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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 influenza (influenza) virus lysed vaccine. Methods According to the principle of random sampling, a single center, open-ended, inoculated with a flu vaccine immunization method to carry out clinical trials. Results The observed incidence of local reactions was 0.6% after one dose of inoculation; the incidence of fever was 4.52%, with mild fever. The results of serological tests showed that the rates of total positive rotation (≥1: 40) of HAI antibodies of influenza A 1, A 3 and B subtypes were 95.0% and 87.1 % And 88.1%, respectively. The geometric mean titer (GMT) of HAI antibody was 33.28 times, 7.76 times and 26.04 times respectively. The antibody protection rates were 100.0%, 99.7% and 98.4%, respectively. The three types of antibody positive rate of rotation, GMT multiples, the protection rate differences were statistically significant. Conclusion Domestic influenza virus lytic vaccine is safe for ≥3 years old population with significant immunological effect.