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目的观察国产冻干水痘减毒活疫苗(Varicella Attenuated Live Vaccine,Freeze-dried;VarV)的安全性及免疫原性。方法对未感染水痘-带状疱疹病毒、1～13岁健康儿童,接种国产VarV进行安全性观察,应用膜免疫荧光抗体方法检测水痘抗体。结果观察对象接种后30min和4h、24h、48h、72h的不良反应发生率,分别为2.29%、3.69%、3.82%、1.78%、0.25%,6周后无不良反应报告。总发热反应率为3.82%,注射部位红肿反应发生率为3.69%,局部硬结发生率为0.64%。VarV免疫后,免疫成功率为98.3%,免疫前、后抗体几何平均滴度增长明显。结论国产VarV临床反应轻微,安全性和免疫原性良好。
Objective To observe the safety and immunogenicity of Varicella Attenuated Live Vaccine (Freeze-dried; VarV). Methods The varicella - zoster virus (UV) and healthy children aged from 1 to 13 years old were inoculated with VarV, and the antibody was detected by immunofluorescent antibody. Results The incidence of adverse reactions in observation subjects at 30 minutes and 4 hours, 24 hours, 48 hours and 72 hours after inoculation were 2.29%, 3.69%, 3.82%, 1.78% and 0.25% respectively. There was no adverse reaction after 6 weeks. The total fever response rate was 3.82%, the incidence of inflamed reaction at injection site was 3.69%, and the incidence of local induration was 0.64%. The immune success rate was 98.3% after immunization with VarV. The geometric mean titers of antibodies increased obviously before and after immunization. Conclusion Domestic VarV has mild clinical response, good safety and immunogenicity.