Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV (MESA-TB)
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ClinicalTrials.gov Identifier: NCT04556981 |
Recruitment Status :
Completed
First Posted : September 21, 2020
Last Update Posted : June 13, 2023
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Sponsor:
Bill & Melinda Gates Medical Research Institute
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Bill & Melinda Gates Medical Research Institute
Tracking Information | |||||||
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First Submitted Date ICMJE | September 10, 2020 | ||||||
First Posted Date ICMJE | September 21, 2020 | ||||||
Last Update Posted Date | June 13, 2023 | ||||||
Actual Study Start Date ICMJE | November 17, 2020 | ||||||
Actual Primary Completion Date | August 12, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine M72/AS01E in Participants With Well-controlled HIV | ||||||
Official Title ICMJE | 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) | ||||||
Brief 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). | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Human Immunodeficiency Virus | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
402 | ||||||
Original Estimated Enrollment ICMJE |
400 | ||||||
Actual Study Completion Date ICMJE | August 12, 2022 | ||||||
Actual Primary Completion Date | August 12, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 16 Years to 35 Years (Child, Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | South Africa | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04556981 | ||||||
Other Study ID Numbers ICMJE | Gates MRI-TBV02-202 221698/Z/20/Z ( Other Grant/Funding Number: Wellcome Trust ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Bill & Melinda Gates Medical Research Institute | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Bill & Melinda Gates Medical Research Institute | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Wellcome Trust | ||||||
Investigators ICMJE |
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PRS Account | Bill & Melinda Gates Medical Research Institute | ||||||
Verification Date | June 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |