国产大流行流感疫苗Ⅰ期临床试验安全性评价

Evaluation on safety of domestic pandemic influenza vaccine among healthy adults in phase Ⅰ clinical trials

目的对国产大流行流感裂解疫苗进行Ⅰ期临床试验研究,观察其安全性。方法采用单中心、随机、双盲安慰剂对照设计,在16-60周岁健康成人中按1：1：1：1比例设流感疫苗7.5,15.0,30.0μg及安慰剂对照等4个试验组,分别在0,21 d肌内注射疫苗。结果在临床试验观察和随访期间未发现其他异常反应、偶合反应和任何有临床意义的严重不良事件。各组不良反应以1级局部反应为主,反应多在48 h内痊愈。3个剂量组不良反应发生率明显高于安慰剂对照组（χ^2=25.282 5,P〈0.0001）。30.0μg组局部和全身反应发生率最高,分别占78.79%和51.52%。第1针接种后反应发生率高出第2针100.00%。结论大流行流感裂解疫苗有较好的安全性,无3级及以上不良反应发生。

Objective To conduct a phase Ⅰ clinical trial for pandemic influenza split-virion vaccine H5N1 and to assess the safety of the vaccine.Methods We conducted a single center,stratified-random,double-blind,placebo-controlled trial involving healthy adults aged 16 to 60 years who were assigned in a 1：1：1：1 ratio to receive two doses schedule（administered on days 0 and 21） of placebo（n=33） or an inactivated split-virion influenza A（H5N1） vaccine with 7.50 μg（n=33）,15.0 μg（n=33）,30.0 μg（n=33）.Results In the stage of clinical trial and follow-up, no abnormal reaction,coupiing reaction and any clinical significant serious adverse event was reported. Most of the reactions in all vaccine formulations were Ⅰ grade local reactions recovered within 48 hours. Reactions in treatment group were significantly higher than that of in placebo control group（χ^2 =25. 2825 ,P〈0. 0001 ）, The local and the systemic reaction rate of the group with 30.0 p,g dose was the highest（78. 79% and 51.52% ）. Reaction rate was 100% higher for the first dose than that of the second. Condusion Pandemic influenza split-virion vaccine had better security, no grade Ⅲ and above of adverse reaction occured.