甲、乙型肝炎联合疫苗在儿童中0、6月程序接种的安全性和免疫原性研究

目的 观察和评价在儿童中接种2剂倍尔来福~(TM)甲、乙型肝炎(分别简称为甲肝、乙肝)联合疫苗的安全性及免疫原性.方法 本研究以江苏省常州市116名1～10岁完成乙肝疫苗全程免疫同时无甲肝疫苗接种史的抗甲肝病毒抗体(anti-hepatitis A virus,抗-HAV)阴性儿童为研究对象,按0、6个月程序接种甲、乙肝联合疫苗(倍尔来福~(TM)).每剂疫苗0.5 ml,含HAV抗原250 U和乙肝表面抗原5μg.观察接种疫苗后72 h内局部反应和全身反应,检测免疫后1、6、7个月的血清抗-HAV阳转率、乙肝病毒表面抗体(抗-HBs)保护率及抗体滴度.结果 倍尔来福~(TM)接种后局部和全身不良反应发生率分别为12.1%(14/116)和6.0%(7/116),其中局部不良反应以注射部位红、肿、硬结为主,占6.9%(8/116)～11.2%(13/116),全身不良反应发生率为6.0%(7/116),以发热为主.免疫后1、6、7个月,抗.HAV阳转率为92.9%(92/99)～100.0%(101/101),抗体几何平均滴度(GMT)为47.0～2762.3 mIU/ml;疫苗免疫前抗-HBs阳性保护率为86.1%(87/101),免疫后1个月达到100.0%(101/101),免疫后1、6、7个月抗-HBs GMT为894.3～3314.3 mlU/ml.结论 倍尔来福~(TM)甲、乙肝联合疫苗2剂接种程序在乙肝基础免疫儿童中应用具有良好的安全性和免疫原性.

Safety and immunogenicity of combined hepatitis A and hepatitis B vaccine according to 0 and 6 months schedule in healthy children

Objective To evaluate the safety and immunagenieity of the Bilive~(TM) combined hepatitis A and hepatitis B vaccine in healthy children. Methods A total of 116 healthy children aged 1 - 10 years, who,without history of hepatitis A vaccine vaccination and anti-HAV negative, had completed the full immunization of hepatitis B vaccine were recruited in city of Changzhou in Jiangsu province. The Bilive~(TM) combined hepatitis A and hepatitis B vaccine was administered according to a two-dose schedule (0,6 months). The dosage was 250 U for hepatitis A antigen and 5 μg for hepatitis B surface antigen. The potential adverse effects were observed within 72 hours after vaccination. The serum samples were collected for the testing of anti-HAV and anti-HBs at month 1,6 and 7 after initial dose. Results The local and systemic adverse reactions after immunization were slight and temporary. The rates of local and systemic adverse reactions were 12. 1% (14/116) and 6. 0% (7/116). The sero-conversion rates of HAV were from 92. 9% (92/99) to 100. 0% (101/101) and the geometric mean titers (GMT) ranged from 47.0 mlU/ml to 2762. 3 mlU/ml 1,6,7 months after initial dose. The sero-protection rate of HBV was 86. 1% (87/101) before vaccination and came up to 100. 0% (101/101) one month after initial dose,and the GMTs of HBV were from 894. 3 mlU/mi to 3314. 3 mlU/mi 1,6, 7 months after initial dose. Conclusion The Bilive~(TM) combined hepatitis A and hepatitis B vaccine has good safety and immunagenicity in healthy children who had preexisting immunity to hepatitis B virus.