论文部分内容阅读
目的评价10μg/剂重组乙型肝炎(乙肝)疫苗(酿酒酵母)接种2~15岁儿童和青少年人群的免疫原性。方法在江苏丹阳招募1 288名2~15岁健康儿童和青少年随机入选为试验组(649人)及对照组(639人),按0,1,2月程序分别接种10μg和5μg剂型康泰公司生产的酵母乙肝疫苗。于第1针接种前及接种后1、2和3月时采集静脉血并分离血清,检测乙肝表面抗体(抗-HBs)指标,计算几何平均浓度(GMC)。结果全程免疫后1月时试验组人群抗-HBs水平显著高于对照组(1 375.0mIU/ml vs 854.69mIU/ml,P<0.05);而试验组与对照组抗-HBs阳转率均呈现较高水平(99.68%vs 99.00%,P>0.05)。结论 10μg剂型酿酒酵母乙肝疫苗免疫儿童和青少年人群的抗体水平显著优于5μg剂型疫苗,适用于2~15岁青少年儿童的预防接种。
Objective To evaluate the immunogenicity of 10 μg / dose recombinant hepatitis B vaccine (Saccharomyces cerevisiae) in children and adolescents aged 2-15 years. Methods A total of 1 288 healthy children and adolescents aged 2-15 years were enrolled in Danyang, Jiangsu Province. Randomly selected as experimental group (649 persons) and control group (639 persons), 10 and 5 μg doses of Kangtai Yeast hepatitis B vaccine. Venous blood was collected before 1 st needle inoculation and at 1, 2 and 3 months after inoculation. Serum samples were collected for determination of anti-HBs antibody and geometric mean concentration (GMC). Results The level of anti-HBs in the test group was significantly higher than that in the control group (1 375.0 mIU / ml vs 854.69 mIU / ml, P <0.05) at 1 month after the whole immunization. However, the positive rate of anti-HBs in the test group and the control group Higher level (99.68% vs 99.00%, P> 0.05). Conclusion The antibody level of 10μg dosage form of Saccharomyces cerevisiae HB vaccine immunized children and adolescents is significantly better than that of 5μg dosage form vaccines, which is suitable for vaccination of adolescent children aged 2-15 years.