At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 402 enrolled
Drug / intervention
M72/AS01E Mycobacterium tuberculosis vaccine +1 morebiological
Likely dose
M72/AS01E Mycobacterium tuberculosis vaccine 10 microgramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating M72/AS01E Mycobacterium tuberculosis vaccine and Placebo for Human Immunodeficiency Virus. Completed, enrolled 402 participants across 6 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesSouth Africa
CollaboratorsWellcome Trust
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedSep 2020
Enrollment StartNov 2020
Primary CompletionAug 2022
TodayJul 2026
First PostedSep 21, 2020
Enrollment StartNov 17, 2020
Primary CompletionAug 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.8 years ago
Interventions
M72/AS01E Mycobacterium tuberculosis vaccinebiological
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
Placebobiological
Participants will receive an intramuscular dose of saline (0.9% NaCl), on Day 1 and Day 29