Rapid seroprotection against hepatitis B following the first dose of a Pre-S1/Pre-S2/S vaccine

J Hepatol. 2001 Jan;34(1):123-7. doi: 10.1016/s0168-8278(00)00082-9.

Abstract

Background/aims: Will immunization with an experimental Pre-S1/Pre-S2/S hepatitis B vaccine (Bio-Hep-B) induce faster seroprotection using fewer doses as compared with a yeast derived S vaccine (Engerix B).

Methods: Healthy volunteers, n = 36, mean age 23 y, randomized to receive 2 or 3 doses of both vaccines given months 0 and 6, or 0, 1 and 6.

Results: Following primary immunization, seroprotection occurred in 6, 39, 53 and 60% in the Bio-Hep-B group at weeks 1, 2, 3 and 4, compared with 0, 12, 18 and 12.5% in the Engerix-B vaccinees, respectively. Six months following injection of the first dose, seroprotection was 70 and 25% in Pre-S/S and S vaccinees respectively. Area under the curve in vaccinees of Bio-Hep-B; versus Engerix-B showed mean anti-HBs level of 365 +/- 166 and 85 +/- 48 mIU/ml x day respectively (P = 0.012). At month 7, 100% seroprotection was achieved in both groups while anti-HBs rose from 81 to 28,800 mIU/ml and from 12 to 923 mIU/ml in recipients of Bio-Hep-B and Engerix-B respectively (P < 0.025).

Conclusions: Bio-Hep-B induces rapid seroprotection against hepatitis B in 60-70% of vaccinees, within 4-24 weeks after the first dose. Two instead of the conventional three doses of the Pre-S/S vaccine may be sufficient to induce adequate seroprotection.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Female
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / blood*
  • Hepatitis B Surface Antigens / immunology*
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Immunization
  • Male
  • Protein Precursors / immunology*
  • Time Factors
  • Vaccines, Synthetic / immunology*

Substances

  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Protein Precursors
  • Vaccines, Synthetic
  • presurface protein 1, hepatitis B surface antigen
  • presurface protein 2, hepatitis B surface antigen