Madan Anuradha, Segall Nathan, Ferguson Murdo, Frenette Louise, Kroll Robin, Friel Damien, Soni Jyoti, Li Ping, Innis Bruce L, Schuind Anne
GSK, Collegeville.
Clinical Research Atlanta, Stockbridge, Georgia.
J Infect Dis. 2016 Dec 1;214(11):1717-1727. doi: 10.1093/infdis/jiw414. Epub 2016 Sep 7.
Almost 700 cases of human infection with avian influenza A/H7N9 have been reported since 2013. Pandemic preparedness strategies include H7N9 vaccine development.
We evaluated an inactivated H7N9 vaccine in an observer-blind study in healthy adults aged 18-64 years. Participants (420) were randomized to receive 1 of 4 AS03-adjuvanted vaccines (low or medium dose of hemagglutinin with AS03 or AS03), one nonadjuvanted vaccine, or placebo. The coprimary immunogenicity objective determined whether adjuvanted vaccines elicited an immune response against the vaccine-homologous virus, 21 days after the second vaccine dose per US and European licensure criteria in the per-protocol cohort (n = 389).
All adjuvanted vaccines met regulatory acceptance criteria. In groups receiving adjuvanted formulations, seroconversion rates were ≥85.7%, seroprotection rates ≥91.1%, and geometric mean titers ≥92.9% versus 23.2%, 28.6%, and 17.2 for the nonadjuvanted vaccine. The AS03 adjuvant enhanced immune response at antigen-sparing doses. Injection site pain occurred more frequently with adjuvanted vaccines (in ≤98.3% of vaccinees) than with the nonadjuvanted vaccine (40.7%) or placebo (20.0%). None of the 20 serious adverse events reported were related to vaccination.
Two doses of AS03-adjuvanted H7N9 vaccine were well tolerated and induced a robust antibody response at antigen-sparing doses in healthy adults.
NCT01999842.
自2013年以来，已报告近700例人类感染甲型H7N9禽流感病例。大流行防范策略包括研发H7N9疫苗。
我们在一项针对18至64岁健康成年人的观察者盲法研究中评估了一种灭活H7N9疫苗。420名参与者被随机分配接受4种含AS03佐剂疫苗（低剂量或中剂量血凝素与AS03或AS03组合）中的一种、一种无佐剂疫苗或安慰剂。共同主要免疫原性目标是根据美国和欧洲的许可标准，在符合方案队列（n = 389）中，确定在第二次接种疫苗21天后，含佐剂疫苗是否能引发针对疫苗同源病毒的免疫反应。
所有含佐剂疫苗均符合监管验收标准。在接受含佐剂制剂的组中，血清转化率≥85.7%，血清保护率≥91.1%，几何平均滴度≥92.9%，而无佐剂疫苗的相应比例分别为23.2%、28.6%和17.2%。AS03佐剂在抗原节约剂量下增强了免疫反应。与无佐剂疫苗（40.7%）或安慰剂（20.0%）相比，含佐剂疫苗注射部位疼痛的发生率更高（≤98.3%的接种者）。报告的20例严重不良事件均与疫苗接种无关。
两剂含AS03佐剂的H7N9疫苗耐受性良好，在健康成年人中以抗原节约剂量诱导了强烈的抗体反应。
NCT01999842。
