Safety and preliminary immunogenicity of MenC/P64k, a meningococcal serogroup C conjugate vaccine with a new recombinant carrier.
This study reports the preliminary assessment of the safety and immunogenicity of the first serogroup C conjugate vaccine candidate that includes meningococcal P64k recombinant protein as the carrier (MenC/P64k). Twenty volunteers were recruited for a double-blind, randomized, controlled phase I clinical trial, receiving a single dose of MenC/P64k (study group) and a single dose of the commercial polysaccharide vaccine AC (control group). Only mild reactions were observed. No statistical differences were detected between the antipolysaccharide C IgG responses of both groups as well as between bactericidal serum titre (P > 0.05). The MenC/P64k vaccine was found to have a good safety profile, to be well tolerated and immunogenic.
Pérez
Antonio E
AE
Tropical Medicine Institute Pedro Kourí, Havana, Cuba. antonio@ipk.sld.cu
Dickinson
Félix O
FO
Banderas
Francisco
F
Serrano
Teresita
T
Llanes
Rafael
R
Guzmán
Daymi
D
Díaz
Pablo
P
Alvarez
Anabel
A
Guirola
María
M
Caballero
Evelin
E
Canaan-Haden
Leonardo
L
Guillén
Gerardo
G
D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001425:Bacterial Outer Membrane Proteins / Q000276:immunology*; D003168:Complement Fixation Tests; D003462:Cuba; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000276:immunology* / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
D000907:Antibodies, Bacterial; D001425:Bacterial Outer Membrane Proteins; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate; C112623:lpdA protein, Neisseria meningitidis