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.

• Authors: R 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
• Journal: Developments in biological standardization (Dev Biol Stand) Vol. 54 Pg. 287-92 ( 1983) ISSN: 0301-5149 [Print] Switzerland
• PMID: 6228469 (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)