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

• Published in: Vaccine Vol. 25; no. 41; pp. 7261 - 7270
• Main Authors: Silveira, I.A.F.B, Bastos, R.C, Neto, M.S, Laranjeira, A.P, Assis, E.F, Fernandes, S.A.R, Leal, M.L, Silva, W.C, Lee, C.-H, Frasch, C.E, Peralta, J.M, Jessouroun, E
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 10.10.2007; Elsevier; Elsevier Limited
• Subjects: Allergy and Immunology; Animals; Antibodies, Bacterial - blood; Antibody Affinity; Antigens; Applied microbiology; Bacteriology; Biological and medical sciences; Conjugate vaccine; Dose-Response Relationship, Immunologic; Drug Stability; Filtration - methods; Fundamental and applied biological sciences. Psychology; High avidity IgG; Immunoglobulin G - blood; Meningitis; Meningococcal group C; Meningococcal Vaccines - chemistry; Meningococcal Vaccines - immunology; Meningococcal Vaccines - isolation & purification; Meningococcal Vaccines - toxicity; Methods; Mice; Microbial Viability; Microbiology; Miscellaneous; Neisseria meningitidis; Proteins; Quality control; Reductive amination; Serum bactericidal activity; Spectrum analysis; Streptococcus infections; Sucrose; Tetanus; Tetanus Toxoid - chemistry; Tetanus Toxoid - immunology; Tetanus Toxoid - metabolism; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Brazil; Reductive amination; Meningococcal group C; High avidity IgG; Conjugate vaccine; Serum bactericidal activity; Toxoid; Neisseriaceae; IgG; Neisseria meningitidis; Vaccine; Infection; Immunogenicity; Bacteriosis; Bacteria; Micrococcales; Avidity; Serum; Tetanus; Meningococcal disease
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2007.07.037

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 μg showed higher avidity indices, suggesting induction of immunologic memory. These results support initiation of Phase I clinical studies with the MenCPS–TT conjugate vaccine.