DAR-901 TB Booster Vaccine to Prevent TB in Adolescents (DAR-PIA)
|Tuberculosis||Biological: DAR-901 Biological: Sterile saline placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study of the Prevention of Infection With Mycobacterium Tuberculosis Among Adolescents Who Have Previously Received BCG|
- New infection with Mycobacterium tuberculosis [ Time Frame: 2 years ]Based on conversion of IGRA
- Persistent new infection with M. tuberculosis [ Time Frame: 2 years ]New positive IGRA that is also positive on repeat ≥3 mos later
|Study Start Date:||March 2016|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
Active Comparator: DAR-901
0.1 mL intradermal injection of 1 mg DAR-901
Placebo Comparator: Placebo
0.1 mL intradermal injection of sterile saline for human use
|Biological: Sterile saline placebo|
DAR-901 whole cell booster vaccine to prevent TB infection in adolescents ("DAR-PIA")
This is a Phase II, 3-injection, randomized, controlled trial of DAR-901 to be conducted in 13-15 year old adolescents in Tanzania previously immunized with BCG. DAR-901 is a whole cell inactivated non-tuberculous mycobacterial vaccine manufactured from the Master Cell Bank of SRL-172 that was used in the successful Phase III DarDar Trial in Tanzania. The goals are to establish the safety and efficacy of DAR-901 in preventing infection with TB. The 1 mg dose was selected during the current Phase I dose-escalation trial of DAR-901 in the US being conducted by Dartmouth and Aeras. The 1 mg dose corresponds to the dose of SRL 172 used in the DarDar Trial.
All subjects will be screened by the T-spot® IGRA (Oxford Immunotec, Oxford, England) for evidence of TB infection. All screened subjects will have a structured interview to identify risk factors for TB infection (=positive IGRA). IGRA-positive subjects will be referred for further evaluation and will not be entered in the immunization phase of the trial.
It is estimated that 1000 adolescents will need to be screened to identify a total of 650 IGRA-negative adolescents in the immunization phase of the trial. Subjects will be and randomized 1:1 to DAR-901 or saline control at 0, 2 and 4 months. Doses will be administered by intradermal (ID) injection in the deltoid area. IGRA testing will be repeated before dose 2, at 14 months, and again at 24 months.
The two year study is scheduled to begin in the first quarter of 2016 in Dar es Salaam, is funded by GHIT-Japan and will be directed by Geisel School of Medicine at Dartmouth (PI, F. von Reyn) with collaborators at Muhimbili University of Health and Allied Sciences (MUHAS) in Tanzania and Tokyo Medical and Dental University in Japan.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02712424
|Muhimbili University of Health and Allied Sciences|
|Dar es Salaam, Tanzania|
|Principal Investigator:||C Fordham von Reyn, MD||Dartmouth-Hitchcock Medical Center|