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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 observe the safety and immunogenicity of the combination of Beleufloxera (TM) A and Hepatitis B (A and B) vaccines. Methods The students in first grade (adult group) and first grade to fifth grade (children group) in high school were selected as study subjects and were susceptible to both A and B viruses. Susceptible to Hepatitis A virus only and Susceptible to Hepatitis B virus only Group A, Group B and Group B received 0, 1, and 6 months of three doses of hepatitis A vaccine, inactivated hepatitis A vaccine and recombinant hepatitis B vaccine respectively. Vaccine dose Each adult dose of hepatitis A virus containing 500U and (or) HBsAg 10μg, children’s group halved. Side effects were observed within 72 hours after vaccination. Serum samples were collected 2 and 7 months after immunization to detect anti-HAV and anti-HBs. Results The incidence rates of side effects in children AB and adults AB were 0.58% (2/344) and 2.56% (8/312) respectively, and the rates of systemic side effects were 9.88% (34/344) and 5.45% (17% / 212), compared with the control group no significant difference. Local reactions are mainly mild pain, systemic reactions are mainly low fever. At 7 months after immunization, the positive rate of anti-HAV in both groups was 100%, which was the same as that in group A; the antibody titers (GMTs) were 33 910 mIU / ml and 23 435 mIU / ml, respectively, The positive rate of anti-HBs was 97.30% and 96.63% respectively. The GMT was 103 mIU / ml and 102 mIU / ml. The anti-HBs positive rate and GMT were not significantly different from those of group B. Conclusion The combination of Behrevel ~ (TM) A and B hepatitis B vaccine has the same safety and immunogenicity as monovalent hepatitis A vaccine and monovalent recombinant hepatitis B vaccine.