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DAR-901 TB Booster Vaccine to Prevent TB in Adolescents (DAR-PIA)

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ClinicalTrials.gov Identifier: NCT02712424
Recruitment Status : Active, not recruiting
First Posted : March 18, 2016
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center

March 14, 2016
March 18, 2016
March 30, 2018
March 2016
November 2019   (Final data collection date for primary outcome measure)
New infection with Mycobacterium tuberculosis [ Time Frame: 2 years ]
Based on conversion of IGRA
Same as current
Complete list of historical versions of study NCT02712424 on ClinicalTrials.gov Archive Site
Persistent new infection with M. tuberculosis [ Time Frame: 2 years ]
New positive IGRA that is also positive on repeat ≥3 mos later
Same as current
Not Provided
Not Provided
 
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study of the Prevention of Infection With Mycobacterium Tuberculosis Among Adolescents Who Have Previously Received BCG
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

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Tuberculosis
  • Biological: DAR-901
  • Biological: Sterile saline placebo
  • Active Comparator: DAR-901
    0.1 mL intradermal injection of 1 mg DAR-901
    Intervention: Biological: DAR-901
  • Placebo Comparator: Placebo
    0.1 mL intradermal injection of sterile saline for human use
    Intervention: Biological: Sterile saline placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
650
Same as current
December 2019
November 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria: Negative IGRA at baseline -

Exclusion Criteria: Pregnancy, serious underlying disease

Sexes Eligible for Study: All
13 Years to 15 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
 
NCT02712424
29001
Yes
Not Provided
Not Provided
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Muhimbili University of Health and Allied Sciences
Principal Investigator: C Fordham von Reyn, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP