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Kul Bhushan, SS Nair & KT Ganapathy: Indian J TB 1970, 17, 18-31.

The conventional methods of assessment of post-vaccination allergy by doing tuberculin testing among the vaccinated group are inapplicable in case of BCG vaccination without prior tuberculin test (Direct BCG). Because of obvious technical and operational advantages of direct BCG vaccination a search for a method of technical assessment of BCG vaccination is important. Hence, a study was carried out by the BCG Assessment Team of National Tuberculosis Institute in Tumkur district of Mysore state where Mass BCG Campaign was going on. Four groups of persons aged 0-20 years, each group belonging to two BCG Technicians area and vaccinated one day prior to visit of assessment team, were randomly selected. Besides, persons (0-20 years) from 2 unvaccinated villages of adjacent area were included as control groups. All persons were registered simultaneously tuberculin tested with 1 TU RT 23 and 5 TU RT 22 within 24 hours of BCG vaccination (for pre-vaccination allergy) and retested with tuberculin 5 TU RT 22 at the end of 3 weeks and 3 months (for post-vaccination allergy). The four vaccine groups were vaccinated with vaccine batch Nos. 977, 978, 981 and 984 respectively. Classification of the directly vaccinated persons into previously infected and non-infected by tuberculin test administered within 24 hours of vaccination and about 12 weeks later, elicitation of post-vaccination allergy only among the non-infected, has been considered as the Reference Test for judging the suitability of other methods of assessment studied. The main findings are: (1) The Reference Test showed that the four batches of BCG vaccine used had induced varying levels of allergy. (2) Assessment based on the mean size of post-vaccination reactions among 0-4 years age group, which consists predominantly of previously non-infected persons, showed a different pattern of differences between the four batches of vaccine as compared to the Reference Test. Moreover, to get adequate number of children aged 0-4 years, it will be necessary to cover a comparatively large population. (3) The method of using the mean size of post-vaccination reactions among those classified as non-infected on the basis of vaccination reactions of size 0-13 mm at the site of BCG vaccination on the 4th day of vaccination showed results similar to the Reference Test. But this method has only a marginal operational advantage over the Reference Test. (4) Using size of induration at the site of vaccination on 21st day of vaccination did not give the same results as the Reference Test. Operationally this method would have been most suitable as it involved only one visit to the group. (5) Differences between mean size of post-vaccination tuberculin reactions among directly vaccinated persons and mean size of (natural) allergy in reactors among neighbouring unvaccinated areas showed the same results as the Reference Test. This method has the operational advantage but needs further investigations. (6) Tuberculin testing of all directly BCG vaccinated persons including the natural reactors about 12 weeks after vaccination compared favourably, with the reference method, as the tuberculin reactors contributed less than 1 mm over and above the allergy in the vaccinated non-reactors . This method would be useful when rate of tuberculin reactors is less than 20% in 0-20 years age group and their mean size is also less than 20 mm. Operationally, it is a simpler method next only to No.4 above. Further investigations are considered necessary for final selection of this or any of the other methods.