Abstract

This paper attempts to summarizes possible reasons for BCG trial failure in India. It also lists out some of the important controversies and questions raised with regards to BCG trial in the context of Non Specific sensitivity. It emphasizes on the fact, that Tuberculin test does not accurately reflect individual’s responded immunologically to mycobacterium, it only indicates nature of immune response that has been elicited in an infected individual. The dynamics of tuberculin reaction needs to be understood through immunological considerations. Categorization of Tuberculin test results factoring in immunological considerations,will have great implication on the interpretation of tuberculin test and therefore on the estimation of annual risk of infection of tuberculosis.

Highlights

  • Failure of BCG vaccine to protection in India against pulmonary tuberculosis gave rise plethora of controversy over the design and conduct of the study [1]

  • There still lingering questions over the possibility of role played by Non Specific Sensitivity [NSS] caused through environmental atypical mycobacterium infection possibly masking the protective effect of BCG in the trial area continue to be debated. [2, 3]

  • Design and Outcome of BCG Trial In India. This BCG trial was organised by the Indian Council of Medical Research (ICMR) in collaboration with the WHO and Centres for Disease Control (CDC), US Public Health Services

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Summary

Introduction

Failure of BCG vaccine to protection in India against pulmonary tuberculosis gave rise plethora of controversy over the design and conduct of the study [1]. To give the readers the context of NSS and the controversies surrounded, a brief overview of BCG trial in India is presented below. 2) All earlier controlled human trials were conducted with hesh liquid vaccines and not freezed dried vaccine that was extensively being used tubeculosis control programme in various countries. 3) Expert group that reviewed these BCG trials carried outside India opined that the differences in efficacy of BCG was probably due to [5]: i) Dose and strength of the vaccine ii) Prevalence of NSS infection in certain areas and this infection showing protection in animal experiment. There still lingering questions over the possibility of role played by Non Specific Sensitivity [NSS] caused through environmental atypical mycobacterium infection possibly masking the protective effect of BCG in the trial area continue to be debated. [2, 3]

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