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目的观察国产流感病毒亚单位疫苗的安全性及免疫原性。方法按照单盲法、随机、对照的原则,将900名观察对象分为幼儿组、儿童组、成人组和老年组,各组分别按2∶1的比例随机接种试验疫苗和对照疫苗(进口疫苗),观察各组接种后的全身反应、局部反应和其他不良反应以及免疫后HI抗体阳转率、保护率和GMT增长倍数。结果观察组接种后全身反应发生率为8.33%,仅1例发生局部反应,不同年龄人群全身反应发生率与对照组相比,差异均无统计学意义(P>0.05);免疫后观察组H1N1、H3N2和B(亚)型HI抗体总阳转率分别为87.90%、70.02%和71.32%,保护率分别为93.30%、93.30%和74.67%,与对照组相比,差异均无统计学意义(P>0.05);GMT增长倍数分别为31.6、8.2和14.0,除H1N1亚型GMT平均增长倍数高于对照组外,其他两(亚)型与对照组相比,差异无统计学意义(P>0.05)。结论国产流感病毒亚单位疫苗具有与进口同类疫苗相似的安全性和免疫原性。
Objective To observe the safety and immunogenicity of the domestic influenza virus subunit vaccine. Methods According to the principle of single-blind, randomized and controlled, 900 subjects were divided into preschool group, children group, adult group and elderly group. The groups were randomly inoculated with the test vaccine and the control vaccine according to the ratio of 2: 1 ), Observe the systemic reactions, local reactions and other adverse reactions after vaccination in each group as well as HI antibody positive rate of immunization, protection rate and multiplication of GMT. Results The incidence of systemic reaction in observation group after vaccination was 8.33%, only one case had local reaction. The incidence of systemic reaction in different age groups was not significantly different from that in control group (P> 0.05). After immunization, H1N1 , The total positive conversion rate of HI antibody of H3N2 and B (sub) type were 87.90%, 70.02% and 71.32% respectively, and the protection rates were 93.30%, 93.30% and 74.67% respectively, with no significant difference compared with the control group (P> 0.05). The growth multiples of GMT were 31.6, 8.2 and 14.0, respectively. Except H1N1 subtypes, the mean growth of GMT was higher than that of the control group, while the other two subtypes had no significant difference > 0.05). Conclusion The domestic influenza subunit vaccine has the similar safety and immunogenicity as the imported similar vaccine.