PEDIATRICS Vol. 96 No. 3 September 1995, pp. 547-548
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Multicenter Acellular Pertussis Vaccine Trial: A National Institutes of Health Perspective

David L. Klein PhD1

1 Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD

The Pertussis Program within the Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, is responsible for the development, management, and monitoring of several research and training initiatives in the field of pertussis. As directed by Congress through the National Childhood Injury Act, and with support by the National Vaccine Program Office, the NIAID has a mandate to accelerate scientifically and systematically the development and clinical testing of new candidate acellular pertussis vaccines, with the goal of licensure of an improved product that is less reactogenic than, and equally effective as, conventional whole-cell vaccine. A major portion of this activity is done through contracted Vaccine Treatment and Evaluation Units (VTEUs) in the form of phase I and II clinical trials. Much of this effort involves close collaboration with vaccine manufacturers and the US Food and Drug Administration (FDA). The success of the NIAID's vaccine evaluation program has relied heavily on this unique interaction with industry during the past 14 years, which has proved beneficial for all parties. Furthermore, this interaction has provided vaccines and antigens for use in the clinical setting and the laboratory, respectively, promoting the rapid evaluation and testing of many of these products.

Although the conventional whole-cell pertussis vaccine used in the United States is efficacious in preventing disease, there is concern about its safety. Recent advances in the characterization of the antigenic and biologically active components of Bordetella pertussis have allowed for the development and production of a new generation of more highly purified acellular vaccines, which we hope will prove to be much safer.




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