Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial
Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial
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DOI：
10.1016/s0140-6736(09)62003-1
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发表时间：
2010-01-02
期刊：
影响因子：
168.9
通讯作者：
Wang, Yu
中科院分区：
文献类型：
--
作者：
Liang, Xiao-Feng;Wang, Hua-Qing;Wang, Yu
当前的流感大流行需要一种安全有效的疫苗。本研究评估了中国10家生产企业生产的8种2009年甲型H1N1流感疫苗配方的安全性和免疫原性。方法在这项多中心、双盲、随机试验中，在中国10个中心招募了12691名年龄在3岁及以上的患者。在每个中心，参与者按年龄分层，并按随机数字表随机分配，接受几种疫苗制剂中的一种或安慰剂。该研究评估了8种制剂：分裂病毒粒子制剂，每剂含有7.5 μ g、15 μ g或30 μ g血凝素，有或没有氢氧化铝佐剂；全病毒粒子制剂，每剂含有5 μ g或10 μ g血凝素，有佐剂。所有配方均由重组菌株X-179A （A/California/07/2009-A/PR/8/34）生产。我们分析了这些制剂的安全性（不良事件）、免疫原性（血凝抑制抗体几何平均滴度[GMT]）和血清保护（GMT >= 1:40）。分析是按每个方案进行的。两个站点在ClinicalTrials.gov网站注册了他们的试验，编号为NCT00956111和NCT00975572。其他8项研究已在中国国家食品药品监督管理局注册。12691名参与者在第0天接受了第一剂，12348名参与者在第21天接受了第二剂。第一剂疫苗接种后21天的血清保护率从7.5 μ g佐剂分裂病毒粒子制剂的69.5% （95% CI 65.9-72.8）到30 μ g非佐剂分裂病毒粒子制剂的92.8%（91.9-93.6）不等。一剂7.5 μ g非佐剂分裂病毒粒子疫苗接种者的血清保护率为86.5%（920人中有796人；84.1-88.7人），而安慰剂接种者的血清保护率为9.8%（1432人中有140人；8.3-11.4人）
Background The current influenza pandemic calls for a safe and effective vaccine. We assessed the safety and immunogenicity of eight formulations of 2009 pandemic influenza A H1N1 vaccine produced by ten Chinese manufacturers.Methods In this multicentre, double-blind, randomised trial, 12 691 people aged 3 years or older were recruited in ten centres in China. in each Centre, participants were stratified by age and randomly assigned by a random number table to receive one of several vaccine formulations or placebo. The study assessed eight formulations: split-virion formulation containing 7.5 mu g, 15 mu g, or 30 mu g haemagglutinin per dose, with or without aluminium hydroxide adjuvant, and whole-virion formulation containing 5 mu g or 10 mu g haemagglutinin per dose, with adjuvant. All formulations were produced from the reassortant strain X-179A (A/California/07/2009-A/PR/8/34). We analysed the safety (adverse events), immunogenicity (geometric mean titre [GMT] of haemagglutination inhibition antibody), and seroprotection (GMT >= 1:40) of the formulations. Analysis was by per protocol. Two sites registered their trial with ClinicalTrials.gov, numbers NCT00956111 and NCT00975572. The other eight studies were registered with the State Food and Drug Administration of China.Findings 12691 participants received the first dose on day 0, and 12348 participants received the second dose on day 21. The seroprotection rate 21 days after the first dose of vaccine ranged from 69.5% (95% CI 65.9-72.8)for the 7.5 mu g adjuvant split-virion formulation to 92.8% (91.9-93.6) for the 30 mu g non-adjuvant split-virion formulation. The seroprotection rate was 86.5% (796 of 920; 84.1-88.7) in recipients of one dose of the 7.5 mu g non-adjuvant split-virion vaccine compared with 9.8% (140 of 1432; 8.3-11.4) in recipients of placebo (p