Randomised placebo-controlled trial of hepatitis B surface antigen vaccine in french haemodialysis units: II, Haemodialysis patients

Lancet. 1981 Apr 11;1(8224):797-800. doi: 10.1016/s0140-6736(81)92679-9.

Abstract

A vaccine against hepatitis B surface antigen (Institut Pasteur Production) was assessed in 138 haemodialysis patients in a placebo-controlled randomised double-blind trial. In an interim analysis, hepatitis B infections were observed in 21% of the vaccine group and 45% of the placebo group (p less than 0.02). 2 of the infections in the vaccine group and 12 of the infections in the placebo group occurred after the third injection. 60% of the vaccine recipients had an immune response. 4 months after the first injection the mean titre of anti-HBs was 120 mlU/ml.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Clinical Trials as Topic
  • Double-Blind Method
  • Female
  • France
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / analysis
  • Hepatitis B Surface Antigens / immunology*
  • Humans
  • Male
  • Middle Aged
  • Random Allocation
  • Renal Dialysis* / adverse effects
  • Risk
  • Viral Vaccines / therapeutic use*

Substances

  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Viral Vaccines