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目的评价1~6岁儿童接种单剂冻干水痘减毒活疫苗的安全性及免疫原性。方法选择符合试验条件的351名1~6岁儿童接种冻干水痘减毒活疫苗,并于接种前和接种后6周分别采血1次,采用膜抗原荧光抗体法(FAMA)检测水痘病毒抗体。统计接种后不良事件发生率及抗体阳转率。结果接种水痘疫苗后10 d内共收集166例次不良事件,其中征集性不良事件26例次,发生率为7.41%;其余140例次为腹泻、感冒等非征集性不良事件,发生率为39.88%。易感人群(免疫前抗体滴度<1∶4)160人,在接种水痘疫苗6周后抗体几何平均效价(GMT)为125.80,抗体阳转率为100.00%;非易感人群(免疫前抗体滴度≥1∶8)166人,免疫后抗体GMT为200.93,抗体阳转率为100.00%。结论冻干水痘减毒活疫苗对1~6岁儿童具有良好的安全性和免疫原性。
Objective To evaluate the safety and immunogenicity of single attenuated live attenuated vaccines for children aged 1 ~ 6 years. Methods A total of 351 children aged 1 to 6 years were selected to receive live attenuated attenuated vaccine of freeze-dried varicella. The blood samples were collected one time before vaccination and six weeks after inoculation. Antibody varicella virus was detected by FAMA. Statistics incidence of adverse events and antibody positive rate of vaccination. Results A total of 166 adverse events were collected within 10 days after inoculation of varicella vaccine, of which 26 cases were collected for adverse events, the incidence rate was 7.41%. The remaining 140 cases were non-collection-induced adverse events such as diarrhea and cold, with an incidence rate of 39.88 %. The susceptible population (pre-immune antibody titers <1: 4) were 160, the geometric mean antibody titer (GMT) was 125.80 after 6 weeks of vaccination, and the positive rate of antibody positive was 100.00%. In non-susceptible population Antibody titer≥1: 8) 166 people, after immunization antibody GMT was 200.93, antibody positive rate was 100.00%. Conclusion The freeze-dried varicella live attenuated vaccine has good safety and immunogenicity for children aged 1 to 6 years.