Safety and Long-term Humoral Immune Response in Adults After Vaccination With an H1N1 2009 Pandemic Influenza Vaccine With or Without AS03 Adjuvant
Safety and Long-term Humoral Immune Response in Adults After Vaccination With an H1N1 2009 Pandemic Influenza Vaccine With or Without AS03 Adjuvant
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DOI：
10.1093/infdis/jir641
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发表时间：
2012-03-01
影响因子：
6.4
通讯作者：
Vaughn, David
中科院分区：
文献类型：
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作者：
Ferguson, Murdo;Risi, George;Vaughn, David
背景在这项研究（NCT 00985088）中，我们评估了2009年H1N1大流行性流感疫苗的不同制剂，其在有或没有AS 03（基于生育酚的水包油佐剂系统）的情况下递送各种病毒血凝素（HA）剂量。共有1340名年龄≥ 18岁的健康受试者被随机分配接受1或2剂含佐剂（3.75 μ g HA/AS 03（A）或1.9 μ g HA/AS 03（B））或无佐剂疫苗制剂。本文报告了每次给药后和第1次给药后6个月的安全性和免疫原性（通过血凝抑制[HI]试验）。接种后21天，单剂量的AS 03（A）佐剂化的3.75 μ g HA H1N1 2009在年龄为18264岁的受试者（血清保护率[SPR]，97.2%;血清转化率[SCR]，90.1%）以及年龄>64岁的受试者（SPR，91.1%; SCR，78.2%）中诱导最强的免疫应答。第1次给药后6个月，接受2剂含佐剂制剂或1剂含佐剂3.75 μ g HA制剂的受试者继续符合生物制品评价和研究中心以及人用药品委员会的所有标准。所有制剂均具有临床可接受的安全性。单剂量的3.75 μ g HA AS 03（A）佐剂化的H1N1 2009流感疫苗在两个年龄层（18264岁和>64岁）中具有高度免疫原性，诱导免疫应答的长期持续性，直到第1次剂量后至少6个月。
Background. In this study (NCT00985088) we evaluated different formulations of an H1N1 2009 pandemic influenza vaccine that deliver various viral hemagglutinin (HA) doses with or without AS03 (a tocopherol-based oil-in-water adjuvant system).Methods. A total of 1340 healthy subjects aged >= 18 years were randomized to receive 1 or 2 doses of an adjuvanted (3.75-mu g HA/AS03(A) or 1.9-mu g HA/AS03(B)) or nonadjuvanted vaccine formulation. Safety and immunogenicity (by hemagglutination-inhibition [HI] assay) after each dose and 6 months after dose 1 are reported here.Results. A single dose of AS03(A)-adjuvanted 3.75-mu g HA H1N1 2009 induced the strongest immune responses in subjects aged 18264 years (seroprotection rate [SPR], 97.2%; seroconversion rate [SCR], 90.1%) as well as in subjects aged >64 years (SPR, 91.1%; SCR, 78.2%) 21 days after vaccination. Six months after dose 1, subjects who received 2 doses of either the adjuvanted formulation or 1 dose of the adjuvanted 3.75-mu g HA formulation continued to meet all Center for Biologics Evaluation and Research and Committee for Medicinal Products for Human Use criteria. All formulations had clinically acceptable safety profiles.Conclusion. A single dose of the 3.75-mu g HA AS03(A)-adjuvanted H1N1 2009 influenza vaccine was highly immunogenic in both age strata (18264 and >64 years), inducing long-term persistence of the immune response until at least 6 months after dose 1.