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Published on: December 19, 2020
Characterization and immunogenicity of meningococcal group C conjugate vaccine prepared using hydrazide-activated
I A F B Silveira1, R C Bastos, M S Neto
1Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil. ivna@bio.fiocruz.br
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.
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