DAR-901 TB Booster Vaccine to Prevent TB in Adolescents

Phase 2

Completed

• Conditions: Tuberculosis
• Interventions: Biological: DAR-901; Biological: Sterile saline placebo

• Registration Number: NCT02712424
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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 Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-18
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Results First Submitted: 2021-02-10
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-17
• Last Update Submitted: 2021-04-17
• Results First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 625

Inclusion Criteria

Negative IGRA at baseline -

Exclusion Criteria

Pregnancy, serious underlying disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAR-901	DAR-901	0.1 mL intradermal injection of 1 mg DAR-901
Placebo	Sterile saline placebo	0.1 mL intradermal injection of sterile saline for human use

Primary Outcome Measures

Name	Time	Method
New Infection With Mycobacterium Tuberculosis	3 years	New infection with TB is based on conversion of IGRA

Secondary Outcome Measures

Name	Time	Method
Persistent New Infection With M. Tuberculosis	3 years	New positive IGRA that is also positive on repeat ≥3 mos later

Trial Locations

Locations (1)

Muhimbili University of Health and Allied Sciences; 🇹🇿 Dar es Salaam, Tanzania