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

NCT04556981 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2025-07-17

Study results available
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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

  • 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

Sponsors & Collaborators

  • Wellcome Trust

    collaborator OTHER

  • Gates Medical Research Institute

    lead OTHER

Principal Investigators

  • Gates MRI · Gates Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-17
Primary Completion
2022-08-12
Completion
2022-08-12

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556981 on ClinicalTrials.gov