Safety and preliminary immunogenicity of MenC/P64k, a meningococcal serogroup C conjugate vaccine with a new recombinant carrier

FEMS Immunol Med Microbiol. 2006 Apr;46(3):386-92. doi: 10.1111/j.1574-695X.2006.00047.x.

Abstract

This study reports the preliminary assessment of the safety and immunogenicity of the first serogroup C conjugate vaccine candidate that includes meningococcal P64k recombinant protein as the carrier (MenC/P64k). Twenty volunteers were recruited for a double-blind, randomized, controlled phase I clinical trial, receiving a single dose of MenC/P64k (study group) and a single dose of the commercial polysaccharide vaccine AC (control group). Only mild reactions were observed. No statistical differences were detected between the antipolysaccharide C IgG responses of both groups as well as between bactericidal serum titre (P > 0.05). The MenC/P64k vaccine was found to have a good safety profile, to be well tolerated and immunogenic.

Publication types

  • Clinical Trial, Phase I
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antibodies, Bacterial / blood
  • Bacterial Outer Membrane Proteins / immunology*
  • Complement Fixation Tests
  • Cuba
  • Double-Blind Method
  • Enzyme-Linked Immunosorbent Assay
  • Humans
  • Male
  • Meningococcal Infections / immunology*
  • Meningococcal Infections / prevention & control
  • Meningococcal Vaccines / adverse effects*
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis, Serogroup C / immunology*
  • Vaccines, Conjugate / adverse effects
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Bacterial Outer Membrane Proteins
  • Meningococcal Vaccines
  • Vaccines, Conjugate
  • lpdA protein, Neisseria meningitidis