口服霍乱WC-rBS疫苗胶囊的安全性和免疫原性研究

目的评价国产胶囊剂型、灭活霍乱全菌体（WC）与重组B亚单位（rBS）联合疫苗（WC-rBS）的安全性和免疫原性，比较水剂与胶囊剂型的免疫效果。方法选择74名志愿者，按随机分层分组分为胶囊剂组（32人WC1011CFU＋rBS1mg／人次）、水剂用（32人WC1011CFU＋rBS1mg／人次）及安慰剂组（10人）。结果和结论WC－rBS胶囊剂疫苗安全、服苗组未见任何不良反应；免疫原性好，粪抗CT、抗LPS和Vab阳转率分别为84．4％、90．6％和71．9％，血清抗CT、抗LPS和Vab阳转率分别为84．4％，78．1％，抗87．5％。

The study of safety and immunogenicity in humans by oral killed whole-cell/recombinant-B-subunit cholera vaccine of capsule

Objective To evaluate the safety and immunogenicity of the oral killed whole-cell/recombinant-B-subunit (WCrBS) cholera vaccine and to compare the safety and the immunogenicity of the capsule with the aqua of the vaccine. Method 74 volunteers were randomyly divided into 3 groups(capsule group 32,aqua group 32,placebo group lO). Each volunteers re ceived 3 doses of the oral vaccine(each time WC 1011 CFU+rBS 1 mg/person) or placebo. The safety and immunogenicity of WC-rBS were evaluated for side effects and average antibody leve. Results and Conclusions WC-rBS vaccine of vibrio cholera is safe and has active immunogenicity. Conversion rates of fecal anti-CT,anti-LPS and vibriocidal antibody were 84. 4%' 90.6% and 71. 9%. Conversion rates of serum anti-CT,anti-LPS and vibriocidal antibody were 84. 4%, 78. 1 %, 87. 5 % respectively.