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。

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 d 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 rates in trial group during 3 d after each dose were 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 in cholera prophylaxis of the epidemic region for its better safety and short-term efficacy.