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Hepatitis B vaccine: safety study in anti-HBs seronegative human volunteers

Kaufmann, R.; Mondorf, A.W.; Uthemann, H.; Bauer, H.; Prince, A.M.

Developments in Biological Standardization 54: 229-235

1983

ISSN/ISBN: 0301-5149
PMID: 6228463
Document Number: 198579
A hepatitis B vaccine which has been prepared from HBsAg and HBeAg positive human plasma and which consists of purified HBsAg in an alum suspension was investigated for safety and immunogenicity in a clinical trial. Twenty-three anti-HBs seronegative volunteers received three injections each of 40 micrograms HBsAg intramuscularly. No rise in serum transaminase activities occurred during the follow-up period, and none of the volunteers developed clinical signs related to viral hepatitis. Only minor side reactions like burning or reddening at the site of injection were reported by the volunteers. 100% seroconversion occurred within 150 days after first vaccination. The subsequent two vaccinations caused a strong booster effect.

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