Effects of antigen dose and immunization regimens on antibody responses to a cytomegalovirus glycoprotein B subunit vaccine

J Infect Dis. 1999 Nov;180(5):1700-3. doi: 10.1086/315060.

Abstract

The purpose of this phase I study was to evaluate the safety and immunogenicity of 2 doses of cytomegalovirus glycoprotein B (CMV gB)/MF59 vaccine at 3 different immunization schedules. Ninety-five volunteers were randomized to 6 groups. Antibodies to gB represent the majority of the CMV-specific neutralizing response. Three groups received 5 microgram of gB antigen combined with MF59 (a proprietary adjuvant) and 3 groups received a 30-microgram dose at 0, 1, and 2 months; 0, 1, and 4 months; or 0, 1, and 6 months. The vaccine was well tolerated, and there was no significant difference in antibody production between the 2 doses. The vaccine induced highest antibody titers when given at 0, 1, and 6 months. A low dose of CMV gB/MF59 may be the preferred dose for future studies.

Publication types

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

MeSH terms

  • Adjuvants, Immunologic
  • Adult
  • Antibodies, Viral / blood*
  • Antigens, Viral / administration & dosage
  • Antigens, Viral / immunology
  • Cytomegalovirus / immunology*
  • Cytomegalovirus Infections / prevention & control
  • Female
  • Humans
  • Immunization Schedule
  • Male
  • Middle Aged
  • Viral Envelope Proteins / administration & dosage*
  • Viral Envelope Proteins / immunology*
  • Viral Plaque Assay
  • Viral Vaccines / administration & dosage*
  • Viral Vaccines / immunology

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Antigens, Viral
  • Viral Envelope Proteins
  • Viral Vaccines
  • glycoprotein B, Simplexvirus