Figure 1.
CONSORT flow diagram, Phase II, Stage C-1 Trial.
Figure 2.
Phase II, Stage A/B – DTH induration by subject.
Phase II, Stage A/B graph depicting DTH indurations elicited by leprosy skin test antigens at the high dose (1.0 µg) and low dose (0.1 µg), and PPD at 5 TU: A) MLCwA, and B) MLSA-LAM. The first five subjects on both graphs represent subjects from Stage A, and the remaining 45 subjects on both graphs represent subjects from Stage B.
Table 1.
Phase II, Stage A/B: Frequency of induration size (EC relative to PPD).
Figure 3.
Dot plot of induration measurements.
Induration results are provided across five subject groups, including BL/LL leprosy patients (n = 19 in low and n = 20 in high dose group), BT/TT leprosy patients (n = 20), HC (n = 20), TB (n = 20), and ECs (n = 50). Low and high dose groups were combined to show PPD responses: BL/LL leprosy patients (n = 39) and all other groups (n = 40). Mean and standard deviation are shown.
Figure 4.
Distribution frequency of induration.
Frequency distribution graphs were used to establish cut off points for each skin test antigen at each dosage tested: A) MLSA-LAM low dose, B) MLCwA low dose, C) MLSA-LAM high dose, D) MLCwA high dose. Frequency of induration reaction (mm) of EC and TB groups were graphed against BT/TT and BL/LL leprosy groups. The anti-mode between the control and leprosy patient group represents the cut off for each antigen and antigen dose.
Table 2.
Number of positive responders and mean induration compared to ECs.
Table 3.
Diagnostic test statistics – Skin test.
Table 4.
Diagnostic test statistics – WB-IGRAa.