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Efficacy trial of heat-inactivated hepatitis B vaccine (CLB) in male homosexuals in the Netherlands.

Abstract
The efficacy of a heat-inactivated hepatitis B virus (HBV) vaccine, containing 3 micrograms-HBsAg, was studied among a group of 800 susceptible homosexual men. The trial was conducted randomized, placebo-controlled and double blind. At the trial end point (21.5 months) the attack-rate for all HBV infections together was 4.8% among vaccinees and 23.8% among the placebos (p less than 0.0001). Four months after the first injection 89% of the vaccinees had formed anti-HBs and this percentage declined only slightly during the follow-up period. Maximum titers were reached 5 months after the first vaccination. None of the vaccinees who responded to the vaccine with anti-HBs greater than or equal to 1 mIU/ml developed a HBsAg positive infection. The vaccine had no serious side-effects.
AuthorsR A Coutinho, P N Lelie, P Albrecht-van Lent, L Stoutjesdijk, J Huisman, H Kuipers, L J Schut, E E Reerink-Brongers, H W Reesink, W G van Aken
JournalDevelopments in biological standardization (Dev Biol Stand) Vol. 54 Pg. 287-92 ( 1983) ISSN: 0301-5149 [Print] SWITZERLAND
PMID6228469 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Hepatitis B Antibodies
  • Hepatitis B Vaccines
  • Viral Vaccines
Topics
  • Clinical Trials as Topic
  • Hepatitis B Antibodies (analysis)
  • Hepatitis B Vaccines
  • Homosexuality
  • Hot Temperature
  • Humans
  • Male
  • Netherlands
  • Viral Vaccines (immunology)

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