Immunogenicity and tolerability of an AS03A-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults
Immunogenicity and tolerability of an AS03A-adjuvanted prepandemic influenza vaccine: A phase III study in a large population of Asian adults
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DOI：
10.1016/j.vaccine.2009.07.102
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发表时间：
2009-12-09
期刊：
影响因子：
5.5
通讯作者：
Ballou, Ripley W.
中科院分区：
文献类型：
--
作者：
Chu, Daniel Wai-Sing;Hwang, Shinn-Jang;Ballou, Ripley W.
在1206名亚洲成年人中评估了as03佐剂H5N1疫苗的免疫原性和批次间一致性，这些成年人随机接受两剂佐剂（3.75 μ g血凝素）或稀释剂混合疫苗，间隔21天。接种2剂后，H5N1-AS03组中96.0%的疫苗接种者对疫苗株a/ Vietnam/1194/2004的中和抗体滴度增加了4倍，对病毒株a/ Indonesia/0512005的中和抗体滴度增加了91.4%。检测到A/Vietnam/1194/2004和A/Indonesia/05/2005毒株的血凝抑制抗体（滴度>= 1:40）分别为94.3%和50.2%。证实了as03佐剂疫苗组合的批对批一致性。as03佐剂疫苗耐受性良好，诱导对疫苗株的高频率免疫应答，允许抗原保留并促进跨进化免疫。这些特点使它适合在认为即将发生H5N1大流行时推定使用。2009爱思唯尔有限公司版权所有。
The immunogenicity and lot-to-lot consistency of an AS03-adjuvanted H5N1 vaccine were evaluated in 1206 Asian adults, randomised to receive two doses of adjuvanted (3.75 mu g haemagglutinin) or diluent-mixed vaccines, 21 days apart. Post-Dose 2, 96.0% of vaccinees in the H5N1-AS03 group demonstrated a four-fold increase in neutralising antibody titres against the vaccine strain A/Vietnam/1194/2004 and 91.4% against strain A/Indonesia/0512005. Haemagglutination-inhibiting antibodies (titre >= 1:40) against A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains were observed in 94.3% and 50.2% of subjects, respectively. Lot-to-lot consistency of the AS03-adjuvanted vaccine combinations was demonstrated. The AS03-adjuvanted vaccine was well tolerated, induced a high frequency of immune responses to the vaccine strain, allowed antigen sparing and promoted cross-clade immunity. These characteristics make it suitable for presumptive use if an H5N1 pandemic were considered to be imminent. (C) 2009 Elsevier Ltd. All rights reserved.