Dose-Sparing H5N1 A/Indonesia/05/2005 Pre-pandemic Influenza Vaccine in Adults and Elderly Adults: A Phase III, Placebo-Controlled, Randomized Study
Dose-Sparing H5N1 A/Indonesia/05/2005 Pre-pandemic Influenza Vaccine in Adults and Elderly Adults: A Phase III, Placebo-Controlled, Randomized Study
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DOI：
10.1093/infdis/jir172
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发表时间：
2011-06-15
影响因子：
6.4
通讯作者：
Fries, Louis
中科院分区：
文献类型：
--
作者：
Langley, Joanne M.;Risi, George;Fries, Louis
方法。这项III期、安慰剂对照、观察者盲法研究评估了2剂水包油（AS03(A)）佐剂H5N1 A/Indonesia/05/2005 （3.75 μ g血凝素抗原）大流行前候选疫苗的免疫原性、交叉反应性、安全性和批一致性，共接种了4561名18-91岁的成年人。H5N1疫苗组的体液抗体反应在第二次注射后21天内符合美国和欧洲大流行性流感疫苗的免疫原性许可标准。在首次给药后6个月，血清抗体血清转化率继续满足许可标准。对进化枝1 A/Vietnam/1194/2004证明了中和性跨进化枝免疫反应。连续3批H5N1疫苗证明了一致性。H5N1疫苗组的短暂注射部位疼痛比安慰剂组更常见（18-64岁和65岁年龄组分别为89.3%和70.7%，而安慰剂组为22.2%和14.4%）。截至第364天，两组之间的非主动不良事件发生频率（包括就医和严重事件）相似。在成人和老年人中，AS03(A)佐剂H5N1候选疫苗对A/Indonesia/05/2005具有高度免疫原性，对A/Vietnam/1194/2004具有交叉反应性。H5N1疫苗的短暂注射部位反应比安慰剂更常见，尽管H5N1疫苗总体耐受良好。临床试验注册。NCT00616928。
Methods. This phase III, placebo-controlled, observer-blinded study evaluated the immunogenicity, cross-reactivity, safety, and lot consistency of 2 doses of oil-in-water (AS03(A)) adjuvanted H5N1 A/Indonesia/05/2005 (3.75 mu g hemagglutinin antigen) prepandemic candidate vaccine in 4561 adults aged 18-91 years.Results. Humoral antibody responses in the H5N1 vaccine groups fulfilled US and European immunogenicity licensure criteria for pandemic vaccines in all age strata 21 days after the second dose. At 6 months after the administration of the primary dose, serum antibody seroconversion rates continued to fulfill licensure criteria. Neutralizing cross-clade immune responses were demonstrated against clade 1 A/Vietnam/1194/2004. Consistency was demonstrated for 3 consecutive H5N1 vaccine lots. Temporary injection-site pain was more frequent with H5N1 vaccine than placebo (89.3% and 70.7% in the 18-64 and >= 65 years strata vs 22.2% and 14.4% in the placebo groups). Unsolicited adverse event frequency, including medically attended and serious events, was similar between groups through day 364.Conclusions. In adults and elderly adults, AS03(A)-adjuvanted H5N1 candidate vaccine was highly immunogenic for A/Indonesia/05/2005, with cross-reactivity against A/Vietnam/1194/2004. Temporary injection site reactions were more frequent with H5N1 vaccine than placebo, although the H5N1 vaccine was well tolerated overall.Clinical Trials Registration. NCT00616928.