NCT06062238 - Study to Assess Efficacy and Safety of M72/AS01E-4 Mycobacterium Tuberculosis (Mtb) Vaccine in Adolescents and Adults | Biotech Hunter

Enrollment

20,081

Participants

Timeline

Start Date

March 5, 2024

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions

Tuberculosis

Interventions

BIOLOGICAL

M72/AS01E-4 Mycobacterium tuberculosis investigational vaccine

Participants will receive an intramuscular dose of M72 (recombinant fusion protein) reconstituted with AS01E-4 (an adjuvant system), on Day 1 and Day 29.

BIOLOGICAL

Placebo

Participants will receive an intramuscular dose of normal saline (0.9 percent \[%\] sodium chloride \[NaCl\]), on Day 1 and Day 29.

Trial Locations (54)

412

1303-Gates MRI Investigational Site, Lusaka

1050

1004-Gates MRI Investigational Site, Middelburg

1401

1028-Gates MRI Investigational Site, Johannesburg

1632

1025-Gates MRI Investigational Site, Tembisa

1032-Gates MRI Investigational Site #1, Tembisa

1811

1031-Gates MRI Investigational Site, Johannesburg

1818

1011-Gates MRI Investigational Site, Soweto

1864

1018-Gates MRI Investigational Site, Johannesburg

1935

1030-Gates MRI Investigational Site, Vereeniging

2001

1020-Gates MRI Investigational Site, Johannesburg

2013

1015-Gates MRI Investigational Site, Soweto

2193

1007-Gates MRI Investigational Site, Johannesburg

2570

1017-Gates MRI Investigational Site, Klerksdorp

2574

1014-Gates MRI Investigational Site, Jouberton

3370

1012-Gates MRI Investigational Site, Ladysmith

3610

1009-Gates MRI Investigational Site, Durban

3935

1002-Gates MRI Investigational Site, Mtubatuba

4068

1026-Gates MRI Investigational Site, Durban

4091

1029-Gates MRI Investigational Site, Durban

5201

1010-Gates MRI Investigational Site, East London

6001

1013-Gates MRI Investigational Site, Port Elizabeth

6850

1023-Gates MRI Investigational Site, Worcester

7405

1021-Gates MRI Investigational Site, Cape Town

7505

1024-Gates MRI Investigational Site, Cape Town

7530

1006-Gates MRI Investigational Site, Cape Town

7626

1001-Gates MRI Investigational Site, Paarl

7700

1003-Gates MRI Investigational Site, Cape Town

7750

1034-Gates MRI Investigational Site, Cape Town

7784

1022-Gates MRI Investigational Site, Cape Town

7925

1008-Gates MRI Investigational Site, Cape Town

8301

1027-Gates MRI Investigational Site, Kimberley

9301

1033-Gates MRI Investigational Site, Bloemfontein

10101

1302-Gates MRI Investigational Site, Lusaka

10430

2202-Gates MRI Investigational Site, Jakarta

10510

2205-Gates MRI Investigational Site, Jakarta

13230

2203-Gates MRI Investigational Site, Jakarta

16424

2204-Gates MRI Investigational Site, Depok

20200

1206-Gates MRI Investigational Site, Kericho

30096

2402-Gates MRI Investigational Site, Chichiri

30100

1205-Gates MRI Investigational Site, Eldoret

40100

1202-Gates MRI Investigational Site, Kisumu

40161

2201-Gates MRI Investigational Site, Bandung

40300

1203-Gates MRI Investigational Site, Homa Bay

50697

1301-Gates MRI Investigational Site, Lusaka

80103

1204-Gates MRI Investigational Site, Mombasa

80108

1207-Gates MRI Investigational Site, Kilifi

90100

1208-Gates MRI Investigational Site, Machakos

240262

1304-Gates MRI Investigational Site, Ndola

00100

1209-Gates MRI Investigational Site, Nairobi

00202

1201-Gates MRI Investigational Site, Nairobi

0149

2401-Gates MRI Investigational Site, Lilongwe

0250

1016-Gates MRI Investigational Site, Brits

0152

1005-Gates MRI Investigational Site, Pretoria

0299

1019-Gates MRI Investigational Site, Rustenburg