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|Title:||A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults|
|Citation:||Vaccine, 2013; 31(12):1569-1575|
|Publisher:||Elsevier Sci Ltd|
|Helen S. Marshall, Peter C. Richmond, Michael D. Nissen, Ann Wouters, James Baber, Qin Jiang, Annaliesa S. Anderson, Thomas R. Jones, Shannon L. Harris, Kathrin U. Jansen, John L. Perez|
|Abstract:||<h4>Background</h4>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.<h4>Methods</h4>This study assessed the safety and immunogenicity of the final formulation of a bivalent rLP2086 vaccine in 60 healthy adults (18-40 years of age) receiving 120 μg doses at 0, 1, and 6 months. Safety was assessed by collecting solicited reactogenicity data and participant-reporting of adverse events. Immunogenicity was evaluated by human serum bactericidal assay (hSBA) against 5 MnB strains expressing distinct fHBP variants and fHBP-specific immunoglobulin G titre.<h4>Results</h4>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 (hSBA titres ≥ 1:4) 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 (≥ 4-fold rise in hSBA titres) 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.<h4>Conclusions</h4>Bivalent rLP2086 is a promising vaccine candidate for broad protection against MnB disease-causing strains.|
|Keywords:||Meningococcal vaccines; Bacterial outer membrane proteins; Bactericidal antibodies; Factor H binding protein; Serum bactericidal assay; Neisseria meningitidis serogroup B|
|Rights:||© 2013 Elsevier Ltd. All rights reserved.|
|Appears in Collections:||Paediatrics publications|
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