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目的评价2种国产新型甲型H1N1流感病毒裂解疫苗的免疫原性与安全性。方法采用随机、双盲、对照方法,选取≥3岁健康志愿者748人,分为2组,分别于0、21 d接种甲、乙2种不同疫苗,剂量均为15μg血凝素/剂,并分别测定比较0、21和42 d的抗体阳转率、疫苗保护率和血清H I抗体滴度,判定其免疫原性;观察比较接种后不良反应率,评价其安全性。结果甲、乙2种疫苗免疫后21、42 d抗体阳转率分别为81.39%、92.01%和94.05%、95.80%,抗体保护率分别为84.17%、95.36%和96.88%、99.21%,几何平均滴度(GMT)增长倍数分别为34.37、55.34倍和43.69、57.20倍;疫苗接种后30 m in内,发热发生率分别为9.44%、14.69%和4.53%、2.36%;除42 d抗体阳转率和发热发生率外,其余各指标在2种疫苗间的差异均有统计学意义。结论甲、乙2种疫苗均具有良好的免疫原性和安全性。
Objective To evaluate the immunogenicity and safety of two domestic new type A H1N1 influenza virus lytic vaccines. Methods A total of 748 healthy volunteers aged 3 or older were selected as randomized, double-blind and control methods and divided into two groups. Two different vaccines, A and B, were inoculated on days 0 and 21 respectively at doses of 15 μg hemagglutinin / The antibody positive rate, vaccine protection rate and serum HI antibody titers at 0, 21 and 42 d were measured respectively to determine their immunogenicity. The adverse reaction rate after inoculation was observed and compared to evaluate the safety. Results The antibody positive rates of antibody A and B were 81.39%, 92.01% and 94.05%, 95.80% respectively at 21 and 42 d after immunization. The antibody protection rates were 84.17%, 95.36%, 96.88% and 99.21% respectively. The geometric mean The multiples of GMT were 34.37, 55.34 and 43.69, 5.20 times respectively. The incidence of fever was 9.44%, 14.69% and 4.53%, 2.36% within 30 min after vaccination, respectively. Rate and incidence of fever, the remaining indicators in the two vaccines were statistically significant differences. Conclusion Both A and B vaccines have good immunogenicity and safety.