Yap I, Guan R, Chan S H
Department of Medicine, National University of Singapore.
Vaccine. 1992;10(7):439-42. doi: 10.1016/0264-410x(92)90391-v.
A novel recombinant hepatitis B vaccine, trademarked Sci-B-Vac, was evaluated for safety, tolerability and immunogenicity in an open label trial performed in Singapore. The experimental vaccine, derived from Chinese hamster ovary (CHO) cells, consists of hepatitis B surface antigen (HBsAg) particles harbouring all three viral envelope polypeptides, the major S protein and the minor Pre-S2 and Pre-S1, in their glycosylated and non-glycosylated forms. The vaccine was administered intramuscularly at 0, 1 and 6 months. No unexpected adverse effects were observed. A high level anti-HBs response to Sci-B-Vac was indicative of its immunogenicity. Subsequent to the third injection, 100% and 92% of the 10 micrograms and 5 micrograms dose recipients, respectively, were seroprotected (anti-HBs titres greater than or equal to 10 mIU ml-1). Moreover, the geometric mean titres (GMT) of the anti-HBs response were very high: 2687 and 1473 mIU ml-1, respectively. An immunogenic advantage of Sci-B-Vac was also suggested by the rapid onset of antibody response: 96% of the 10 micrograms dose recipients were seroprotected with a GMT of 159 mIU ml-1, prior to the third injection.
一种名为Sci-B-Vac的新型重组乙型肝炎疫苗，在新加坡进行的一项开放标签试验中对其安全性、耐受性和免疫原性进行了评估。这种实验性疫苗源自中国仓鼠卵巢（CHO）细胞，由携带所有三种病毒包膜多肽（主要S蛋白以及次要的前S2和前S1）的乙型肝炎表面抗原（HBsAg）颗粒组成，这些多肽有糖基化和非糖基化两种形式。该疫苗在0、1和6个月时进行肌肉注射。未观察到意外的不良反应。对Sci-B-Vac的高水平抗-HBs反应表明了其免疫原性。第三次注射后，接受10微克和5微克剂量的受试者中，分别有100%和92%获得了血清保护（抗-HBs滴度大于或等于10 mIU/ml）。此外，抗-HBs反应的几何平均滴度（GMT）非常高：分别为2687和1473 mIU/ml。抗体反应的快速出现也表明了Sci-B-Vac的免疫原性优势：在第三次注射前，接受10微克剂量的受试者中有96%获得了血清保护，GMT为159 mIU/ml。
