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目的考核和评价我国自行分离毒株研制的冻干水痘减毒活疫苗的安全性和免疫原性。方法采用随机、双盲、对照的原则进行设计,在2～6岁健康人群中进行开放式临床观察。结果试验疫苗共接种易感儿童738人,接种后的总体中强发热反应率为5.96%(44738),皮疹水痘样皮疹发生率为0.68%(5738);易感者接种39810PFU、2000PFU以及500PFU病毒量的疫苗后,抗体GMT分别为36.4、34.3和18.6;抗体阳转率分别为100%、98.77%和85.42%。结论我国自行研制的水痘疫苗具有较好的安全性和免疫原性。
Objective To evaluate and evaluate the safety and immunogenicity of live attenuated freeze-dried varicella vaccine developed by our country. Methods A randomized, double-blind, and control principle was designed and an open clinical observation was conducted in healthy population aged 2 ~ 6 years. Results A total of 738 susceptible children were challenged with the vaccine after vaccination. The overall incidence of moderate fever was 5.96% (44738) after vaccination, and the incidence of rash chickenpox-like rash was 0.68% (5738). Susceptible persons were challenged with 39810 PFU, 2000 PFU and 500 PFU virus After immunization, the antibody GMT was 36.4, 34.3 and 18.6, respectively. The antibody positive rates were 100%, 98.77% and 85.42% respectively. Conclusion Our self-developed chickenpox vaccine has good safety and immunogenicity.