Whittle H C, Inskip H, Hall A J, Mendy M, Downes R, Hoare S
Medical Research Council Laboratories, Fajara, Banjul, The Gambia.
Lancet. 1991 Mar 30;337(8744):747-50. doi: 10.1016/0140-6736(91)91367-4.
358 children in the Gambian villages of Keneba and Manduar, where hepatitis B virus (HBV) infection is endemic, were vaccinated with plasma-derived vaccine against HBV according to one of four regimens and followed for up to 4 years. Two regimens by which vaccine was injected intradermally into children between 0 and 4 years old led to peak geometric mean (95% CI) concentrations of antibody against HBV surface antigen of 270 (202-358) and 555 (418-748) mlU/ml. The third regimen--intramuscular vaccination of children aged between 0 and 4 years--gave geometric mean peak antibody concentrations of 926 (765-1122) mlU/ml. A fourth regimen was intramuscular vaccination of children between 1 and 9 months old, which gave geometric mean antibody concentrations of 5431 (3903-75,456) mlU/ml. Despite these widely divergent responses and a 89% decay in antibody over the first 2 years, vaccination against HBV was 97% effective in preventing chronic infection. Vaccination was less effective in preventing uncomplicated infection: 5.3% of 264 vaccinees in Keneba and 19.1% of 94 vaccinees in Manduar tested positive for antibody to HBV core antigen. These "breakthrough infections" did not differ in frequency between regimens, and were associated with low initial antibody responses and chronic maternal carriage of HBV.
在乙型肝炎病毒（HBV）感染呈地方性流行的冈比亚凯内巴和曼杜阿尔村庄，358名儿童按照四种方案之一接种了血浆源性乙肝疫苗，并随访了长达4年。两种方案是对0至4岁儿童进行皮内注射疫苗，其抗HBV表面抗原抗体的几何平均（95%CI）峰值浓度分别为270（202 - 358）和555（418 - 748）mIU/ml。第三种方案是对0至4岁儿童进行肌肉注射疫苗，其抗体几何平均峰值浓度为926（765 - 1122）mIU/ml。第四种方案是对1至9个月大的儿童进行肌肉注射疫苗，其抗体几何平均浓度为5431（3903 - 75456）mIU/ml。尽管有这些差异很大的反应，且抗体在最初2年内下降了89%，但乙肝疫苗预防慢性感染的有效率为97%。疫苗在预防非复杂性感染方面效果较差：凯内巴264名接种疫苗者中有5.3%、曼杜阿尔94名接种疫苗者中有19.1%的HBV核心抗原抗体检测呈阳性。这些“突破性感染”在各方案之间的发生率没有差异，且与初始抗体反应低以及母亲慢性携带HBV有关。
