[Results of the BCG vaccination in Hungary since 1929: evaluation of preventive and immunotherapeutic effectiveness].
BACKGROUND
The BCG (Bacille Calmette-Guérin), a living attenuated bacterial vaccine with a characteristic residual virulence, has been used to prevent tuberculosis since 1921 (in Hungary non-systematically since 1929) and applied for immunostimulation in neoplasia since the 1960s.


METHODS
Considering the grave tuberculosis epidemiological situation in Hungary, the BCG revaccination became compulsory up to 20 years old tuberculin negatives since 1959. The Pasteur P1173P2 BCG strain has been used for vaccine manufacturing with improved quality control methods according to the requirements of the WHO. With in systematic BCG primo and revaccination policy 8.1 million BCG vaccination from 1959 to 1983 then further 3.1 million between 1984 and 1996 have been performed.


RESULTS
Linear regression analysis demonstrates that the decrease of the TB incidence in children was 3-5 times more rapid (annual average decrease was 25.5%) than in adult since 1959. Multiple regression analysis indicates that the BCG is the strongest explanatory variable decreasing children TB incidence among other antituberculosis measures. The BCG vaccination efficacy ins demonstrated by 2 x 2 table analysis. The systematic BCG vaccination, the living and persisting BCG in the macrophages, confers acquired resistance against virulent TB infections. The immunostimulation in neoplasia has been applied with concentrated BCG developed in Hungary since 1979. The adverse reactions are at accepted frequency. The number of BCG vaccinated subjects was estimated at 1.5 billion from 1948 to 1974 in the world. The yearly number of BCG vaccination in the WHOI-EPI System is estimated 50-100 million.


CONCLUSIONS
The efficacy of the BCG vaccination can only be ensured if the vaccine is manufactured and controlled with standardized methods, and applied in a systematic vaccination programme. The effectiveness has to be evaluated in statistically valid biostatistical models.
Országos Közegészségügyi Intézet, Budapest.
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Lugosi
D000293:Adolescent; D000328:Adult; D001500:BCG Vaccine / Q000266:history*; D002648:Child; D002675:Child, Preschool; D049673:History, 20th Century; D006801:Humans; D006814:Hungary / Q000453:epidemiology; D007115:Immunization Schedule; D007223:Infant; D016014:Linear Models; D014376:Tuberculosis / Q000453:epidemiology* / Q000266:history / Q000276:immunology; D014611:Vaccination / Q000266:history*; D014613:Vaccines, Attenuated
D001500:BCG Vaccine; D014613:Vaccines, Attenuated