冻干甲型肝炎减毒活疫苗的接种反应及免疫原性观察

Adverse Reaction and Immunogenicity Induced by Freeze-dried Live Attenuated Hepatitis A Vaccine

目的观察冻干甲型肝炎减毒活疫苗的接种反应和免疫原性。方法采用随机、开放式试验设计,选择出生后未接种过甲肝疫苗的18月龄以上的儿童和18～35周岁的成人,接种冻干甲肝减毒活疫苗1针。接种后30min观察即时反应,24、48和72h进行局部和全身反应观察,免后30d采血,分离血清,进行免疫原性检测。结果562名观察对象接种疫苗后均未发生局部反应,全身反应仅表现为轻度发热,有35人次(6.23%)发生发热反应。471名完成免疫原性检测的观察对象免后抗-HAV阳性率为99.8%,保护性抗体阳性率为96.4%,抗-HAVGMC水平为527.4mIU/ml,较免前增长30.3倍。儿童组和成人组免后保护性抗体阳性率分别为97.0%和95.9%,抗-HAVGMC水平分别为84.1和2119.1mIU/ml。2组免前免后抗体阳性率和GMC水平差异均有统计学意义。277名易感者免后抗体阳性率为99.6%,保护性抗体阳性率为93.9%,GMC水平为92.6mIU/ml,儿童组免后抗体阳性率明显高于成人组,免后抗-HAVGMC水平则明显低于成人组,2组之间免后抗体阳性率和GMC水平差异均有统计学意义。结论国产冻干甲型肝炎减毒活疫苗接种后副反应轻微,免疫原性良好,适于推广应用。

Objective To observe the adverse reaction and immunogenicity induced by freeze-dried live attenuated hepatitis A （HA） vaccine. Methods A random and open clinical trial was performed in children at more than 18 months of age, who were uninoculated with HA vaccine, and adults at 18 - 35 years of age in Yancheng City, Jiangsu Province, China. All the subjects were inoculated with a single dose of freeze-dried live attenuated HA vaccine and observed for immediate reactions within 30 rain as well as local and systemic reactions 24, 48 and 72 h after inoculation. The serum samples were collected 30 d after inoculation for evaluation of immunogenicity. Results No local reactions were observed in all the 562 subjects, while mild fever in 35 subjects （6. 23%）. Of the 471 subjects observed for immunogenicity of vaccine, the positive rates of anti-HAV and protective antibody were 99. 8% and 96.4% respectively, and the GMC of anti-HAV was 527. 4 mIU / ml, which increased by 30. 3 folds compared with that before immunization. The positive rate of protective antibodies in children and adults after immunization were 97. 0% and 95. 9%, while the GMCs of anti-HAV were 84. 1 and 2 119.1 mIU/ml, respectively, which showed significant difference with those before immunization. The positive rates of anti-HAV and protective antibody and GMCs of anti-HAV of 277 susceptible subjects after immunization were 99. 6%, 93.9% and 92. 6 mIU/ml respectively. However, the antibody positive rate of susceptible children after immunization was significantly higher, while the GMC of anti-HAV was significantly lower than that of susceptible adults. Conclusion Domestic freeze-dried live attenuated HA vaccine induced mild adverse reaction but good immunogenicity, which was worthy of popularization.