摘要
为考核冻干口服霍乱rBS-WC疫苗的安全性、免疫原性和对人群的保护效果，1997年7月～1998年7月在广州军区、南京军区指战员中，进行了冻干口服霍乱rBS-WC疫苗（胶囊剂型）的现场试验．将6079人随机分为3组，采用双盲法分别服用高剂量疫苗（1mgrBS＋1×1011WC）、低剂量疫苗（lmgrBS＋5×1010WC）及安慰剂．从疫苗的副作用、人群的抗体反应、服苗后半年内急性腹泻病的发病率、对产毒性大肠杆菌（ETEC）感染的保护率等方面进行了考核，结果表明该疫苗安全、有效．
6 079 volunteers of the field divisions of Guangzhou Military Area in GUangdong andNaming Military Aica in Fujian were subjected to receive field trail for the evaluation of thedomestically produced lyophilized recombinant B-subunit, inactivated whole Cell vaccine of vibriocholera (rBS -WC) from July 1997 to July 1998. Observing with double-blind method, the volunteerswere randomly divided into the groups, one was with high dose of vaccine (1mg rBS and 1 ×1011WC), the second was with low dose of vaccine (1mg rBS and 5 × 1010WC), and the third wasthe control with placebo. The safety, immunogenicity,and protective efficiency of lyopilized rBS-WC were evaluated through side effects, average antibody response,incidence of diarrhea andthe protective effichacy against ETEC infusion, etc. The field trial indicated that rBS -WC vaccineof vibrio cholela is efficient and safe.
出处
《中国计划免疫》
1999年第4期210-214,共5页
Chinese Journal of Vaccines and Immunization
基金
国家863计划资助
