Overview of clinical studies with hepatitis B vaccine made by recombinant DNA

J Infect. 1986 Jul:13 Suppl A:39-45. doi: 10.1016/s0163-4453(86)92668-x.

Abstract

The Merck, Sharp and Dohme hepatitis B vaccine formulated from HBsAg produced by a recombinant strain of Saccharomyces cerevisiae has proven to be highly immunogenic and safe. A 10 micrograms dose of the vaccine produced an anti-HBs response of greater than or equal to 10 IU/l in 91% or more of healthy adults who completed the three-dose regimen. Children responded well to all levels of vaccine antigen utilised but developed maximum anti-HBs titres with 5 micrograms doses. The age of the vaccine recipient affected responsiveness. Younger adults (20-29 years) responded more rapidly and with higher anti-HBs titres than did older adults (greater than or equal to 50 years). Children responded faster and with higher anti-HBs levels than younger adults. Clinical reactions reported after vaccination were mild and transient.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Age Factors
  • Child
  • Child, Preschool
  • Clinical Trials as Topic
  • DNA, Recombinant
  • Hepatitis B Antibodies / biosynthesis*
  • Hepatitis B Surface Antigens / genetics
  • Hepatitis B Vaccines
  • Humans
  • Immunoglobulin G / analysis
  • Infant
  • Middle Aged
  • Recombinant Proteins
  • Saccharomyces cerevisiae / genetics
  • Viral Hepatitis Vaccines / adverse effects
  • Viral Hepatitis Vaccines / immunology*

Substances

  • DNA, Recombinant
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Immunoglobulin G
  • Recombinant Proteins
  • Viral Hepatitis Vaccines