Characterization and immunogenicity of meningococcal group C conjugate vaccine prepared using hydrazide-activated tetanus toxoid

Vaccine. 2007 Oct 10;25(41):7261-70. doi: 10.1016/j.vaccine.2007.07.037. Epub 2007 Aug 7.

Abstract

The steps to produce, purify and control an immunogenic Brazilian conjugate vaccine against group C meningococcus (MenCPS-TT) using hydrazide-activated tetanus toxoid were developed. The conjugation methodology reduced the reaction time easily allowing scale-up. One freeze-dried pilot vaccine lot purified by tangential filtration, showed satisfactory quality control results including safety and stability. The pilot vaccine was immunogenic in mice in a dose-dependent fashion generating a 10-20-fold rise in IgG response in mice. The vaccine also induced high bactericidal titers. Vaccine concentrations of 1 and 0.1 microg showed higher avidity indices, suggesting induction of immunologic memory. These results support initiation of Phase I clinical studies with the MenCPS-TT conjugate vaccine.

MeSH terms

  • Animals
  • Antibodies, Bacterial / blood
  • Antibody Affinity
  • Dose-Response Relationship, Immunologic
  • Drug Stability
  • Filtration / methods
  • Immunoglobulin G / blood
  • Meningococcal Vaccines / chemistry
  • Meningococcal Vaccines / immunology*
  • Meningococcal Vaccines / isolation & purification
  • Meningococcal Vaccines / toxicity
  • Mice
  • Microbial Viability
  • Tetanus Toxoid / chemistry
  • Tetanus Toxoid / immunology*
  • Tetanus Toxoid / metabolism

Substances

  • Antibodies, Bacterial
  • Immunoglobulin G
  • Meningococcal Vaccines
  • Tetanus Toxoid
  • serogroup C meningococcal conjugate vaccine