Comparative cutaneous testing with purified protein derivative and the antigen complex A60 in vaccinated subjects and tuberculosis patients.

Some 840 bacille Calmette-Guérin (BCG)-vaccinated healthy controls and tuberculosis patients from two Chinese hospitals were submitted to comparative skin tests with purified protein derivative of tuberculin (PPD; as reference) and with the antigen complex A60 from Mycobacterium bovis BCG. In a first trial, including 581 persons (185 healthy juveniles, 180 healthy adults and 216 tuberculosis patients), a limited dose of A60 (1 microgram) was used. Performance of the A60 test was similar to that of 5 I.U. PPD for controls (cut-off values = 5 mm induration diameter), but lower than that seen for tuberculosis patients (10 mm cut-off values). A second survey was conducted on 259 persons (109 recently revaccinated healthy persons, considered as tuberculin-negative in the first trial, and 150 tuberculosis patients), using a higher dose of A60 (2 micrograms) and the same dose of PPD (5 I.U.). Similar results were obtained with the two tests in all cases, thus supporting the possibility of PPD replacement by A60 in cutaneous testing. The pattern of induration diameter distribution in healthy subjects who took part in the first testing round (64% positively rate) was displaced to the inactivity side (with a peak at 5 to 9-mm diameter), in comparison with the second round (90% positivity rate and peak at 10-14 mm). This indicates a progressive fading of cellular immunity reactions after BCG vaccination. In tuberculosis patients, no correlation was found among the following three parameters: positivity at cutaneous testing (with PPD or A60), titer of anti-A60 mycobacterial immunoglobulins in blood (IgG titer higher than cut-off line) and presence of mycobacteria in sputum.