title: Safety and preliminary immunogenicity of the recombinant outer membrane protein P64k of Neisseria meningitidis in human volunteers.
abstract: 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 microg). 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 > or =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.
authors.affiliation: Instituto de Medicina Tropical Pedro Kourí, Autopista Novia del Mediodía, Km 6 1/2, La Habana, Cuba. antonio@ipk.sld.cu
authors.forename: A
authors.initials: A
authors.lastname: Pérez
authors.forename: F
authors.initials: F
authors.lastname: Dickinson
authors.forename: Z
authors.initials: Z
authors.lastname: Cinza
authors.forename: A
authors.initials: A
authors.lastname: Ruíz
authors.forename: T
authors.initials: T
authors.lastname: Serrano
authors.forename: J
authors.initials: J
authors.lastname: Sosa
authors.forename: S
authors.initials: S
authors.lastname: González
authors.forename: Y
authors.initials: Y
authors.lastname: Gutiérrez
authors.forename: C
authors.initials: C
authors.lastname: Nazábal
authors.forename: O
authors.initials: O
authors.lastname: Gutiérrez
authors.forename: D
authors.initials: D
authors.lastname: Guzmán
authors.forename: M
authors.initials: M
authors.lastname: Díaz
authors.forename: M
authors.initials: M
authors.lastname: Delgado
authors.forename: E
authors.initials: E
authors.lastname: Caballero
authors.forename: G
authors.initials: G
authors.lastname: Sardiñas
authors.forename: A
authors.initials: A
authors.lastname: Alvarez
authors.forename: A
authors.initials: A
authors.lastname: Martín
authors.forename: G
authors.initials: G
authors.lastname: Guillén
authors.forename: R
authors.initials: R
authors.lastname: Silva
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000942:Antigens, Bacterial / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D001425:Bacterial Outer Membrane Proteins / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D009345:Neisseria meningitidis / Q000276:immunology*; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000942:Antigens, Bacterial; D001425:Bacterial Outer Membrane Proteins; D011994:Recombinant Proteins; C112623:lpdA protein, Neisseria meningitidis