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首页> 外文期刊>Vaccine >A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: Results of a randomised, controlled, dose-escalation phase-1 trial
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A bivalent Neisseria meningitidis recombinant lipidated factor H binding protein vaccine in young adults: Results of a randomised, controlled, dose-escalation phase-1 trial

机译：年轻人中的一种二价脑膜炎奈瑟菌重组脂化因子H结合蛋白疫苗：一项随机，对照，剂量递增1期试验的结果

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摘要

Neisseria meningitidis is a leading cause of meningitis and septicaemia, but a broadly-protective vaccine against endemic serogroup B disease is not licensed and available. The conserved, outer-membrane lipoprotein factor H binding protein (fHBP, also known as LP2086) is expressed as one of two subfamily variants in virtually all meningococci. This study investigated the safety, tolerability, and immunogenicity of a recombinant-expressed bivalent fHBP (r-fHBP) vaccine in healthy adults. Participants (N = 103) aged 18–25 years were recruited into three ascending dose level cohorts of 20, 60, and 200 μg of a bivalent r-fHBP vaccine formulation and randomised to receive vaccine or placebo at 0, 1, and 6 months. The vaccine was well tolerated. Geometric mean titres (GMTs) for r-fHBP subfamily-specific IgG antibodies increased 19–168-fold from pre-vaccination to post-dose 2 in a dose level-dependent manner. In addition, robust serum bactericidal assay using human complement (hSBA) responses for strains expressing both homologous and heterologous fHBP variants were observed. After three vaccinations, 16–52% of the placebo group and 47–90%, 75–100%, and 88–100%, of the 20, 60, and 200 μg dose levels, respectively, had seroprotective (≥1:4) hSBA titres against six serogroup B strains. The bivalent r-fHBP vaccine was well tolerated and induced robust bactericidal activity against six diverse serogroup B strains in young adults at the 60 and 200 μg dose levels.
机译：脑膜炎奈瑟氏球菌是脑膜炎和败血病的主要原因，但针对乙型流行性血清群疾病的广泛保护性疫苗尚未获得许可并无法获得。保守的外膜脂蛋白因子H结合蛋白（fHBP，也称为LP2086）在几乎所有脑膜炎球菌中均被表达为两个亚家族变体之一。这项研究调查了健康成年人中重组表达的二价fHBP（r-fHBP）疫苗的安全性，耐受性和免疫原性。 18至25岁的参与者（N = 103）被分为三个递增剂量水平队列，分别为20、60和200μg二价r-fHBP疫苗制剂，并在0、1、6个月随机接受疫苗或安慰剂。疫苗耐受良好。从疫苗接种前到给药后2，r-fHBP亚家族特异性IgG抗体的几何平均滴度（GMT）呈剂量水平依赖性增加19-168倍。另外，对于表达同源和异源fHBP变体的菌株，使用人补体（hSBA）应答进行了强大的血清杀菌试验。接种三剂后，安慰剂组分别有16-52％和20、60和200μg剂量水平的47-90％，75-100％和88-100％具有血清保护作用（≥1：4 ）针对六种B血清型菌株的hSBA效价。在60和200μg剂量水平下，二价r-fHBP疫苗具有良好的耐受性，并在年轻人中针对六种不同的B血清群菌株产生了强大的杀菌活性。

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