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首页> 外文期刊>Vaccine >A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults
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A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults

机译：健康成年人中脑膜炎球菌B二价rLP2086疫苗的2期开放标签安全性和免疫原性研究

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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 mu g 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
机译：背景：脑膜炎奈瑟菌B血清群（MnB）是青少年和年轻人中细菌性脑膜炎和败血病的主要原因。当前没有获得许可的可用疫苗显示出对地方性MnB疾病的广泛保护。已开发出基于两种因子H结合蛋白（fHBP）的二价rLP2086疫苗，以提供针对MnB致病株的广泛保护。方法：本研究评估了60例健康成年人（18-40岁）在0、1、6个月接受120μg剂量的二价rLP2086疫苗最终制剂的安全性和免疫原性。通过收集征求的反应原性数据和不良事件的参与者报告来评估安全性。通过人血清杀菌试验（hSBA）对表达不同fHBP变体和fHBP特异性免疫球蛋白G滴度的5 MnB菌株评估了免疫原性。结果：每次免疫后，注射部位的疼痛和红斑等局部反应通常为轻度或中度。最常见的疫苗相关不良事件是上呼吸道感染，有两名参与者报告。 94.3％的参与者针对表达疫苗同源fHBP变体A05的MnB菌株实现了血清保护（hSBA滴度> = 1：4），针对表达异源fHBP变体B02，A22，B44和B24。 3剂疫苗接种方案后，在五种MnB测试菌株中，血清转化率（hSBA滴度≥4倍）从70.0％到94.7％。免疫原性反应倾向于在随后的疫苗剂量后增加。结论：二价rLP2086是有希望的疫苗候选物，可广泛预防MnB致病菌株

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