流行性感冒病毒裂解疫苗安全性与免疫原性研究

Evaluation on the Safety and Immunogenicity of Split Influenza Virus Vaccine

目的评价流行性感冒(流感)病毒裂解疫苗的安全性和免疫原性。方法按随机抽样原则,采用单一中心、开放式、接种1剂流感病毒裂解疫苗免疫的方法,开展临床试验。结果观察对象接种1剂后局部反应发生率为0.6%;发热反应发生率4.52%,且以轻度发热为主。血清学检测结果表明,接种疫苗后,流感病毒甲1、甲3、乙(亚)型的血凝抑制(Haemagglutination Inhibition,HAI)抗体总阳转(≥1:40)率分别为95.0%、87.1%、88.1%;HAI抗体几何平均滴度(Geometric Mean Titer,GMT)增长倍数分别为33.28倍、7.76倍、26.04倍;抗体保护率分别为100.0%、99.7%、98.4%。三个型别之间抗体阳转率、GMT增长倍数、保护率的差异有显著的统计学意义。结论国产流感病毒裂解疫苗应用于≥3岁人群是安全的,免疫效果显著。

Objective To evaluate the safety and immunogenicity of split influenza virus vaccine made in changchun institute of biological products. Methods Cluster samples were selected by random to carry out the single center, open clinical trial. Results After one dose injection, the rate of local reaction were 0.6%, and fever rate was 4.52%. The majority of the people with fever were mild fever. The HI Antibody positive rate of Influenza H1N1, H3N2, and B type were 94.98%, 87.1% and 88.1%; Geometric mean titer （GMT） of the three types antibody increased 104.79, 69.97 and 40.83 times respectively. The antibody protective rate were 100%, 99.7%, and 98.4% respectively. There were statistical difference on the HI antibody positive rate, times of GMT increased, and the antibody protective rate among the three types of influenza vaccine. Conclusion It is safety of split influenza virus vaccine for the people who are ≥ 3 years old, which made in changchun institute of biological products, and with good immunogenicity.