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A controlled trial of two acellular vaccines and one whole-cell vaccine against pertussis. Progetto Pertosse Working Group.
- Source :
-
The New England journal of medicine [N Engl J Med] 1996 Feb 08; Vol. 334 (6), pp. 341-8. - Publication Year :
- 1996
-
Abstract
- Background: Concern about both safety and efficacy has made the use of whole-cell pertussis vaccines controversial. In some European countries, including Italy, the rate of vaccination against pertussis is low.<br />Methods: We conducted a double-blind trial in Italy in which infants were randomly assigned to vaccination at two, four, and six months of age with an acellular pertussis vaccine together with diphtheria and tetanus toxoids (DTP); a DTP vaccine containing whole-cell pertussis (manufactured by Connaught Laboratories); or diphtheria and tetanus toxoids without pertussis (DT). The acellular DTP vaccine was either one containing filamentous hemagglutinin, pertactin, and pertussis toxin inactivated with formalin and glutaraldehyde (SmithKline Beecham) or one with filamentous hemagglutinin, pertactin, and genetically detoxified pertussis toxin (Chiron Biocine). Pertussis was defined as 21 days or more of paroxysmal cough, with infection confirmed by culture or serologic testing.<br />Results: The efficacy of each vaccine, given in three doses, against pertussis was determined for 14,751 children over an average of 17 months, with cases included in the analysis if cough began 30 days or more after the completion of immunization. For both of the acellular DTP vaccines, the efficacy was 84 percent (95 percent confidence intervals, 76 to 89 percent for Biocine DTP and 76 to 90 percent for SmithKline DTP), whereas the efficacy of the whole-cell DTP vaccine was only 36 percent (95 percent confidence interval, 14 to 52 percent). The antibody responses were greater to the acellular vaccines than to the whole-cell vaccine. Local and systemic adverse events were significantly more frequent after the administration of the whole-cell vaccine. For the acellular vaccines, the frequency of adverse events was similar to that in the control (DT) group.<br />Conclusions: The two acellular DTP vaccines we studied were safe, immunogenic, and efficacious against pertussis, whereas the efficacy of the whole-cell DTP vaccine was unexpectedly low.
- Subjects :
- Antibodies, Bacterial blood
Antigens, Bacterial immunology
Antigens, Bacterial therapeutic use
Bordetella pertussis immunology
Diphtheria Toxoid therapeutic use
Diphtheria-Tetanus Vaccine
Diphtheria-Tetanus-Pertussis Vaccine therapeutic use
Double-Blind Method
Humans
Infant
Pertussis Toxin
Pertussis Vaccine adverse effects
Pertussis Vaccine immunology
Tetanus Toxoid therapeutic use
Treatment Outcome
Vaccines, Combined therapeutic use
Vaccines, Inactivated therapeutic use
Virulence Factors, Bordetella immunology
Virulence Factors, Bordetella therapeutic use
Pertussis Vaccine therapeutic use
Whooping Cough prevention & control
Subjects
Details
- Language :
- English
- ISSN :
- 0028-4793
- Volume :
- 334
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 8538704
- Full Text :
- https://doi.org/10.1056/NEJM199602083340601