title: Comparative study of a whole-cell pertussis vaccine and a recombinant acellular pertussis vaccine. The Italian Multicenter Group for the Study of Recombinant Acellular Pertussis Vaccine.
abstract: The safety and immunogenicity of an acellular pertussis vaccine containing the genetically detoxified pertussis toxin PT-9K/129G, filamentous hemagglutinin, and pertactin, together with diphtheria and tetanus toxoids, were compared with those of a whole-cell pertussis component-diphtheria-tetanus vaccine. Four hundred eighty infants were enrolled into this prospective, multicenter, double-blind study. Each infant was randomly given three doses of one of the two vaccines at 2, 4, and 6 months of age. Both local and systemic adverse reactions, reported within 48 hours and 7 days of each injection, were less frequent after the acellular vaccine than after the whole-cell vaccine. The enzyme-linked immunosorbent assay titers to pertussis toxin, filamentous hemagglutinin, and pertactin, as well as the pertussis toxin-neutralizing titer measured by the Chinese hamster ovary cell assay, were significantly higher after the acellular vaccine was given. Both vaccines induced adequate levels of anti-diphtheria and anti-tetanus antibodies. We conclude that the recombinant acellular pertussis vaccine produces fewer reactions than the whole-cell vaccine and provides a high antibody response against the antigens of Bordetella pertussis involved in bacterial adhesion and systemic toxic effects.
authors.affiliation: Biocine R & D Vaccines, Siena, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Podda
authors.forename: E C
authors.initials: EC
authors.lastname: De Luca
authors.forename: B
authors.initials: B
authors.lastname: Contu
authors.forename: R
authors.initials: R
authors.lastname: Furlan
authors.forename: A
authors.initials: A
authors.lastname: Maida
authors.forename: A
authors.initials: A
authors.lastname: Moiraghi
authors.forename: D
authors.initials: D
authors.lastname: Stramare
authors.forename: L
authors.initials: L
authors.lastname: Titone
authors.forename: F
authors.initials: F
authors.lastname: Uxa
authors.forename: F
authors.initials: F
authors.lastname: Di Pisa
authors.forename: S
authors.initials: S
authors.lastname: Peppoloni
mesh_terms: D000907:Antibodies, Bacterial / Q000096:biosynthesis; D001886:Bordetella pertussis / Q000276:immunology*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000009:adverse effects / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010567:Pertussis Vaccine / Q000009:adverse effects / Q000276:immunology; D011446:Prospective Studies; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D010567:Pertussis Vaccine; D014614:Vaccines, Synthetic