Phase I clinical evaluation of a synthetic oligosaccharide-protein conjugate vaccine against Haemophilus influenzae type b in human adult volunteers

Clin Vaccine Immunol. 2006 Sep;13(9):1052-6. doi: 10.1128/CVI.00144-06.

Abstract

Since 1989, we have been involved in the development of a vaccine against Haemophilus influenzae type b. The new vaccine is based on the conjugation of synthetic oligosaccharides to tetanus toxoid. Our main goals have been (i) to verify the feasibility of using the synthetic antigen and (ii) to search for new production alternatives for this important infant vaccine. Overall, eight trials have already been conducted with adults, children (4 to 5 years old), and infants. We have described herein the details from the first two phase I clinical trials conducted with human adult volunteers under double blind, randomized conditions. The participants each received a single intramuscular injection to evaluate safety and initial immunogenicity. We have found an excellent safety profile and an antibody response similar to the one observed for the control vaccine.

Publication types

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

MeSH terms

  • Adult
  • Antibodies, Bacterial / blood
  • Antibody Specificity
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Haemophilus Infections / immunology
  • Haemophilus Infections / prevention & control*
  • Haemophilus Vaccines / administration & dosage*
  • Haemophilus Vaccines / adverse effects
  • Haemophilus Vaccines / immunology
  • Haemophilus influenzae type b / immunology*
  • Humans
  • Immunoglobulin A / immunology
  • Immunoglobulin G / immunology
  • Immunoglobulin M / immunology
  • Male
  • Retrospective Studies
  • Serum Bactericidal Test
  • Vaccines, Conjugate

Substances

  • Antibodies, Bacterial
  • Haemophilus Vaccines
  • Immunoglobulin A
  • Immunoglobulin G
  • Immunoglobulin M
  • Vaccines, Conjugate