龙口市健康儿童甲乙型肝炎联合疫苗加强免疫效果评价

Assessment on Booster Immunization in Healthy Children with Inactivated Hepatitis A Vaccine and Hepatitis A and Hepatitis B Combined Vaccine

[目的]评价甲乙型肝炎联合疫苗一针加强免疫程序的免疫效果和安全性,为完善甲肝疫苗和乙肝疫苗免疫预防策略提供决策依据。[方法]选择210名24～38月龄儿童,随机分为2组:实验组接种1剂次甲乙肝联合疫苗,对照组接种1剂次甲肝灭活疫苗。免后1个月,采用定量微粒子酶联免疫法检测甲肝抗体,采用抗-HBs化学发光法检测乙肝抗体,评价免疫前后甲、乙肝抗体水平(GMC)和阳性率。并对受试者进行连续3d体温及可能发生的任何临床症状观察和随访,以评价其安全性。[结果]对照组(甲肝疫苗组)加强免疫1个月后甲肝抗体阳性率由免前的95.20%上升到100.00%,GMC增长倍数达55.74倍。实验组(甲乙联苗组)甲肝抗体阳性率由免前的88.80%上升到98.90%,GMC增长58.35倍。乙肝抗体阳性率由免前的的72.90%上升到97.80%,增长24.90%;GMC由免前的22.20mIU/ml上升到1 226.10mIU/ml,增长54.50倍。观察到12例不良反应,均为发热,发生率为5.74%,未发现其他不良反应。[结论]甲乙型肝炎联合疫苗进行加强免疫具有良好的免疫原性和安全性,建议增加1剂次甲乙联苗加强免疫程序,帮助接种者获得长期的甲肝、乙肝抗体保护。

[Objective]To assess the effectiveness and safety of the booster immunization with inactivated hepatitis A vaccine/hepatitis A and hepatitis B combined vaccine,in order to provide the basis for hepatitis A vaccine and hepatitis B vaccine immunization strategy. [Methods]A total of 210 children aged 24-38 months otd were divided into two groups. One group were vaccinated with inactivated hepatitis A vaccine and another group waere vaccinated with hepatitis A and hepatitis B combined vaccine. Serum samples were collected after one month and detected anti-HAs with ELISA, anti-HBs with CMIA in order to evaluate GMC and antibody positive rate before and after immunization. Body temperature and clinical symptom were observed for 3 three days in order to evaluate its safety. [Results] Hepatitis A antibody positive rate rose from 95.20% to 100.00% and CAV/C increased 55.74 times in Hepatitis A vaccine group. Hepatitis A antibody positive rate rose from 88.80% to 98.90% and GMC increased 58.35 times in another group. Hepatitis B antibody positive rate rose from 72.90% to 97.80% and GMC increased from 22.20 mIU/ ml to 1 226.10 mIU/ml which increased by 54.50 times. The effectiveness of booster immunization was very obvious. 12 cases were observed with adverse reactions and all were fever. The incidence was 5.74%. Severe adverse reaction was not found. [Conclusion]Inactivated hepatitis A vaccine and hepatitis A and hepatitis B combined vaccine have good immunogenicity and safety. It is recommended to increase a booster immunity to enhance long-term antibody protection.