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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02712424
Recruitment Status : Completed
First Posted : March 18, 2016
Results First Posted : May 11, 2021
Last Update Posted : May 11, 2021
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by (Responsible Party):
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 18, 2016
Results First Submitted Date  ICMJE February 10, 2021
Results First Posted Date  ICMJE May 11, 2021
Last Update Posted Date May 11, 2021
Study Start Date  ICMJE March 2016
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2021)
New Infection With Mycobacterium Tuberculosis [ Time Frame: 3 years ]
New infection with TB is based on conversion of IGRA
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
New infection with Mycobacterium tuberculosis [ Time Frame: 2 years ]
Based on conversion of IGRA
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2021)
Persistent New Infection With M. Tuberculosis [ Time Frame: 3 years ]
New positive IGRA that is also positive on repeat ≥3 mos later
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2016)
Persistent new infection with M. tuberculosis [ Time Frame: 2 years ]
New positive IGRA that is also positive on repeat ≥3 mos later
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
Official Title  ICMJE A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Study of the Prevention of Infection With Mycobacterium Tuberculosis Among Adolescents Who Have Previously Received BCG
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
Detailed Description

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.

This three year study began 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.

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: Prevention
Condition  ICMJE Tuberculosis
Intervention  ICMJE
  • Biological: DAR-901
  • Biological: Sterile saline placebo
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2021)
625
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2016)
650
Actual Study Completion Date  ICMJE February 1, 2020
Actual Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Negative IGRA at baseline -

Exclusion Criteria: Pregnancy, serious underlying disease

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tanzania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02712424
Other Study ID Numbers  ICMJE 29001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
Original Responsible Party Dartmouth-Hitchcock Medical Center
Current Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Muhimbili University of Health and Allied Sciences
Investigators  ICMJE
Principal Investigator: C Fordham von Reyn, MD Dartmouth-Hitchcock Medical Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date April 2021

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