health care system

To provide estimates of the annual number and cost of hospital admissions, emergency department (ED) visits and general practitioner (GP) visits...

A comparison of booster immunisation with a combination DTPa-IPV vaccine or DTPa plus IPV in separate injections when co-administered with MMR

This study evaluated GSK's combined DTPa-IPV vaccine (Infanrix-IPV) given as a fifth consecutive acellular pertussis booster dose in conjunction...

Toll-like receptor 2 ligands inhibit Th2 responses to mite allergen

There is intense interest in the interaction between microbial compounds and allergy.

Immunogenicity and boosting following a reduced number of doses of a Pneumococcal Conjugate Vaccine in infants and toddlers

The minimum number of doses of pneumococcal conjugate vaccine required for protection is not known. We studied the immunogenicity of a reduced schedule in...

Safety and immunogenicity of a combined DTPa-IPV vaccine administered as a booster from 4 years of age: a review

A combined DTPa-IPV booster vaccine was administered as a 4th or 5th dose after DTPa or DTPw priming.