人群口服霍乱rBS/WC疫苗的安全性及免疫效果评价

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3 d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3 d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.

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

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,double blind 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.