摘要
目的评价国产甲型和乙型肝炎（甲、乙肝）联合疫苗用于儿童加强免疫的安全性和免疫效果。方法采用开放式试验设计。选择盐城市市区具有明确甲、乙肝疫苗接种史、3～8岁的儿童，按照研究方案制定的入选标准和排除标准要求确定研究对象，采用儿童型的甲、乙肝联合疫苗加强免疫1针，接种后进行30min即时反应及3d的安全性评价，免疫后30d采集血清进行免疫效果评价，并进行统计学分析。结果符合入选标准的143名儿童接种1针甲、乙肝联合疫苗后无局部不良反应发生，仅有5人接种后30min内出现一过性轻度发热（体温〈37．512），发生率3．5％，表明疫苗安全性良好。符合入选、排除标准的113名儿童加强免疫1针后，甲肝病毒抗体（抗-HAV）总阳性率为97．3％；乙肝病毒表面抗体（抗一HBs）阳性率为100％，保护性抗体阳性率为97．3％；抗-HAV和抗-HBs几何平均浓度（GMC）分别为1618．6毫国际单位／毫升（mIU／m1）、368．7mIU／ml，GMC分别增长111．6倍和107．8倍。免疫前不同滴度抗-HAV和抗-HBs的儿童加强免疫后比较，免疫前抗体滴度低，免疫后增加幅度大。结论3～8岁儿童接种1针国产甲、乙肝联合疫苗是安全的，两种抗体水平均显著提高，且具有一定的协同作用，免疫效果良好。
Objective To evaluate the safety and immunogenicity following booster vaccination of combined hepatitis A and B vaccine in children. Methods An open designed clinical trial was performed in Yancheng City of Jiangsu Province of China. Children aged from 3-8 years were enrolled in the study. Subjects had deftnitely vaccination history of the live attenuated hepatitis A vaccine and hepatitis B vaccine.According to the inclusion criteria and exclusion crifteria of the trial protocol,subjects were administered one dose junior combined hepatitis A and B vaccine. Safety was assessed in 30 minutes and being three days observation. Immunogenicity was assessed in 30 days after vaccination and statistical analysis was carried out. Results According to the inclusion criteria, 143 children were safe. All of them have not any local reaction, only five children occurred temporary mild fever after 30 minutes. Mild fever was 3.5 96 and body temperatures were not exceed 37.5℃. The vaccine was safe. According to the inclusion criteria and exclusion criteria, 113 children were assessed in immunogenicity after booster vaccination, the anti-HAV seroconversion rate was 97.3 96, the anti-HBs seroconversion rate was 10096, the anti-HBs seroprotection rate was 97.3%. GMTs were 1618.6mIU/mL and 368.7mIU/mL respectively. Increased folds of GMTS were 111.6 and 107.8 respectively. We compared with anti-HAV and anfi-HBs antibody titer after vaccination according to the different pre-vaceination anti-HAV and anti-HBs antibody fiter of children,lower titer before vaccination was higher increased after vaccination. Conclusion The results indicated that booster inoculation with one dose domestic combined hepatitis A and B vaccine was safe during children aged 3-8 years, two antibodies has remarkable increased and is accelerative each other, the immunogenicity was well.
出处
《中国计划免疫》
2007年第1期54-59,共6页
Chinese Journal of Vaccines and Immunization
