顶级期刊NEJM率先发表中国甲流疫苗成果文章

　　

生物通报道，中国不仅成为率先完成甲流疫苗临床试验国家，也成为首个发表甲流疫苗临床研究论文国家，10月21日，中国甲流疫苗研究性论文发表在国际权威期刊《New England Journal of Medicine》上，标题为：A Novel Influenza A(H1N1) Vaccine in Various Age Groups。

 

这篇“不同年龄组中甲型H1N1流感疫苗的临床观察”研究性论文由华兰生物疫苗有限公司研制和支持的，朱凤才教授主持的，由江苏省疾病预防控制中心、泰州疾病预防控制中心、中国药品生物制品检定所、中国疾病预防控制中心等单位共同完成。

 

该发表的文章，利用随机、双盲、对照临床试验对华兰生物公司研制的甲型H1N1流感裂解疫苗的安全性和免疫性进行了严格评估。试验观察对象是在3至77岁年龄人群，分四个年龄组。0、21天2针免疫，21天时为加强免疫。试验对象被接种安慰剂（PBS）或疫苗进行研究，疫苗分为无佐剂疫苗或添加氢氧化铝（AL(OH)3）佐剂的吸附疫苗，剂量为7.5 ug, 15ug 或30ug。在0、21天和35、42天时对血清样品进行分析。

 

 该临床试验有2200人接种了第一针，2103人（95.6%）接种了第二针疫苗或安慰剂。没有发现严重的不良反应。在无佐剂疫苗组，局部或系统性反应，大部分是轻微的，仅占总数的5.5%至15.9%。在接种15ug疫苗组，在3至11岁年龄组在21天74.5%的人HA滴定达到1：40或更高，12到17岁达到97.1%，在18到60岁达到97.1%，60岁以上达到79.1%；在35天滴度分别达到98.1%，100%，97.1%和93.3%。在接种30ug剂量组滴度达到1：40，无论是有佐剂组还是无佐剂组的血清转阳率、保护率与其他剂量组比较都是最高，且差异有统计学意义。不含佐剂疫苗有较少的局部反应和较大的免疫反应。这些数据显示15ug单剂量HA抗原不含氢氧化铝（AL(OH)3）佐剂能在12至60岁的大部分人群中诱导产生保护性免疫反应。

 

临床研究结果显示疫苗免疫原性结果均达到或超过欧盟及美国的标准，为全球甲型H1N1流感疫苗临床研究提供了宝贵的数据和借鉴。

（生物通 小茜）

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Published at www.nejm.org October 21, 2009 (10.1056/NEJMoa0908535) 

 

A Novel Influenza A (H1N1) Vaccine in Various Age Groups

 

Feng-Cai Zhu, M.D., Hua Wang, M.D., Han-Hua Fang, M.D., Jian Guo Yang, M.D., Xiao Jun Lin, M.D., Xiao-Feng Liang, M.D., Xue-Feng Zhang, M.D., Hong-Xing Pan, M.D., Fan-Yue Meng, M.D., Yue Mei Hu, M.D., Wen-Dong Liu, M.D., Chang-Gui Li, M.D., Wei Li, M.D., Xiang Zhang, M.D., Jin Mei Hu, M.D., Wei Bing Peng, M.D., Bao Ping Yang, M.D., Pei Xi, M.D., Hua-Qing Wang, M.D., and Jing-Shan Zheng, M.D.

 

Background There is an urgent need for a vaccine that is effective against the 2009 pandemic influenza A (H1N1) virus.

 

Methods A split-virus, inactivated candidate vaccine against the 2009 H1N1 virus was manufactured, and we evaluated its safety and immunogenicity in a randomized clinical trial. Subjects were between 3 and 77 years of age, stratified into four age groups. The immunization schedule consisted of two vaccinations, 21 days apart. Subjects were injected with placebo or with vaccine, with or without alum adjuvant, at doses of 7.5 µg, 15 µg, or 30 µg. Serologic analysis was performed at baseline and on days 21 and 35.

 

Results A total of 2200 subjects received one dose, and 2103 (95.6%) received the second dose, of vaccine or placebo. No severe adverse side effects associated with the vaccine were noted. In the nonadjuvanted-vaccine groups, injection-site or systemic reactions, most mild in nature, were noted in 5.5 to 15.9% of subjects. Among the subjects receiving 15 µg of nonadjuvanted vaccine, a hemagglutination-inhibition titer of 1:40 or more was achieved by day 21 in 74.5% of subjects between 3 and 11 years of age, 97.1% of subjects between 12 and 17 years, 97.1% of subjects between 18 and 60 years, and 79.1% of subjects 61 years of age or older; by day 35, the titer had been achieved in 98.1%, 100%, 97.1%, and 93.3% of subjects, respectively. The proportion with a titer of 1:40 or more was generally highest among the subjects receiving 30 µg of vaccine, with or without adjuvant. Vaccine without adjuvant was associated with fewer local reactions and greater immune responses than was vaccine with adjuvant.

 

Conclusions These data suggest that a single dose of 15 µg of hemagglutinin antigen without alum adjuvant induces a typically protective immune response in the majority of subjects between 12 and 60 years of age. Lesser immune responses were seen after a single dose of vaccine in younger and older subjects. (ClinicalTrials.gov number, NCT00975572 [ClinicalTrials.gov] .)