长生科技冻干水痘减毒活疫苗的安全性及免疫原性研究

Evaluation on safety and immunogenicity of Changshengkeji frozen-dried live attenuated varicella vaccine

目的：评价长生科技冻干水痘减毒活疫苗的安全性及免疫原性。方法：按随机、双盲的抽样原则，以国产同类疫苗作为对照，在江苏省涟水县720名1-12岁儿童中开展现场临床试验，比较两种疫苗免疫后临床反应率及抗体阳转率、保护率、几何平均滴度（GMT）。结果：所有受试者经试验疫苗免疫后，全身总发热反应率为8．33％，局部反应总反应率为2．08％；抗体GMT为1：52、23．抗体阳转或成功率为97.12％。试验组与对照组间全身反应、局部反应、免疫后抗体GMT、阳转率、免疫成功率及4倍增长率均无显著性差异。结论：长生科技冻干水痘减毒活水痘疫苗对受试人群具有较好的安全性和免疫原性。

Objective To evaluate the safety and immunogenicity of Changshengkeji frozen-dried live attenuated varicella vaccine. Methods A randomized, double-blind study was carried out in 720 children aged 1 - 12 years in Lianshui ,Jiangsu Province to compare the safety, seroconversion rates and geometric mean titer （GMT）increase of the testing vaccine vs domestic vaccine as control. Results After immunization, the systemic and local reaction rates of the testing vaccine were 8.33% and 2.08% respectively. The GMT of antibody of children was 1 ： 52.23, and the seroconversion rates or success rate was 97.12%. No significant statistical difference was found in the results between the two vaccines. Conclusion The safety and immunogenicity of Changshengkeji frozen-dried live attenuated varicella vaccine is as good as the same kind domestic vaccine.