国产甲型H1N1流感病毒裂解疫苗的安全性及免疫原性

Safety and Immunogenicity of Domestic Influenza A H1N1 Virus Cleavage Vaccine

目的观察国产甲型H1N1流感病毒裂解疫苗的安全性及免疫原性。方法按照随机、对照、盲法的原则,0、21d程序选择老年组、少年组和少儿组各220人,按1︰1比例随机接种15μg、30μg甲型H1N1流感疫苗;成年组330人,按1︰1︰1比例随机接种15μg、30μg甲型H1N1流感疫苗和安慰剂对照(PBS);0、28d程序只选择成年组220人,按1︰1比例随机接种15μg、30μg甲型H1N1流感疫苗。观察各组接种后的总体不良反应率、全身和局部不良反应率以及免疫后HI抗体阳转率、保护率、GMT水平和平均增长倍数。结果1210名观察对象总体不良反应发生率为21.82%,均以1级不良反应为主,未观察到3级及3级以上不良反应、其他异常反应和严重不良事件。30μg剂量组免疫后HI抗体阳转率和保护率与15μg剂量组比较,差异无统计学意义。两接种程序同一剂量组内第1针免疫后HI抗体阳转率、保护率、免疫后GMT及增长倍数各指标比较,差异均无统计学意义。结论国产甲型H1N1流感病毒裂解疫苗具有良好的安全性和免疫原性,按照0、21d程序各接种1针15μg甲型H1N1流感疫苗,即可在12～60岁人群中产生良好的免疫效果。

Objective To observe the safety and immunogenicity of domestic influenza A H1N1 virus cleavage vaccine.Methods A clinical trial was performed according to a random,control and blind principle.Each of the aged,adolescent and children groups consisted of 220 subjects of whom 110 were inoculated with 15 μg of influenza A H1N1 virus cleavage vaccine and the other 110 with 30 μg,for 2 times by a schedule of 0 and 21 d.Adult group consisted of 330 subjects of whom 110 were inoculated with 15 μg of influenza A H1N1 virus cleavage vaccine,110 with 30 μg,and 110 with placebo,for 2 times by a schedule of 0 and 21 d.Another 220 adults were inoculated with 15 and 30 μg of influenza A H1N1 virus cleavage vaccine,110 for each,by a schedule of 0 and 28 d.The total,systemic and local adverse rates,HI antibody positive conversion rates,protective rates as well as GMT level and increasing folds of HI antibody in various groups after inoculation were observed.Results The total adverse reaction rate of the 1210 subjects was 21.8%,most of which were of degree 1,no adverse reactions of degree 3 or above,other abnormal reactions or severe adverse events were observed.The HI antibody positive conversion rate and protective rate induced by 30 μg of vaccine showed no significant difference with those induced by 15 μg.No significant differences were observed in the HI antibody positive conversion rate,protective rate,GMT levels and increasing folds after inoculation with the first dose of vaccine at the same dosage by different schedule.Conclusion Domestic influenza A H1N1 virus cleavage vaccine showed good safety and immunogenicity.The inoculation with one dose of 15 μg vaccine by a schedule of 0 and 21 d induced satisfactory immune effect in the population aged 12 ～ 60 years.