人群口服霍乱rBS／WC疫苗的安全性及免疫效果评价  

The safety and immunological effect of oral cholera rBS/WC vaccine in rural villagers

作　　者：陈恩富[1] 吕华坤[2] 张鑫培[3] 章兴祥[4] 贾杰[5] 韦余东[6] 余昭[2] 秦淑文[2] 莫顺堂[2] 

机构地区：[1]浙江省疾病预防控制中心免疫预防所,杭州310051 [2]浙江省疾病预防控制中心传染病防制所,杭州310051 [3]上虞市疾病预防控制中心办公室,312300 [4]上虞市疾病预防控制中心传染病防制科,312300 [5]上虞市疾病预防控制中心微生物检验科,312300 [6]浙江省疾病预防控制中心办公室,杭州310051

出　　处：《国际生物制品学杂志》2009年第2期79-82,共4页International Journal of Biologicals

摘　　要：目的进一步观察自然人群口服重组霍乱毒素B亚单位／灭活霍乱弧菌全菌体疫苗的安全性和免疫学效果，为制定霍乱免疫预防策略提供依据。方法采用随机、双盲、对照试验，随访观察每次服苗后3d内以及全程服苗后1、2、3月的不良反应，按比例随机抽取试验组和对照组受试者采血，用酶联免疫法检测抗霍乱毒素抗体，采用SPSS软件对数据进行相关分析。结果每次服苗后3d内试验组的总不良反应率为1．16％，主要是轻微胃肠道反应；试验组抗霍乱毒素抗体，全程接种后1～6月维持较高的阳性率，全程接种后12月有所降低。结论口服霍乱疫苗具有良好的安全性和短期效果，可用于流行区的霍乱免疫预防。Objective To further evaluate the safety and immunological effect of oral cholera rBS/WC vaccince and provide evidence for cholera immunoprophylaxis strategy. Methods A randomized, doubleblind and controlled trial was conducted to surveil the adverse reactions during 3 days after each dose and 1- ,2- and 3-month after full course vaccination. The subjects in trial group and control group were randomly sampled in proportion to collect blood and the serum anti-cholera toxin IgG was tested by ELISA. Data were analysed with SPSS software. Results The total adverse reaction rate in trial group during 3 days after each dose was 1.16%, the adverse reactions were mainly mild gastrointestinal symptoms. The positive rate of serum antibody to cholera toxin in trial group was remained higher during 6 months after full course vaccination and fell slowly 12 months after the last dose. Conclusion Oral cholera rBS/WC vaccine can be used for cholera prophylaxis in endemic regions for its better safety and short-term efficacy.

关 键 词：霍乱 口服疫苗 安全 抗体 

分 类 号：R1[医药卫生—公共卫生与预防医学]