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The multicenter acellular pertussis trial: an overview

M D Decker1, K M Edwards

  • 1Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, Tennessee 37232-2637, USA.

The Journal of Infectious Diseases
|November 1, 1996
PubMed

Insights

This study found that acellular pertussis vaccines, combined with diphtheria and tetanus toxoids, are safe and effective in infants. Acellular vaccines showed superior immunogenicity and fewer adverse reactions compared to whole cell pertussis vaccines.

Area of Science:

  • Pediatrics
  • Immunology
  • Vaccinology

Background:

  • Pertussis remains a significant public health concern, necessitating effective vaccination strategies.
  • Diphtheria and tetanus toxoids are commonly combined with pertussis vaccines for comprehensive infant immunization.
  • Evaluating novel acellular pertussis vaccine formulations is crucial for improving vaccine safety and immunogenicity.

Purpose of the Study:

  • To assess the safety and immunogenicity of 13 acellular pertussis vaccines compared to 2 whole cell pertussis vaccines.
  • To evaluate the immune response to pertussis antigens in infants receiving combined diphtheria, tetanus, and acellular or whole cell pertussis vaccines.

Main Methods:

  • A multicenter, randomized, double-blind study involving 2342 infants.
  • Vaccines administered at 2, 4, and 6 months of age.
  • Serum antibody levels measured before the first dose and one month after the third dose.

Main Results:

  • All 13 acellular pertussis vaccines demonstrated significant increases in antibody levels for included antigens.
  • Mean antibody levels for acellular vaccines frequently surpassed those of the reference whole cell vaccine.
  • Acellular pertussis vaccines were well-tolerated and associated with significantly fewer adverse reactions than whole cell vaccines.

Conclusions:

  • Acellular pertussis vaccines, when combined with diphtheria and tetanus toxoids, are safe and immunogenic in infants.
  • Acellular pertussis vaccines offer a favorable safety profile with enhanced immunogenicity compared to whole cell pertussis vaccines.

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