Grosheide P M, del Canho R, Heijtink R A, Nuijten A S, Zwijnenberg J, Bänffer J R, Wladimiroff Y W, Botman M J, Mazel J A, de Gast G C
Department of Internal Medicine, Academic Hospital, Dijkzigt, The Netherlands.
Am J Dis Child. 1993 Dec;147(12):1316-20. doi: 10.1001/archpedi.1993.02160360058019.
To assess the efficacy of late active immunization against hepatitis B concomitant with diphtheria, pertussis, tetanus, and polio vaccine in high-risk infants receiving hepatitis B immune globulin at birth.
Randomized study of infants born to mothers positive for hepatitis B surface antigen (HBsAg) and hepatitis Be antigen (HBeAg).
Three large city hospitals and one rural area providing prenatal care and obstetric services.
Eighty neonates of HBsAg- and HBeAg-positive carrier mothers received 0.5 mL/kg of body weight hepatitis B immune globulin within 2 hours of birth and hepatitis B vaccine (10 micrograms) at 0, 1, 2, and 11 months of age (group A) or at 3, 4, 5, and 11 months of age concomitant with diphtheria, pertussis, tetanus, and polio immunization (group B). A second dose of hepatitis B immune globulin was given to infants on schedule B at 3 months.
Blood samples were collected at 0, 3, 6, 11, and 12 months of age and tested for antibodies against hepatitis B core antigen and HBsAg. Follow-up visits were scheduled annually up to 5 years of age.
Eight infants were excluded from analysis. During the study period, six children became HBsAg carriers, three in each group, which corresponds to a 5-year incidence of infection of 9% and 8% for groups A (three of 35) and B (three of 37), respectively. Subclinical infections (persistent anti-HBc positivity beyond month 12 or appearance of anti-HBc) were encountered in another eight infants (four in each group).
Late active immunization starting at 3 months of age appears to provide similar protective efficacy as active immunization starting at birth when combined with hepatitis B immune globulin at 0 and 3 months of age.
评估在出生时接受乙肝免疫球蛋白的高危婴儿中，乙肝联合白喉、百日咳、破伤风和脊髓灰质炎疫苗进行后期主动免疫的效果。
对乙肝表面抗原（HBsAg）和乙肝e抗原（HBeAg）阳性母亲所生婴儿进行的随机研究。
三家大型城市医院和一个提供产前护理及产科服务的农村地区。
80名HBsAg和HBeAg阳性携带者母亲的新生儿在出生后2小时内接受了0.5 mL/kg体重的乙肝免疫球蛋白，并在0、1、2和11月龄时接种乙肝疫苗（10微克）（A组），或在3、4、5和11月龄时接种，同时接种白喉、百日咳、破伤风和脊髓灰质炎疫苗（B组）。按B方案接种的婴儿在3个月时按计划接种了第二剂乙肝免疫球蛋白。
在0、3、6、11和12月龄时采集血样，检测乙肝核心抗原和HBsAg抗体。安排每年随访直至5岁。
8名婴儿被排除在分析之外。在研究期间，6名儿童成为HBsAg携带者，每组3名，A组（35名中的3名）和B组（37名中的3名）的5年感染发生率分别为9%和8%。另外8名婴儿（每组4名）出现亚临床感染（12个月后持续抗-HBc阳性或抗-HBc出现）。
3月龄开始的后期主动免疫与0和3月龄时联合乙肝免疫球蛋白从出生开始的主动免疫似乎具有相似的保护效果。
