Acellular pertussis vaccine composed of genetically inactivated pertussis toxin: Safety and immunogenicity in 12- to 24- and 2- to 4-month-old children

• Published in: The Journal of pediatrics Vol. 120; no. 5; pp. 680 - 685
• Main Authors: Podda, Audino, De Luca, Erminia Carapella, Titone, Lucina, Casadei, Anna Maria, Cascio, Antonio, Peppoloni, Samuele, Volpini, Gianfranco, Marsili, Ilio, Nencioni, Luciano, Rappuoli, Rino
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.05.1992; Elsevier
• Subjects: Antibodies, Bacterial - immunology; Antibody Formation - immunology; Biological and medical sciences; Bordetella pertussis - immunology; Drug Evaluation; Enzyme-Linked Immunosorbent Assay; Humans; Immunomodulators; Infant; Medical sciences; Pertussis Toxin; Pertussis Vaccine - adverse effects; Pertussis Vaccine - immunology; Pharmacology. Drug treatments; Vaccination; Vaccines, Synthetic; Virulence Factors, Bordetella; Whooping Cough - immunology; Whooping Cough - prevention & control; Human; Infection; Immunogenicity; Vaccination; Bacteriosis; Infant; Child; Whooping cough
• ISSN: 0022-3476; 1097-6833
• DOI: 10.1016/S0022-3476(05)80227-6

To determine whether a nontoxic derivative of pertussis toxin obiained by recombinant DNA technology, PT-9K/129G, is a good candidate for a new pertussis vaccine, we examined the safety and the immunogenicity in children of a vaccine containing 15 μg of PT-9K/129G protein and 0.5 mg of aluminum hydroxide per dose. Fifty-three children 12 to 24 months of age and 21 infants aged 2 to 4 months were injected with two and three doses, respectively. The vaccine did not incude significant local or systemic reactions and elicited an increase of antibody titer in more than 98% of the children. The geometric mean of the toxin-neutralizing titers increased after each dose and was 85 units in children given two doses and 196 units in those given three doses. Two children who had detectable antibody levels before the first immunization had a high response (>320 units) to the first vaccine dose. The findings suggest that PT-9K/129G is a promising antigen to be included in the development of acellular pertussis vaccines.