title: Characterization and immunogenicity of meningococcal group C conjugate vaccine prepared using hydrazide-activated tetanus toxoid.
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.
authors: Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil. ivna@bio.fiocruz.br
authors: I A F B
authors: IA
authors: Silveira
authors: R C
authors: RC
authors: Bastos
authors: M S
authors: MS
authors: Neto
authors: A P
authors: AP
authors: Laranjeira
authors: E F
authors: EF
authors: Assis
authors: S A R
authors: SA
authors: Fernandes
authors: M L
authors: ML
authors: Leal
authors: W C
authors: WC
authors: Silva
authors: C-H
authors: CH
authors: Lee
authors: C E
authors: CE
authors: Frasch
authors: J M
authors: JM
authors: Peralta
authors: E
authors: E
authors: Jessouroun
mesh_terms: D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood; D000915:Antibody Affinity; D004306:Dose-Response Relationship, Immunologic; D004355:Drug Stability; D005374:Filtration / Q000379:methods; D007074:Immunoglobulin G / Q000097:blood; D022401:Meningococcal Vaccines / Q000737:chemistry / Q000276:immunology* / Q000302:isolation & purification / Q000633:toxicity; D051379:Mice; D050296:Microbial Viability; D013745:Tetanus Toxoid / Q000737:chemistry / Q000276:immunology* / Q000378:metabolism
chemical_list: D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022401:Meningococcal Vaccines; D013745:Tetanus Toxoid; C410218:serogroup C meningococcal conjugate vaccine