Study on efficacy and improvement of diphtheria and tetanus toxoids and pertussis (DPT) vaccine

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Purified component (acellular) Bordetella pertussis (aP) vaccines were first developed in Japan. Their emergency introduction to the nation 20 years ago made prospective double blind efficacy trial difficult. In order to obtain reliable domestic data on their efficacy, we conducted a case control study using WHO's case definition of pertussis in the City of Kitakyushu where the two-component Kaketsuken aP vaccine combined with diphtheria and tetanus toxoids (DTaP) has been exclusively used since 1991.Among 116 cases registered during the investigation period, 16 fulfilled the definition. Based on the data of the confirmed cases and their age-matched controls, the efficacy of Kaketsuken aP vaccine was estimated to be 87.4 % and comparative to the data of Japanese aP vaccines obtained in European countries. The risk of pertussis in children who had received less than two doses of DTaP vaccine was 7.39 times higher than that of children who had two or more doses.DTaP vaccine was injected to a total of 186 adolescents and adults to evaluate its safety for these age groups, Forty-four persons were 10-19 years of age (Group A) and 142 persons were 20 years of age or older (Group B). Each one case in both groups showed swelling of more than 5 cm in diameter around the injection site. One case in Group A and 3 cases in group B had swelling of 1-5 cm in diameter. Systemic adverse reactions were not observed.