国产冻干水痘减毒活疫苗的安全性及免疫原性观察

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。

Safety and Immunogenicity of Lyophilized Live Attenuated Domestic Varicella Vaccine

Objective To evaluate the safety and immunogenicity of the lyophilized live attenuated domestic varicella vaccine of Oka strain in Zhejiang province. Methods 785 susceptible children aged 1-13 years, who had no history of VZV infection and had not been immunized, were observed. Results The results showed that 2.29% children had adverse reactions after 30mins of inoculation, 3.69% children had adverse reactions after 4 hours, 3.82% children had adverse reactions after 24 hours, 1.78% children had adverse reactions after 48 hours, 0.25% children had adverse reactions after 72 hours, no adverse reactions were observed after six weeks. There were 3.82% children had fever, The incidence rate of other adverse reactions such as swel 1 and scleroma were low. The vaccine had high sero-converson rate. Condusion The results showed that it has good safety and immunogenicity of the live attenuated domestic varicella vaccine.