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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、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.
In order to assess the safety, immunogenicity and the protective effect of the rBS-WC vaccine on the freeze-dried oral cholera, from July 1997 to July 1998, among the commanders and officers of the Guangzhou Military Region and the Nanjing Military Region, the rBS- Field trials of WC vaccines (capsule dosage forms). 6079 people were randomly divided into 3 groups. They were given high-dose vaccine (1mgrBS + 1 × 1011WC), low-dose vaccine (lmgrBS + 5 × 1010WC) and placebo by double-blind method. 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.