健康幼儿甲型肝炎灭活疫苗及甲乙型肝炎联合灭活疫苗再免疫血清学效果及安全性研究

目的评价甲型肝炎（甲肝）灭活疫苗（Hepatitis A Vaccine，Inactivated；HepA—I）和甲乙型肝炎联合灭活疫苗（Hepatitis A and B Combined Vaccine，Inactivated；HepAB—I）一剂再免疫的血清学效果和安全性。方法采用开放式临床研究设计，选择210名已经完成乙型肝炎（乙肝）疫苗（Hepatitis B Vaccine，HepB）全程免疫、且接种甲肝减毒活疫苗（Hepatitis A Attenuated Live Vaccine，HepA-L）≥6个月的24-38月龄儿童，分为2个试验组，分别接种1剂HepA—J和HepAB—I，并在免疫前和免疫后1个月，对受试者采血检测抗甲肝病毒抗体（Antibodyto Hepatitis A Virus，Anti—HAV）与抗乙肝病毒表面抗原抗体（Antibodvto Hepatitis B Virtus Surface Antigen，Anti-HBs），并对受试者连续3d测体温，并观察可能发生的任何临床症状和随访，以评价两种疫苗的安全性。结果HepA—I组受试者再免疫1个月后，Anti—HAV阳性[≥20毫国际单位（mIU）／毫升（ml）]率由免疫前的95．1％上升到100．0％，几何平均浓度（Geometric Mean Concentration，GMC）由免疫前的124．41mIU／ml上升到7269.31mIU／ml，增长55．74倍。HepAB—I组，Anti—HAV阳性率由免疫前的88．8％上升到98．9％，GMC由免疫前的98．03mIU／ml上升到5174．76mlU／ml，增长58．35倍。HepAB—I组Anti—HBs阳性[≥10mIU／m1]率由免疫前的72．9％上升到97．8％；GMC由免疫前的22．20mlU／ml上升到1226．14mIU／ml，增长54．49倍。此次试验共观察到12例不良反应，均为发热，发生率为5．7％；未发现其他不良反应。结论在健康幼儿再免疫1剂HepA—I、HepAB—I后，血清学效果和安全性良好。

Safety and Serological Effect of Revaccination of Inactivated Hepatitis A Vaccine and Combined Inactivated Hepatitis A and B Vaccine in Healthy Children

Objective To evaluate the secondary immunization serological effects and safety of inactivated hepatitis A vaccine （HepA-I） and combined inactivated hepatitis A and B vaccine （HepAB-I）. Methods An open, controlled clinical trial was conducted in 210 healthy children aged 24-38 months old who completed full immunization schedule of hepatitis B vaccine and had been vaccinated with hepatitis A attenuated live vaccine （HepA-L） over 6 months old. All the children were randomly divided into 2 groups; one group vaccinated with one dose HepA-I, the other vaccinated with one dose combined HepAB-I. Antibodies to hepatitis A virus （Anti-HAV）titers and antibody to Hepatitis B Virus Surface Antigen （Anti-HBs） titers were tested before and one month after vaccination. Potential adverse reactions were observed within 72 hours after vaccination. Results HepA-I group Anti-HAV Positive （ ≥ 20mlU/ ml）rate increase from 95.1% to 100.0% and the geometric mean concentration （GMC） increase from 124.41mIU/ml to7269.3 lmIU/ml （ increased by 55.74times）. HepAB-I group Anti-HAV rate increase from 88.8% to 98.9% and the Anti-HAV GMC increase from 98.03mIU/ml to 5174.76mIU/ml （increased by 58.35 times）. The Anti-HBs positive （≥ 10mIU/ml） rate increase from 72.9% to 97.8% and the Anti-HBs GMC increase from 22.20mIU/ml to 1226.14mlU/ml （increased by 54.49 times） 12 cases with adverse reactions were observed and all of them were fever. The incidence was 5.7% and no other adverse reactions. Conclusion Secondary immunization of （HepA-I） and （HepAB-I） showed effective serological effects and good safety in children.