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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6 079人随机分为3组,采用双盲法分别服用高剂量疫苗(1mg rBS+1×10~(11)WC),低剂量疫苗(1mg rBS+5×10~(10)WC)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。
To assess the safety, immunogenicity and protection of rBS-WC vaccines against lyophilized oral cholera. From July 1997 to July 1998, field trials of lyophilized oral cholera rBS-WC vaccine (capsule dosage form) were conducted among officers and soldiers in the Guangzhou Military Region, 6 079 were randomly assigned to 3 groups and were treated with double-blind Dose vaccine (1mg rBS + 1 × 10-11 WC), low dose vaccine (1mg rBS + 5 × 10-10 WC) and placebo. The vaccine side effects, the population’s antibody response, the incidence of acute diarrhea within six months after taking the vaccine, the protection rate of the toxin-producing Escherichia coli (ETEC) infection were tested. The results showed that the vaccine was safe and effective.