冻干甲型肝炎减毒活疫苗的接种反应及免疫原性观察

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。

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

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 min 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.