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The Indian Journal of Tuberculosis Vol. 47 New Delhi, January, 2000 No. 1 Editorial BCG REVISITED BCG vaccine is in the news again. Results of the 15-year follow-up of the Chingleput BCG efficacy trial conducted by ICMR’s Tuberculosis Research Centre were published recently 1 . Some termed the re- sults as the “the great Madras failure” while others called them “the great BCG hoax”. Editorials in news-  papers questioned the continued inclusion of BCG in the immunization programme. Concerns were echoed in the Parliament too! The 15-year follow up results merely confirmed what was known since 1980, when results of the 7 1/ 2 - year follow-up of the same study were published 2 . BCG offered no overall protection against adult type  bacillary tuberculosis and a low level of overall protection (27%, 95% CI - 8 to 50%) in children.  Ever since BCG was first used (in 1921) as an anti-tuberculosis vaccine in humans, doubts concerning its efficacy have been raised repeatedly, but proper efficacy evaluation did not begin until 1930s. In the randomized controlled clinical trials of BCG vaccine carried out since then, its protective efficacy against tuberculosis has varied from 0 to 80%, in different populations 3 . In general, the protective efficacy was found to be greater in trials conducted in northern latitudes, where tuberculosis prevalence is low compared with studies elsewhere. Observational studies, including those in contacts and populations have confirmed the variability in the level of protection. Variability in protective efficacy has been observed not only in the different trials but also between sites of the disease. However, a meta-analysis has shown that summary BCG protective effect against miliary tuberculosis or tuberculous meningitis in randomized control trials was 86%, and in case control studies it was 75% 4 . Further, case control studies carried out in India (not included in the quoted meta-analysis) also show a protective efficacy of BCG against tuberculous meningitis of not less than 75%.  It is precisely because of the beneficial effect that the continued use of BCG among infants in immuni- zation programme has been recommended. The current strategy is for only one BCG vaccination at birth. To date, there is no evidence that repeat BCG vaccination or boosters increase the protection.  A major issue affecting BCG vaccination is the duration of protection. A quantitative review of annual change in efficacy in ten randomized trials of BCG has shown that even when BCG gives good initial  protection, it may wane with the time, at a rate corresponding to 5% to 14% annual decrease in the rate ratio of tuberculosis in unvaccinated compared to vaccinated individuals 5 . Published data do not provide evi- dence of the protective effect of BCG beyond ten years after vaccination. This observation is critical, when trying to assess the value of BCG vaccination as part of a tuberculosis control programmes because BCG is given in infancy while the major burden of the disease is in adulthood.  There is, therefore, an urgent need for an improved vaccine which does what BCG fails to do.  The availability of the whole genome sequence of  M.tuberculosis, which provides access to the entire antigenic and epitopic repertoire, coupled with better understanding of cellular immunity, the availability of  cytokine assays for epidemiologic studies and significant advances in mycobacterial research, using mod- ern tools, provides an ideal platform to launch a new vaccine or an improved possibility of developing better  vaccine candidates. As alternatives to BCG, there are several exciting experimental approaches, including rationally attenuated M.tuberculosis, recombinant BCG, over-expressing M.tuberculosis antigens, protein 

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