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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.

Authors:
Marshall HS, Richmond PC, Nissen MD, Wouters A, Baber J, Jiang Q, et al.

Authors notes:
Vaccine. 2013;31(12):1569-1575

Keywords:
Bacterial outer membrane proteins, Bactericidal antibodies, Factor H binding protein, Meningococcal vaccines, Neisseria meningitidis serogroup B, Serum bactericidal assay

Abstract:
Neisseria meningitidis serogroup B (MnB) is a leading cause of bacterial meningitis and septicemia in adolescents and young adults.

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

A bivalent rLP2086 vaccine based on two factor H-binding proteins (fHBPs) has been developed to provide broad protection against MnB disease-causing strains.

After each immunisation, local reactions such as pain at the injection site and erythema were generally mild or moderate.

The most common vaccine-related adverse event was upper respiratory tract infection, which was reported by two participants.

Seroprotection was achieved in 94.3% of participants against a MnB strain expressing the vaccine-homologous fHBP variant A05 and 70.0%-94.7% against MnB strains expressing the heterologous fHBP variants B02, A22, B44, and B24.

Seroconversion rates ranged from 70.0% to 94.7% across the five MnB test strains following the 3-dose vaccination regimen.

Immunogenicity responses tended to increase upon subsequent vaccine doses.

Bivalent rLP2086 is a promising vaccine candidate for broad protection against MnB disease-causing strains.