Safety and efficacy of tuberculosis vaccine candidates in low- and middle-income countries: a systematic review of randomised controlled clinical trials

Table 1 Efficacy results from included papers

Efficacy Outcomes	Intervention n (%)	Control n (%)	Efficacy rate (95% confidence intervals)
Tait, 2019^a, M72/AS01_E	n = 1783	n = 1783
Bacteriologically confirmed TB, sputum obtained prior to treatment initiation^b	13 (1)	28 (2)	54.1 (11.5, 76.2)
PCR-positive TB, sputum obtained prior to treatment initiation^b	8 (< 1)	22 (1)	64.1 (19.3, 84.0)
Bacteriologically confirmed and/or PCR-positive TB, sputum obtained up to 4 weeks after treatment initiation^b	20 (1)	32 (2)	38.2 (− 8.0, 64.7)
Bacteriologically confirmed and/or PCR-positive TB, sputum obtained up to 4 weeks after treatment initiation	20 (1)	34 (2)	41.9 (− 1.0, 66.5)
Clinical TB	28 (2)	38 (2)	26.5 (− 19.8, 54.9)
Clinical TB^b	27 (2)	36 (2)	25.2 (− 23.3, 54.6)
Sensitivity analysis: Two bacteriologically confirmed TB tests prior to treatment^b	7 (< 1)	22 (1)	68.0 (25.1, 86.3)
Munseri, 2020, DAR-901	n = 314	n = 310
New TB infection^c	19 (6)	18 (6)	3.2 (− 13.9, 17.7)
Persistent TB infection^d	10 (3)	5 (1)	4.4 (− 12.1, 18.5)

^aResults from total efficacy cohort (intention to treat analysis) are presented. Per protocol analysis results were similar
^bHIV-positive participants were excluded
^cNew TB infection was defined as conversion from IGRA-negative at baseline and at two months to IGRA-positive at any subsequent visit
^dPersistent TB infection was defined as participants with new TB infection plus a subsequent positive IGRA at three months or later

ISSN: 1471-2334