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Recombinant DNA hepatitis B vaccine containing Pre-S components of the HBV coat protein--a preliminary study on immunogenicity.

Abstract：

: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.

journal_name

Vaccine

journal_title

Vaccine

authors

Yap I,Guan R,Chan SH

doi

10.1016/0264-410x(92)90391-v

subject

Has Abstract

pub_date

1992-01-01 00:00:00

pages

439-42

issue

7

eissn

0264-410X

issn

1873-2518

pii

0264-410X(92)90391-V

journal_volume

10

pub_type

临床试验,杂志文章,随机对照试验

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