Table 1.
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.