上海市黄浦区新生儿血源乙型肝炎疫苗免疫后23年免疫效果追踪研究

Evaluation on the immunization efficacy on the 23 years who had received plasma-derived HBV vaccine as newborns

目的观察血源乙型肝炎（乙肝）疫苗免疫的长期效果。方法对上海市黄浦区1986年出生并接种乙肝疫苗的新生儿进行隔年随访，采血检测乙肝表面抗原（HBsAg）、乙肝表面抗体（抗-HBs）、乙肝核心抗体（抗-HBc），与本底对照（1984—1985年HBV横断面调查结果）以及外对照（1991年开展的相邻区域同年出生但未接种乙肝疫苗儿童调查的结果）相比计算保护效果。结果随访队列23年问共计采集血液标本5993份，抗-HBs阳性率随免疫时间延长逐渐下降（从89．01％下降至18．77％），平均为40．39％；抗-HBc各年阳性率平均值在1．87％上下波动；HBsAg阳性率波动保持在1．00％（0．46％～0．98％）以下，平均为0．62％（37／5993），与本底对照相比，各年龄组疫苗的保护效果在81．37％-95．78％；与外对照相比，疫苗保护效果为72．76％。结论血源乙肝疫苗中长期保护效果良好，免疫后23年无加强免疫的必要。

Objective To observe the long-term effect of plasma-derived HBV vaccine. Methods The effect of a plasma-derived HBV vaccine which was given to children born in 1986 in Huangpu district in Shanghai were followed up once every two years and testing for HBsAg, anti-HBs and anti-HBc was carried out. Compared to background results from cross-sectional survey of hepatitis B virus in 1984 and 1985 （as internal control） as well as finding of survey targeted in non-plasma- derived HBV vaccine of children born in the same time in the nearby area from results investigated in 1991 （as external control）, positive rate was calculated to assess the effect of protection. Results The population immunized was followed up for 23 years and 5993 blood samples were collected. During the period of follow-up, the positive rate of anti-HBs decreased from 89.01% to 18.77% and the average level was 40.39%. The average positive rate of anti-HBc was 1.87%. The annual positive rate fluctuated around the average level. HBsAg positive rate remained less than 1.00% （0.46%-0.98%）, with an average of 0.62% （37/5993）. Ranges of positive efficacy were from 81.37% to 95.78% against background control and 72.76% against external control. Conclusion The plasma-derived HBV vaccine showed a good long-term protective effect and there was no need for boosting the immunization 23 years later.