Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial

Coutinho, R.A.; Lelie, N.; Albrecht-Van Lent, P.; Reerink-Brongers, E.E.; Stoutjesdijk, L.; Dees, P.; Nivard, J.; Huisman, J.; Reesink, H.W.

British Medical Journal 286(6374): 1305-1308


ISSN/ISBN: 0267-0623
PMID: 6404440
DOI: 10.1136/bmj.286.6374.1305
Accession: 042971291

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The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised placebo controlled double blind trial. At the trial end point (21.5 months), 17 hepatitis B virus infections had occurred in vaccinated subjects (attack rate 4.8%) and 56 in subjects receiving a placebo (attack rate 23.8%). This reduction in the incidence of hepatitis B virus infections in vaccinated subjects was highly significant (p less than 0.0001). Two months after the first injection 72.3% of the vaccinated subjects had formed antibodies against hepatitis B surface antigen, and this percentage increased to 89% at four months. Maximum anti-HBs titres were reached five months after the first vaccination, the geometric mean titre being 107.6 mIU. Even vaccinated subjects with a low antibody response (greater than or equal to 1 and less than 10 mIU) were found to be protected from HBsAg-positive infections. The vaccine had no serious side effects.