148名医务人员接种甲型H_1N_1流行性感冒病毒裂解灭活疫苗后的免疫原性和安全性分析

Analysis of immunogenicity and safety of inactivated split influenza A(H_1N_1) vaccine in 148 medical staff

目的:通过分析疫苗接种后的不良反应和检测疫苗接种前后血清抗体滴度,评估甲型H1N1流行性感冒(流感)病毒裂解灭活疫苗的安全性和免疫原性。方法:研究纳入148名医务人员,描述性分析疫苗接种后21 d内发生的不良反应并评估其严重程度;通过血凝抑制试验检测疫苗接种后血清抗体滴度。结果:该疫苗接种后绝大多数不良反应为轻、中度,未见严重不良反应事件。局部不良反应和全身不良反应发生率分别为19.1%和22.1%,接种部位疼痛和乏力是最常见的局部和全身不良反应。接种疫苗后21 d,血清抗体平均效价达1∶95.27[95%可信区间(CI):74.94～121.12)],101名接种者(82.1%,101/123)血清抗体滴度达到1∶40或高于1∶40,74.0%在疫苗接种后21 d血清抗体转阳。结论:对于成人甲型H1N1流感病毒裂解灭活疫苗可安全接种;绝大多数在接种后21 d血清抗体可转阳。

Objective To evaluate the immunogenicity and safety of an inactivated split influenza A（H1N1） vaccine manufactured in Shanghai. Methods A total of 148 subjects were enrolled in the study. The adverse events were recorded and analyzed descriptively. Antibody titers were measured by hemagglutinin-inhibition assay at baseline, 7 d and 21 d after vaccination. Results The vaccine was well tolerated and all the adverse events were mild to moderate in degree and no serious adverse event was observed. The incidences of local and systemic reactions were 19.1% and 22.1%, respectively. Injection-site pain and fatigue were the most commonly seen adverse events. By day 21 after vaccination, a hemagglutinin-inhibition antibody titers of 1：40 or mare were achieved in 101 of 123 （82.1%） subjects; the geometric mean titer （GMT） reached to 95.27 （95%CI, 74.94 to 121.12）, and 74.0% of subjects were turned to seropositive, Conclusions The inactivated split influenza A （H1N1） vaccine manufactured in Shanghai is safe and effective for adults, with mild to moderate adverse events and had a high seropositivity rate.