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Diphtheria-tetanus-pertussis (DTP) combination vaccines and evaluation of pertussis immune responses

Fabrice Godfroid1, Philippe Denoël, Dany de Grave

  • 1Research & Development, GlaxoSmithKline Biologicals, Rue de l'Institut 89, B-1330 Rixensart, Belgium.

International Journal of Medical Microbiology : IJMM
|November 10, 2004
PubMed

Insights

New combination vaccines for diphtheria, tetanus, and pertussis (DTP) show comparable immune responses to separate vaccines. A mouse model effectively predicts clinical efficacy for these DTP vaccines.

Area of Science:

  • Immunology
  • Vaccinology
  • Microbiology

Background:

  • Diphtheria-tetanus-pertussis (DTP) combination vaccines, using either whole-cell (DTPw) or acellular (DTPa) pertussis components, simplify vaccine schedules and allow co-administration with other vaccines like pneumococcal conjugates.
  • Assessing the safety and immunogenicity of these combination vaccines is crucial to ensure they are non-inferior to individually administered vaccines.
  • While antibody levels are used as correlates of protection for many vaccines, established correlates for pertussis are lacking, complicating efficacy assessments.

Purpose of the Study:

  • To clinically evaluate DTPa- and DTPw-based combination vaccines.
  • To demonstrate the immunological non-inferiority of these combinations compared to their separately administered licensed counterparts.
  • To validate a Bordetella pertussis mouse lung clearance model as a predictor of clinical efficacy for DTP vaccines.

Main Methods:

  • Clinical evaluation of DTPa- and DTPw-based combination vaccines.
  • Assessment of immunological non-inferiority through antibody response evaluations, including vaccine response rates, geometric mean concentrations (GMCs) for anti-pertussis toxin (PT), anti-fimbrial protein (FHA), anti-pertactin (PRN), and anti-B. pertussis (BPT).
  • Utilized reverse cumulative distribution curves and a B. pertussis mouse lung clearance model.

Main Results:

  • DTPa- and DTPw-based combination vaccines demonstrated immunological non-inferiority compared to their separately administered licensed vaccines.
  • Various immunological parameters, including antibody GMCs and response rates against key pertussis antigens, supported the non-inferiority findings.
  • The B. pertussis mouse lung clearance model proved capable of predicting the clinical efficacy of licensed DTPa and DTPw vaccines.

Conclusions:

  • DTP combination vaccines are immunologically non-inferior to separate DTP vaccines, supporting their use for simplified vaccination schedules.
  • The evaluated immunological assays provide robust data for assessing pertussis vaccine responses.
  • The B. pertussis mouse lung clearance model is a valuable tool for evaluating the efficacy of new DTP combination vaccines.

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