INITIAL CLINICAL-TRIAL OF MYCOBACTERIUM-TUBERCULOSIS ANTIGEN-5 IN TUBERCULIN-POSITIVE HUMAN-SUBJECTS

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Abstract
A single lot of M. tuberculosis antigen 5 was used in graded doses to skin test 92 persons in a geographic area where nonspecific tuberculin reactivity is uncommon. In 47 tuberculin-positive subjects, antigen 5 had a potency of 2.7 tuberculin units/.mu.g. An intradermal dose of 0.50 .mu.g gave typical delayed skin test reactions in all of 15 tuberculin-positive subjects, with a mean reaction size of 15.17 mm. Some preparations of antigen 5 were unstable during lyophilization and storage; solutions of antigen 5 in diluent containing Tween 80 were stable. M. tuberculosis antigen 5 is a potent tuberculin skin test antigen deserving of further clinical evaluation.