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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 A (H1N1) influenza virus lytic vaccine. Methods According to the principle of randomized, controlled and blinded, the program of 0,21 days was selected from 220 sen, 220 juvenile and 220 juvenile infants respectively, and randomly assigned to receive 15 μg and 30 μg of Influenza A (H1N1) influenza vaccine in a ratio of 1: 1: 1: 1 ratio of 15μg, 30μg of influenza A H1N1 influenza vaccine and placebo control (PBS); 0,28 d routine selection of only 220 adult group, according to a 1: 1 ratio of random inoculation 15μg, 30μg influenza A H1N1 influenza vaccine . The adverse reaction rate, systemic and local adverse reaction rate, immunization HI antibody positive rate, protection rate, GMT level and average multiplication rate were observed. Results The overall incidence of adverse reactions in 1210 subjects was 21.82%, which were all grade 1 adverse reactions. No grade 3 or grade 3 adverse reactions, other abnormal reactions and serious adverse events were observed. HI antibody positive rate and protection rate of 30μg dose group after immunization compared with 15μg dose group, the difference was not statistically significant. The two vaccination programs in the same dose group after the first needle immunization HI antibody positive rate, protection, immunization GMT and growth multiple indicators of each index, the difference was not statistically significant. Conclusion The domestic A (H1N1) influenza virus lytic vaccine has good safety and immunogenicity. According to the 0 and 21d programs, each vaccine of 1μg 15μg H1N1 influenza vaccine can produce good immune effect in 12 ~ 60 years old population.