DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
DAR-PIA
A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study of the Prevention of Infection With Mycobacterium Tuberculosis Among Adolescents Who Have Previously Received BCG
1 other identifier
interventional
625
1 country
1
Brief Summary
DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed with BCG to determine if immunization reduces the risk of TB infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 14, 2016
CompletedFirst Posted
Study publicly available on registry
March 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedResults Posted
Study results publicly available
May 11, 2021
CompletedMay 11, 2021
April 1, 2021
3.9 years
March 14, 2016
February 10, 2021
April 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New Infection With Mycobacterium Tuberculosis
New infection with TB is based on conversion of IGRA
3 years
Secondary Outcomes (1)
Persistent New Infection With M. Tuberculosis
3 years
Study Arms (2)
DAR-901
ACTIVE COMPARATOR0.1 mL intradermal injection of 1 mg DAR-901
Placebo
PLACEBO COMPARATOR0.1 mL intradermal injection of sterile saline for human use
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Related Publications (2)
Munseri P, Said J, Amour M, Magohe A, Matee M, Rees CA, Mackenzie T, Tvaroha S, Bailey-Kellogg C, Maro I, Wieland-Alter W, Adams LV, Horsburgh CR, Nakamura K, Arbeit RD, Pallangyo K, von Reyn CF. DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: A randomized controlled, double-blind phase 2b trial. Vaccine. 2020 Oct 27;38(46):7239-7245. doi: 10.1016/j.vaccine.2020.09.055. Epub 2020 Sep 29.
PMID: 33004239DERIVEDRees CA, Pineros DB, Amour M, Munseri P, Said J, Magohe A, Matee M, Pallangyo K, von Reyn CF. The potential of CBC-derived ratios (monocyte-to-lymphocyte, neutrophil-to-lymphocyte, and platelet-to-lymphocyte) to predict or diagnose incident TB infection in Tanzanian adolescents. BMC Infect Dis. 2020 Aug 18;20(1):609. doi: 10.1186/s12879-020-05331-w.
PMID: 32811463DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr C Fordham von Reyn
- Organization
- Geisel School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
C Fordham von Reyn, MD
Dartmouth-Hitchcock Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
March 14, 2016
First Posted
March 18, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
May 11, 2021
Results First Posted
May 11, 2021
Record last verified: 2021-04