title: Comparison of serological results in the NIAID Multicenter Acellular Pertussis Trial with recent efficacy trials.
abstract: Comparison of the serological results from the NIAID-funded Multicenter Acellular Pertussis Trial (MAPT) and the efficacy trials are complicated by differences in assay methods, immunization schedules, vaccine lots and populations immunized. In spite of these differences, serological results closely approximating those obtained in the MAPT were found for most or all of the assayed antibodies in the Mainz and Erlangen studies. Serological results for some of the antigens included in the vaccines used in the Italian and Stockholm trials were similar to the MAPT results, while significant differences were noted with other antigens. Differences in immunization schedules and serological assay methods made comparisons between MAPT and the Gothenburg and Senegal trials more difficult. Our understanding of the efficacy trial results, and our ability to apply those results to the U.S. population, would be enhanced markedly by simultaneous re-analysis of stored sera from MAPT and selected efficacy trials. This goal should be given priority by the study organizers and sponsors.
authors.affiliation: Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Edwards
authors.forename: M D
authors.initials: MD
authors.lastname: Decker
mesh_terms: D002986:Clinical Trials as Topic; D017326:Clinical Trials, Phase III as Topic; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D006801:Humans; D007223:Infant; D015337:Multicenter Studies as Topic; D009316:National Institutes of Health (U.S.); D012698:Serologic Tests; D014481:United States; D014917:Whooping Cough / Q000175:diagnosis / Q000517:prevention & control*
chemical_list: D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines