大学生与务工人员服用口服重组B亚单位霍乱疫苗的安全性及效果分析

目的 评价北京奥运志愿者和奥运工地务工人员在服用国产口服重组B亚单位/菌体霍乱菌苗(可唯适)后的不良反应、免疫和流行病学效果.方法 2008年6月,观察大学奥运志愿者服苗后不良反应发生率及疫苗保护率;用ELISA法检测2个奥运工地的务工人员服苗前后不同时间抗霍乱毒素抗体(CT抗体),比较阳转率及抗体持久性.结果 大学志愿者服苗后的总不良反应率为0.38%;不良反应主要是腹痛、腹泻等,均为轻度-过性反应;服苗志愿者急性腹泻发病率明显低于未服苗的志愿者,该疫苗的保护率是76.27%;务工人员服苗后抗CT抗体阳转率明显高于服苗前,服苗6个月后抗体水平有所下降.结论 国产口服重组B亚单位霍乱疫苗在志愿者、务工人员中服用,有较好的安全性、免疫原性及群体保护效果.

Analysis of safety and effects on the oral whole cell/recombinant B subunit cholera vaccine in university students and workers

Objective To evaluate the safety, immunogenicity and protective efficiency of the oral whole cell/recombinant B subunit cholera vaccine in Beijing Olympic volunteers and workers. Method Analyzing the incidence rate of adverse reaction and Protective Rate (PR) after taking the vaccine in Olympic volunteers in 6 universities in Beijing; comparing the anti-cholera toxin(CT) detected with ELISA prior and after taking the vaccine in Olympic workers. Results The total rate of adverse reaction of Olympic volunteers was 0. 38% ; the main side effects were gastrointestinal symptoms ,such as bellyache and diarrhea which were mild and temple; the acute diarrhea incidence rate of Olympic volunteers after taking the vaccine was significantly lower than those not taking it ,the PR was 76. 27% ;the positive rate of anti-CT of Olympic workers after taking the vaccine was significantly higher than those before taking it, the levels of anti-CT titers declined after 6 months since they had taken the vaccine. Conclusion The results from above two observed population indicate that the oral rBS-WC cholera vaccine is efficient and safe.