Preliminary Report on Household Contact Studies of the Prevention of Pertussis in Japanese Children by Takeda Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Combined(I. Current Situation of Acellular Pertussis Vaccines)(Clinical Aspects of Acellular Pertussis Vaccines)

  • MORTIMER Edward A. Jr.
    Department of Epidemiology and Biostatistics, School of Medicine, Case Western Reserve University

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Acellular pertussis vaccines combined with diphtheria and tetanus toxoids and adsorbed onto an aluminum salt (AcPDT) have been used exclusively in Japan for the immunization of children since 1981. (Interagency Report, 1987; Kimura et al., 1985) Immunization of children is initiated at two years of age with a booster dose one year later. Morbidity and mortality rates from pertussis, which had steadily increased since 1975 because of poor acceptance of the whole cell preparation, have declined since widespread use of AcPDT (Kimura, 1985). The apparent efficacy of AcPDT has also been demonstrated by several household contact studies in which rates of pertussis in immunized and unimmunized children exposed to the disease in their own homes were determined. In these studies vaccine efficacy ranged between 78 and 93 percent (Interagency Report). However, there are six different manufacturers of AcPDT in Japan, and their products vary in antigenic constituents. One manufacturer produces AcPDT that contains about 50 percent pertussis toxoid and 50 percent filamentous hemagglutinin (B-type AcPDT). Four manufacturers market vaccines that contain predominantly FHA, approximately 10 percent pertussis toxoid, and approximately one percent agglutinogens (T-type AcPDT). The sixth product comprises pertussis toxoid and FHA in amounts that are intermediate between the B- and T-types. With the exception of one small study (Aoyama, 1988) all of the Japanese studies have considered these AcPDT products as a group, and accordingly product-specific information concerning efficacy is not available. The present study was designed to determine the clinical efficacy of a single T-type product, produced by Takeda Chemical Industries and containing 90 percent FHA, 9 percent pertussis toxoid and 1 percent agglutinogens. The frequency of clinical pertussis following household exposure was determined in children who had been previously immunized with this product and compared with that in previously unimmunized, exposed children. About ten million doses of this particular product have been used since 1981, which currently enjoys about 30 percent of the market in Japan.

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