NCT04556981 - Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV | Biotech Hunter

Enrollment

402

Participants

Timeline

Start Date

November 17, 2020

Primary Completion Date

August 12, 2022

Study Completion Date

August 12, 2022

Conditions

Human Immunodeficiency Virus

Interventions

BIOLOGICAL

M72/AS01E Mycobacterium tuberculosis vaccine

Participants will receive an intramuscular dose of M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29

BIOLOGICAL

Placebo

Participants will receive an intramuscular dose of saline (0.9% NaCl), on Day 1 and Day 29

Trial Locations (6)

2001

Wits RHI, Johannesburg

2570

The Aurum Institute, Klerksdorp

4001

CAPRISA, Durban

6850

Desmond Tutu HIV Foundation, Cape Town

SATVI, Worcester

7782

Ekhaya VAC, Cape Town