DAR-901 TB Booster Vaccine to Prevent TB in Adolescents

Tuberculosis Clinical Trial

— DAR-PIA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712424
• Other study ID #: 29001
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: February 1, 2020

Study information

• Verified date: April 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 625
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

Inclusion Criteria: Negative IGRA at baseline - Exclusion Criteria: Pregnancy, serious underlying disease -

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• DAR-901

• Sterile saline placebo

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Infection With Mycobacterium Tuberculosis	New infection with TB is based on conversion of IGRA	3 years
Secondary	Persistent New Infection With M. Tuberculosis	New positive IGRA that is also positive on repeat =3 mos later	3 years