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THE EFFICACY OF BCG VACCINATION A BRIEF REPORT OF
THE CHINGLEPUT BCG TRIAL |
GVJ Baily: NTI Newsletter 1980, 17, 108-18. |
Even though BCG has been in use for last 60 years,
it has always been the subject of controversy, as several scientific
studies done all over the world showed the protective value of
BCG varying from 0 percent to 80. Because of the controversy
over its protective effect and its extensive use in India it was
felt necessary to undertake further field trials, wherein all shortcomings
of previous trials could be eliminated. The Government of India
took the decision to undertake a BCG trial in India. In 1968, the
study was carried out in Chingleput district in Tamil Nadu, where
no BCG vaccination was previously offered. The objective
of the study were to obtain i) precise estimate of the protective
effect of BCG vaccination against tuberculosis in the non-infected,
ii) effect of BCG vaccination in persons already infected and iii)
protective effect of different strains of BCG and iv) epidemiological
data on tuberculosis in the community. The entire population of
3,60,000 persons were registered during a period of two and
a half years of intake. All the persons aged one month and above
were randomly divided into three main groups. One group vaccinated
with the Madras vaccine, the second with Paris vaccine
and the third with Placebo. At the same time all persons
were tested with tuberculin, those above 10 years and above were
X-rayed and those having X-ray shadows were examined by direct smear
and culture. The study population was systematically and intensively
followed up by X-ray and sputum examinations to diagnose all the
new cases occurring in the community. The protective effect of BCG
vaccination is defined as the proportionate reduction in the occurrence
of new cases among the vaccinated, initially tuberculin negatives
as compared to a similar but unvaccinated group. The protective
effect was studied among individuals who were not previously infected,
who had no tuberculosis at the time of vaccination and who were
either vaccinated or left unvaccinated. The results of 7½
years of follow up showed that the number of new cases that
occurred among the group vaccinated by either of the vaccines or
from the unvaccinated group were similar. This showed that BCG
vaccination did not offer any protection against tuberculosis of
the lung. The epidemiological characteristics of the population
were high prevalence and incidence of tuberculosis infection and
disease and high prevalence of non- specific sensitivity. The risk
of manifest disease for this recently infected was relatively small,
as most of the new cases occurred among those who were tuberculin
positive at the time of intake and not from those who were not infected
then. Implications : Several expert committees appointed
both by the authorities in India and by the WHO have examined all
the procedures followed up in the study and came to the conclusion
that the study had been meticulously carried out and vaccine used
in the trial were the best available ones. The implications of this
study was 'should BCG vaccination be given up in India?' Yet another
committee appointed jointly by ICMR and the WHO went into the epidemiological
aspects of the causation of tuberculosis under Indian conditions
and concluded that BCG may not protect against tuberculosis of lung
which occurs mostly in adults; it could provide substantial protection
against childhood form of tuberculosis such as tubercular meningitis,
tuberculosis of bones & joints etc. The protective effect of
BCG against these forms of tuberculosis was not studied in Chingleput
Trial. In India BCG vaccination is recommended to be given at an
early age preferably before the end of the first year after birth.
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KEY WORDS: EFFICACY, BCG VACCINE, MADRAS VACCINE,
FRENCH VACCINE, CHINGLEPUT BCG TRIAL. |