Characterization and immunogenicity of meningococcal group C conjugate vaccine prepared using hydrazide-activated tetanus toxoid.
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.
Silveira
I A F B
IA
Laboratório de Tecnologia Bacteriana, Bio-Manguinhos, Fundação Oswaldo Cruz, Rio de Janeiro, Brazil. ivna@bio.fiocruz.br
Bastos
R C
RC
Neto
M S
MS
Laranjeira
A P
AP
Assis
E F
EF
Fernandes
S A R
SA
Leal
M L
ML
Silva
W C
WC
Lee
C-H
CH
Frasch
C E
CE
Peralta
J M
JM
Jessouroun
E
E
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
D000907:Antibodies, Bacterial; D007074:Immunoglobulin G; D022401:Meningococcal Vaccines; D013745:Tetanus Toxoid; C410218:serogroup C meningococcal conjugate vaccine