倍尔来福^(TM)甲、乙型肝炎联合疫苗安全性和免疫原性研究

Safety and immunogenicity of Bilive^(TM) combined hepatitis A and B vaccine

目的 观察倍尔来福^(TM)甲、乙型肝炎(甲、乙肝)联合疫苗的安全性和免疫原性。方法以高中一年级(成人组)和小学1～5年级(儿童组)学生为研究对象,按对甲、乙肝病毒均易感、只对甲肝病毒易感和只对乙肝病毒易感分为AB组、A组和B组,按0、1和6个月三剂程序分别接种甲、乙肝联合疫苗、灭活甲肝疫苗和重组乙肝疫苗。疫苗剂量成人组每剂含甲肝病毒抗原500U和(或)HBsAg10μg,儿童组减半。疫苗接种后72h内观察副反应,免疫后2、7个月采集血清标本检测抗-HAV和抗-HBs。结果 儿童AB组和成人AB组局部副反应发生率分别为0.58％(2/344)和2.56％(8/312),全身副反应发生率分别为9.88％(34/344)和5.45％(17/212),与对照组相比差异无显著性。局部反应主要是轻度疼痛,全身反应主要是低热。免疫后7个月,两组抗-HAV阳转率均为100％,与A组相同;抗体滴度(GMT)分别为33 910mIU/ml和23 435 mIU/ml,显著高于A组;两组抗-HBs阳转率分别为97.30％和96.63％;GMT为103 mIU/ml和102 mIU/ml,抗-HBs阳转率及GMT均与B组差异无显著性。结论 倍尔来福^(TM)甲、乙肝联合疫苗与单价甲肝灭活疫苗和单价重组乙肝疫苗具有相同的安全性和免疫原性。

Objective To study the safety and immunogenicity of the Bilive^(TM) combined hepatitis A and B vaccine produced by Sinovac Biotech Co., Ltd. Methods Samples were selected from first year students of a senior high school (adults group) and first to fifth grade 1-5 students of 3 primary schools (children group). Those who were susceptible to boeth hepatitis A virus (HAV) and heptitis B virus (HBV), HAV only or HBV only were assigned to group AB, A and B respectively and were vaccinated with threc doses (0, 1 and 6 month schedule) of Bilive^(TM) comined hepatitis A and B vaccine, inactivated hepatitis A vaccine and recombined hepatitis B vaccine respectively. The dosage for adult group was 500 U hepatitis A antigen and/or 10 μg hepatitis B surface antigen and the hae for children group was half the dosage of adult group The poential adverse effects wee observed within 72 hours after vaccination. Serum samples were collected for testing anti-HAV and anti-HBs at month 2 and 7 after the initial dose. Results The rates of local adverse effects were 0. 58% and 2. 56% in children AB group and adults AB group and the general adverse effects rates wer 9. 88% and 5. 45 % respectively. Both local and general adverse effect rates were not significantly different to the control group. The sero-conversion rate of anti-HAV in children and adults AB group reached 100%,one month after 3 doses. The geometric mean titer (GMTs) reached 33 910 mIU/ml and 23 435 mIU/ml respectively,significant higher than that in control group (group A). The sero-conversion rates of anti-HBs were 97. 30% and 96. 63%, and GMTs were 103 mIU/ml and 102 mIU/ml in children and adults AB group respectively. No significant difference on sero-conversior and GMT was observed when compared with control group' Conclusion The Belive^(TM) combined hepatitis A and B vaccine had good safety profile, and the immunogenicity both on anti-HAV and anti-HBs was similar to that of separated components.