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Safety and preliminary immunogenicity of the recombinant outer membrane protein P64k of Neisseria meningitidis in human volunteers
Author(s) -
Pérez Antonio,
Dickinson Félix,
Cinza Zurina,
Ruíz Aroldo,
Serrano Teresita,
Sosa Jorge,
González Sonia,
Gutiérrez Yainelis,
Nazábal Consuelo,
Gutiérrez Oderay,
Guzmán Daymi,
Díaz Manuel,
Delgado Maité,
Caballero Evelin,
Sardiñas Gretel,
Alvarez Anabel,
Martín Alejandro,
Guillén Gerardo,
Silva Ricardo
Publication year - 2001
Publication title -
biotechnology and applied biochemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.468
H-Index - 70
eISSN - 1470-8744
pISSN - 0885-4513
DOI - 10.1042/ba20010029
Subject(s) - immunogenicity , recombinant dna , neisseria meningitidis , antigen , immune system , virology , microbiology and biotechnology , antibody , immunology , adverse effect , neisseriaceae , titer , biology , medicine , pharmacology , bacteria , antibiotics , gene , biochemistry , genetics
P64k is a meningococcal protein from Neisseria meningitidis that has been obtained by recombinant DNA technology. Recombinant P64k has been extensively characterized by physicochemical and immunological methods. Lately this protein has been found to act as a versatile immunological carrier for weak antigens in mice. In the present work, a Phase I clinical trial was carried out in healthy volunteers who received three inoculations of either placebo or recombinant P64k (20 or 50 μ g). No severe adverse events occurred during the trial. Only mild adverse events in ten volunteers were observed. At 1 month after the third dose, 15 out of 18 volunteers (83.3%) who received the recombinant antigen had a P64k‐specific antibody titre 1:100, as detected by ELISA. A fourth dose, given 9 months after the third one, elicited a potent booster immune response in P64k vaccinees. Accordingly, these P64k formulations were considered safe and immunogenic in healthy human volunteers.