Overview of clinical studies with hepatitis B vaccine made by recombinant DNA

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      The Merck, Sharp and Dohme hepatitis B vaccine formulated from HBsAg produced by a recombinant strain of Saccharomyces cerevisiae has proven to be highly immunogenic and safe. A 10 μg dose of the vaccine produced an anti-HBs response of ⩾ 10 IU/l in 91 % or more of healthy adults who completed the three-dose regimen. Children responded well to all levels of vaccine antigen utilised but developed maximum anti-HBs titres with 5 μg doses. The age of the vaccine recipient affected responsiveness. Younger adults (20–29 years) responded more rapidly and with higher anti-HBs titres than did older adults (⩾ 50 years). Children responded faster and with higher anti-HBs levels than younger adults. Clinical reactions reported after vaccination were mild and transient.
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