A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults
| Autor: | Thomas R. Jones, Michael D. Nissen, James Baber, Qin Jiang, John L. Perez, Helen Marshall, Peter Richmond, Shannon L. Harris, Annaliesa S. Anderson, Ann Wouters, Kathrin U. Jansen |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male Adolescent Meningococcal Vaccines Meningococcal vaccine Neisseria meningitidis Serogroup B Biology medicine.disease_cause Young Adult Bacterial Proteins medicine Humans Serum Bactericidal Test Seroconversion Adverse effect Immunization Schedule Antigens Bacterial Reactogenicity General Veterinary General Immunology and Microbiology Neisseria meningitidis Immunogenicity Public Health Environmental and Occupational Health Antibodies Bacterial Virology Meningococcal Infections Vaccination Infectious Diseases Immunology Molecular Medicine Female Immunogenicity Study |
| Zdroj: | Vaccine. 31:1569-1575 |
| ISSN: | 0264-410X |
| DOI: | 10.1016/j.vaccine.2013.01.021 |
| Popis: | Background 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. Methods 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. Results 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. Conclusions Bivalent rLP2086 is a promising vaccine candidate for broad protection against MnB disease-causing strains. |
| Databáze: | OpenAIRE |
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