【摘要】 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。更多还原

【Abstract】 Objective To evaluate the immunogenicity and safety of two types of domestic lytic influenza A((H1N1) virus vaccine in humans.Methods A randomized,double-blind,controlled clinical trial was conducted in 748 healthy volunteers aged 3 years and older.The subjects were divided into two trial groups and were inoculated with two different types of lytic vaccine(15 μg hemagglutinin/agent) at 0 and 21 day,respectively.Safety was evaluated by observing adverse reaction after inoculation.Serum hemagglutination inhibition(HI) antibody titers were tested at 0,21 and 42 day to determine their immunogenicity.Results At 21 and 42 day after the inoculation,the positive seroconversion rates of two different types of lytic vaccine were 81.39%,92.01% and 94.05%,95.80%.Antibody protective rates were 84.17%,95.36% and 96.88%,99.21%.The average increases of geometric mean titer in the two groups were 34.37,55.34 times and 43.69,57.20 times,respectively.Fever incidence rates of two groups were 9.44%,14.69% and 4.53%,2.36% after 30 minutes of inoculation.There were statistical significances in the indexes between two groups except for positive seroconversion rate and fever incidence rate at 42 day.Conclusion The two types of domestic lytic influenza A(H1N1) virus vaccine have good safety and immunogenicity.更多还原