Lee P I, Lee C Y, Huang L M, Chang M H
Department of Pediatrics, National Taiwan University Hospital, Taipei, Republic of China.
J Pediatr. 1995 May;126(5 Pt 1):716-21. doi: 10.1016/s0022-3476(95)70398-5.
To evaluate the long-term protection afforded by the vaccine, recombinant hepatitis B (HB) vaccine was given to 171 infants born to hepatitis B e antigen-positive carrier mothers. Group A (53 infants) and group B (57 infants) received four doses of HB vaccine at birth and at 1, 2, and 12 months of age, with a dose of 20 micrograms in group A and 10 micrograms in group B. Group C (61 infants) received three 20 micrograms doses of HB vaccine at birth and at 1 and 6 months of age. These children were followed up annually up to 5 years of age. Six children (4%) became HB carriers before 1 year of age, and the carrier state persisted to the end of follow-up. The overall seropositive rate of HB surface antibody (anti-HBs) dropped from 99% at 1 year of age to 83% at 5 years of age. Among 548 serum pairs taken at 1-year intervals from children negative for HB surface antigen (HBsAg), a fourfold rise of anti-HBs titer was noted in 58 (11%) and a 10-fold rise of anti-HBs was noted in 17 (3%). Maternal HB core antibody disappeared in most children (151/152, 99%) before 2 years of age. Natural infections, as judged by persistence or reappearance of HB core antibody, occurred in 19 of 163 (12%) HBsAg-negative children. None of these episodes was associated with HBsAg positivity. We conclude that the long-term protection afforded by recombinant HB vaccine is satisfactory and that a further booster dose before 5 years of age is not necessary.
为评估疫苗提供的长期保护作用，对171名母亲为乙肝e抗原阳性携带者的婴儿接种了重组乙肝疫苗。A组（53名婴儿）和B组（57名婴儿）在出生时以及1、2和12月龄时接种4剂乙肝疫苗，A组每剂20微克，B组每剂10微克。C组（61名婴儿）在出生时以及1和6月龄时接种3剂20微克的乙肝疫苗。对这些儿童进行了长达5年的年度随访。6名儿童（4%）在1岁前成为乙肝携带者，且携带者状态持续至随访结束。乙肝表面抗体（抗-HBs）的总体血清阳性率从1岁时的99%降至5岁时的83%。在从乙肝表面抗原（HBsAg）阴性儿童中每隔1年采集的548对血清中，58对（11%）抗-HBs滴度出现4倍升高，17对（3%）抗-HBs滴度出现10倍升高。大多数儿童（151/152，99%）在2岁前乙肝核心抗体消失。根据乙肝核心抗体的持续存在或再次出现判断，163名HBsAg阴性儿童中有19名（12%）发生了自然感染。这些感染事件均未伴有HBsAg阳性。我们得出结论，重组乙肝疫苗提供的长期保护作用令人满意，5岁前无需进一步加强接种。
