Fig 1.
Overview of the trial participants.
*These were clinic attendees that on follow-up segregated into those with microbiologically confirmed active TB and non-TB participants. Efficacy data are presented as number of test positives/n (%).
Table 1.
Demographics of the trial population.
Table 2.
Sensitivity of C-Tb versus TST (top) and QFT (bottom) in microbiologically confirmed active TB cases.
Table 3.
Test positive results of C-Tb versus TST (top) and QFT (bottom) in non-TB participants.
Fig 2.
Test positivity rate according to HIV status and CD4 count.
The data shown excludes participants with unknown HIV status and healthy control group. Error bars indicate 95% CI. Cut-point for TST was 5 mm in HIV-infected and 15 mm in others. C-Tb: N = 921 (625 HIV-uninfected, 296 HIV-infected). TST: N = 923 (627 HIV-uninfected, 296 HIV-infected). QFT: N = 818 (126 indeterminate, 538 HIV-uninfected, 280 HIV-infected). Data specific to the active and non-TB groups are shown in S2–S4 Tables. *HIV-uninfected versus HIV-infected p<0.05. †CD4 counts ≥100 cells/μL versus counts <100 cells/μL in HIV-infected; p<0.05.
Table 4.
Test positive results of C-Tb versus TST in children <5 years.
Fig 3.
Test positivity rates in different subgroups of children comparing TST and C-Tb along an exposure gradient.
Healthy control group (5–11 years, n = 100), asymptomatic PTB contacts <5 years (n = 87) and active TB cases <18 years (n = 15, no HIV-infected). Error bars indicate 95% CI.
Table 5.
Injection site reactions in the full analysis set.