Trials / Completed
CompletedNCT04556981
Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV
A Randomized, Placebo-controlled, Observer-blind, Phase 2 Study to Evaluate Safety and Immunogenicity of the Investigational M72/AS01E Mycobacterium Tuberculosis (Mtb) Vaccine in Virally Suppressed, Antiretroviral-treated Participants With Human Immunodeficiency Virus (HIV)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 402 (actual)
- Sponsor
- Gates Medical Research Institute · Academic / Other
- Sex
- All
- Age
- 16 Years – 35 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and immunogenicity of M72/AS01E vaccination in virally suppressed, antiretroviral-treated participants with human immunodeficiency virus infection (HIV).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2020-11-17
- Primary completion
- 2022-08-12
- Completion
- 2022-08-12
- First posted
- 2020-09-21
- Last updated
- 2025-07-17
- Results posted
- 2025-07-17
Locations
6 sites across 1 country: South Africa
Source: ClinicalTrials.gov record NCT04556981. Inclusion in this directory is not an endorsement.