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. 2019 Sep 3;10:2089. doi: 10.3389/fimmu.2019.02089

Table 1.

Characteristics of the studies included in the review.

References Design Country Population Age Male/Female Followed-up Groups(N)
Montoya et al. (11) Phase II RCT Philippines PPD-positive 3–10 mm; 18–45 years 38/142 6 months M72/AS01B(N = 40)
M72/AS01E(N = 40)
M72/AS01E(N = 40)
M72/AS02D(N = 40)
M72/Saline(N = 10) AS01B alone(N = 10)
Thacher et al. (13) Phase I/II RCT Switzerland HIV+ on cART; 18–50 years 26/11 6 months M72/AS01E(N = 22)
AS01 alone(N = 8)
Saline(N = 7)
Idoko et al. (14) Phase II RCT Gambia BCG-vaccinated infants; 2–7 months 159/141 6 months Dose-outside EPI
1 dose M72/AS01E (N = 50)
2 doses M72/AS01E (N = 50) control(N = 50)
Dose-within EPI
1 dose M72/AS01E (N = 52)
2 dosesM72/AS01E (N = 49)
EPI only (N = 49)
Penn-Nicholson et al. (12) Phase II RCT South Africa HIV-negative adolescents; 13–17 years 31/29 6 months M72/AS01E(N = 80)
Saline(N = 38)
Kumarasamy et al. (15) Phase II RCT India QFT negative or positive; 18–59 years 167/73 12 months ART-stable
M72/AS01E (N = 40)
Saline(N = 40)
ART-naive
M72/AS01E (N = 40)
Saline(N = 40)
HIV-ve M72/AS01E (N = 40)
Saline(N = 40)
Gillard et al. (16) Phase II RCT Taiwan Estonia Confirmed pulmonary TB; Treated pulmonary TB; No active pulmonary disease; 18–59 years 82/60 6 months M72/AS01E (N = 71)
Saline (N = 71)
Meeren et al. (17) Phase IIb RCT Kenya South Africa Zambia Healthy; Stable chronic medical conditions; 18–50 years 2044/1529 3 years M72/AS01E (N = 1786)
Saline (N = 1787)

RCT, randomized controlled trial; PPD, tuberculin purified protein derivative; BCG, Bacillus Calmette–Guerin; HIV, human immunodeficiency virus; TB, tuberculosis; cART, combination anti-retroviral therapy; QTF, QuantiFERON Gold In-Tube test.