Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults

J Infect Dis. 2002 Dec 15;186(12):1848-51. doi: 10.1086/345763. Epub 2002 Nov 14.

Abstract

Healthy adults, 18-55 years old, were immunized once with a tetravalent (serogroups A, C, Y, and W-135) meningococcal vaccine conjugated to diphtheria toxoid at 1 of 3 doses and were monitored for safety, reactogenicity, and immunogenicity. No immediate reactions were observed. Only 1 of 89 subjects reported fever; only 1 reported any severe reactogenicity (local pain/soreness, chills, arthralgia, anorexia, and malaise). For each serogroup and in each dose group, the geometric mean serum bactericidal antibody (SBA) titer and immunoglobulin G concentration increased after immunization. In the 4- and 10-microg-dose groups, all subjects had SBA titers >/=8 against serogroups A and C, and 89% and 93% of subjects had SBA titers >/=8 against serogroups Y and W-135, respectively. The A, C, Y, and W-135 Neisseria meningitidis-diphtheria toxoid conjugate vaccine, when given to healthy adults as a single intramuscular injection of 1, 4, or 10 microg/serogroup, is acceptably tolerated and immunogenic and deserves further development.

Publication types

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

MeSH terms

  • Adult
  • Antibodies, Bacterial / biosynthesis
  • Diphtheria / immunology
  • Diphtheria / prevention & control*
  • Diphtheria Toxoid / administration & dosage*
  • Dose-Response Relationship, Immunologic
  • Female
  • Humans
  • Immunoglobulin G / blood
  • Injections, Intramuscular
  • Male
  • Meningococcal Infections / prevention & control*
  • Meningococcal Vaccines / administration & dosage*
  • Meningococcal Vaccines / immunology
  • Middle Aged
  • Vaccination*
  • Vaccines, Conjugate / administration & dosage

Substances

  • Antibodies, Bacterial
  • Diphtheria Toxoid
  • Immunoglobulin G
  • Meningococcal Vaccines
  • Vaccines, Conjugate