Thongcharoen Prasert, Auewarakul Prasert, Hutagalung Yanee, Ong Gary, Gillard Paul, Drame Mamadou, Bock Hans L
Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.
J Med Assoc Thai. 2011 Aug;94(8):916-26.
The present study (NCT00449670) in Asian subjects (18-60 years) evaluated the manufacturing consistency of four formulations of 3.75 mg AS03(A)-adjuvanted H5N1 influenza vaccine, in terms of post-immunization Hemagglutination Inhibition (HI) titers against the A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains. The immunogenicity and safety of the vaccine in the Thai population are reported herein.
Subjects were randomized (2:2:2:2.:1:1) between four vaccine groups and two control groups to receive two doses of either the AS03(A)-adjuvanted or non-adjuvanted H5N1 vaccine formulations, 21 days apart. Sera were assayed for HI antibody titers against the two strains.
After the second dose of AS03(A)-adjuvanted vaccine, 94.2% subjects in the H5N1-AS03(A) groups seroconverted and 94.9% subjects were seroprotected against the A/Vietnam/1194/2004 strain. Cross-clade immune response against the A/Indonesia/05/2005 strain was observed. All vaccine formulations had an acceptable safety profile.
This antigen-sparing AS03(A)-adjuvanted influenza vaccine could be a suitable candidate for combating and mitigating future influenza pandemics.
本研究（NCT00449670）针对亚洲受试者（18至60岁），根据免疫后针对A/越南/1194/2004和A/印度尼西亚/05/2005毒株的血凝抑制（HI）效价，评估了3.75毫克AS03（A）佐剂H5N1流感疫苗四种配方的生产一致性。本文报告了该疫苗在泰国人群中的免疫原性和安全性。
受试者被随机分配（2:2:2:2:1:1）至四个疫苗组和两个对照组，间隔21天接受两剂AS03（A）佐剂或非佐剂H5N1疫苗配方。检测血清针对两种毒株的HI抗体效价。
在接种第二剂AS03（A）佐剂疫苗后，H5N1-AS03（A）组中94.2%的受试者发生血清转化，94.9%的受试者对A/越南/1194/2004毒株具有血清保护作用。观察到针对A/印度尼西亚/05/2005毒株的跨分支免疫反应。所有疫苗配方的安全性均良好。
这种节省抗原的AS03（A）佐剂流感疫苗可能是应对和减轻未来流感大流行的合适候选疫苗。
