Tejedor Torres J C, Reyes Pecharromán S, Pérez Rivilla A, Sayalero Martín M, Aybar Garciá L, Sánchez de León L, Puyol Buil P
Servicio de Pediatría, Hospital de Móstoles, Madrid.
An Esp Pediatr. 1993 Sep;39(3):243-7.
A prospective evaluation of the immunogenicity, protective efficacy and safety of the recombinant hepatitis B vaccine associated to the immunoglobulin (IG) in newborns with high risk of infection by the hepatitis B virus was carried out. Two groups of newborns were used. The first group was formed by children with HBsAG carrier mothers (56 children) and the second group consisted of newborns of mothers negative for HBsAG, but having a high risk of infection (21 children). Within the first few hours of life, all of the newborns received a dose (20 mcg) or recombinant vaccine and 0.5 ml of IG. New doses of vaccine were administered at one and six months of life. At eight months of age, the anti-HBs seroconversion rate in children belonging to groups 1 and 2 was 100%, with an elevated anti-HBs titer and with no detected cases of positive HBsAG. On a long term basis (39 +/- 5 months), only 5.6% of the children present an anti-HBs titer < 10 mUI/ml. The recombinant hepatitis B vaccine associated to IG is immunogenic and provides efficient protection in newborns. Important side effects were not observed.
对乙型肝炎病毒感染高危新生儿中与免疫球蛋白（IG）联合使用的重组乙型肝炎疫苗的免疫原性、保护效力和安全性进行了前瞻性评估。使用了两组新生儿。第一组由母亲为HBsAG携带者的儿童组成（56名儿童），第二组由HBsAG阴性但感染风险高的母亲所生的新生儿组成（21名儿童）。在出生后的头几个小时内，所有新生儿均接种一剂（20微克）重组疫苗和0.5毫升IG。在1个月和6个月龄时接种新的疫苗剂量。在8个月龄时，第1组和第2组儿童的抗-HBs血清转化率为100%，抗-HBs滴度升高，未检测到HBsAG阳性病例。长期来看（39±5个月），仅5.6%的儿童抗-HBs滴度<10 mUI/ml。与IG联合使用的重组乙型肝炎疫苗具有免疫原性，可为新生儿提供有效的保护。未观察到重要的副作用。
