PEDIATRICS Vol. 96 No. 3 September 1995, pp. 548-557
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Comparison of 13 Acellular Pertussis Vaccines: Overview and Serologic Response

Kathryn M. Edwards MD1, Bruce D. Meade PhD2, Michael D. Decker MD, MPH3, George F. Reed PhD4, Margaret B. Rennels MD5, Mark C. Steinhoff MD6, Edwin L. Anderson MD7, Janet A. Englund MD8, Michael E. Pichichero MD9, Maria A. Deloria BS4, and Adamadia Deforest PhD10

1 Department of Pediatrics, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD
2 Department of Division of Bacterial Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD
3 Preventive Medicine, and Medicine, Vanderbilt University School of Medicine, Nashville, TN
4 Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, Bethesda, MD
5 Department of Pediatrics and the Center for Vaccine Development, University of Maryland School of Medicine, Baltimore
6 Departments of International Health and Pediatrics, Johns Hopkins University, Baltimore
7 Department of Medicine, St Louis University School of Medicine
8 Departments of Microbiology and Immunology and Pediatrics, Baylor College of Medicine, Houston, TX
9 Department of Pediatrics, University of Rochester School of Medicine, Rochester, NY
10 Departments of Microbiology and Pediatrics, Temple University School of Medicine, and St Christopher's Hospital for Children, Philadelphia

Objective. To compare the immunogenicity of a licensed conventional whole-cell (WCL) and 13 diphtheria-tetanus-acellular pertussis (DTaP) vaccines that differed in source, method of manufacture, and included antigens; all vaccines included diphtheria and tetanus toxoids.

Methods. Healthy infants were enrolled through six university-based vaccine and treatment evaluation units and were randomized to receive one of the study vaccines at 2, 4, and 6 months of age. Sera were obtained before the first immunization and 1 month after the third immunization and were analyzed for antibody to pertussis toxin (PT), filamentous hemagglutinin, fimbriae, pertactin, and diphtheria and tetanus toxins. Chinese hamster ovary cell toxin neutralization assays were performed, and levels of agglutinating antibodies were determined.

Results. Of 2342 infants enrolled, 1942 contributed usable preimmunization and postimmunization serum specimens. Each vaccine produced significant increases in antibodies directed against the included antigens; postimmunization antibody titers differed significantly among the DTaP vaccines. For each evaluated antigen, the majority of DTaP vaccines produced antibody responses that equaled or exceeded those produced by WCL. For some antigens (eg, PT), mean antibody levels by vaccine correlated poorly with the quantity of antigen included in each vaccine; for others (eg, fimbriae), there was a close correlation.

Conclusion. Although serologic correlates of pertussis immunity are not defined, it is clear that DTaP vaccines can stimulate immune responses that exceed those of licensed whole-cell vaccine with respect to the measured antibodies. Particularly for PT, immunogenicity seems to depend on factors in addition to antigen concentration, possibly including antigen derivation and formulation. No DTaP was most or least immunogenic with respect to all included antigens.




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