Lai C L, Yeoh E K, Chang W K, Lo V W, Ng L N
J Infect. 1986 Jul;13 Suppl A:19-25. doi: 10.1016/s0163-4453(86)92623-x.
In a prospective randomised trial, children of hepatitis B carriers who were 3 months to 11 years of age and negative for all hepatitis B viral markers were randomised to receive (a) two doses of 5 micrograms of hepatitis B recombinant DNA yeast vaccine (H-B-VAX II) at 0 and 1 month (Group I), (b) three doses of 5 micrograms of H-B-VAX II at 0, 1 and 6 months (Group II) and (c) three doses of 10 micrograms of plasma-derived hepatitis B vaccine (H-B-VAX) (Group III). In the 141 children receiving H-B-VAX II, i.e. in Group I and Group II, side-effects were few and transient. Fever occurred in 10% of the vaccinees. Anti-HBs response rate was 96-100% by 8 months. None of the vaccinees became positive for anti-HBc. The geometric mean of the anti-HBs titre at 8 months was higher for Group II than for Group I (P less than 0.001). The practical and theoretical necessity for this higher titre of anti-HBs in the prevention of future infection by the hepatitis B virus is discussed. Both the two-dose regime and the three-dose regime of 5 micrograms of H-B-VAX II were safe, effective and immunogenic in children.
在一项前瞻性随机试验中，对年龄在3个月至11岁、所有乙肝病毒标志物均为阴性的乙肝携带者儿童进行随机分组，分别接受以下疫苗接种：(a) 在0月和1月各接种两剂5微克重组酵母乙肝疫苗（H-B-VAX II）（第一组）；(b) 在0月、1月和6月各接种三剂5微克H-B-VAX II（第二组）；(c) 接种三剂10微克血浆源性乙肝疫苗（H-B-VAX）（第三组）。在141名接种H-B-VAX II的儿童中，即第一组和第二组，副作用较少且为一过性。10%的接种者出现发热。到8个月时，抗-HBs应答率为96%-100%。所有接种者抗-HBc均未转为阳性。第二组8个月时抗-HBs滴度的几何平均值高于第一组（P<0.001）。讨论了这种较高抗-HBs滴度在预防未来乙肝病毒感染方面的实际和理论必要性。5微克H-B-VAX II的两剂接种方案和三剂接种方案在儿童中均安全、有效且具有免疫原性。
