Open AccessSafety and preliminary immunogenicity of MenC/P64k, a meningococcal serogroup C conjugate vaccine with a new recombinant carrier
Author(s) -
Pérez Antonio E.,
Dickinson Félix O.,
Banderas Francisco,
Serrano Teresita,
Llanes Rafael,
Guzmán Daymi,
Díaz Pablo,
Alvarez Anabel,
Guirola María,
Caballero Evelin,
CanaanHaden Leonardo,
Guillén Gerardo
Publication year - 2006
Publication title -
fems immunology & medical microbiology
Language(s) - English
Resource type - Journals
eISSN - 1574-695X
pISSN - 0928-8244
DOI - 10.1111/j.1574-695x.2006.00047.x
Subject(s) - immunogenicity , conjugate vaccine , meningococcal vaccine , recombinant dna , conjugate , titer , virology , neisseria meningitidis , meningococcal disease , medicine , antigen , microbiology and biotechnology , immunology , biology , antibody , immunization , bacteria , mathematical analysis , biochemistry , genetics , mathematics , gene
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.