Randomized, comparative trial of 20 micrograms vs 40 micrograms Engerix B vaccine in hepatitis B vaccine non-responders

Vaccine. 1997 Mar;15(4):353-6. doi: 10.1016/s0264-410x(96)00202-2.

Abstract

Fifty-two adults who had previously received 4 x 20 micrograms doses of hepatitis B [Engerix-B] vaccine (appropriately administered into the deltoid muscle) and who had failed to develop detectable anti-HBs were randomized to receive a fifth dose of Engerix-B (either 20 micrograms or 40 micrograms) intramuscularly (deltoid). The participants were blinded as to the contents of the syringe. Anti-HBs was tested (by EIA) 3 months after the injection. Anti-HBs results from 45 non-responders were evaluable. Seven vaccinees were excluded; four of these on the basis of failure to have follow-up blood collected and three who were found to be anti-HBc positive (one HBsAg positive). Twelve of 22 (54.5%) of those receiving 20 micrograms of HB vaccine developed anti-HBs, whereas 10 of 23 (43.5%) who received 40 micrograms developed anti-HBs, showing no significant difference between the regimens. The mean geometric titres were 93 +/- 50 and 86 +/- 51 IU l-1, respectively. Vaccinee groups were well matched for age, sex and body mass index and the interval between injection and bleeding. Side-effects in those receiving the double (40 micrograms) dose were no different from those receiving the normal (20 micrograms) adult dose. On the basis of this study, a fifth dose of vaccine in non-responsive vaccinees is recommended. No significant advantage of 40 micrograms over 20 micrograms of vaccine was observed. Whilst smoking and obesity were common in this cohort of non-responders and probably contributed to the individuals primary non-responsive state, these factors had no unfavourable effect on response to a fifth dose of vaccine.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Body Mass Index
  • Case-Control Studies
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / biosynthesis
  • Hepatitis B Vaccines / administration & dosage*
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Immunization, Secondary
  • Injections, Intramuscular
  • Male
  • Middle Aged
  • Treatment Failure
  • Vaccines, Synthetic / administration & dosage*
  • Vaccines, Synthetic / immunology*

Substances

  • Engerix-B
  • Hepatitis B Antibodies
  • Hepatitis B Vaccines
  • Vaccines, Synthetic