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https://hdl.handle.net/2440/78339
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Type: | Journal article |
Title: | A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults |
Author: | Marshall, H. Richmond, P. Nissen, M. Wouters, A. Baber, J. Jiang, Q. Anderson, A. Jones, T. Harris, S. Jansen, K. Perez, J. |
Citation: | Vaccine, 2013; 31(12):1569-1575 |
Publisher: | Elsevier Sci Ltd |
Issue Date: | 2013 |
ISSN: | 0264-410X 1873-2518 |
Statement of Responsibility: | 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. |
DOI: | 10.1016/j.vaccine.2013.01.021 |
Published version: | http://dx.doi.org/10.1016/j.vaccine.2013.01.021 |
Appears in Collections: | Aurora harvest Paediatrics publications |
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