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.

Comparative study of a whole-cell pertussis vaccine and a recombinant acellular pertussis vaccine / Podda, A.; CARAPELLA DE LUCA, E.; Contu, B.; Furlan, R.; Maida, A.; Moiraghi, A.; Stramare, D.; Titone, L.; Uxa, F.; DI PISA, F.; Peppoloni, Samuele; Nencioni, L.; RAPPUOLI R., AND THE ITALIAN MULTICENTER GROUP FOR THE STUDY OF RECOMBINANT ACELLULAR PERTUSSIS VACCINE. - In: THE JOURNAL OF PEDIATRICS. - ISSN 0022-3476. - STAMPA. - 124 (6)(1994), pp. 921-926.

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