Phase 2 N=625 Randomized Quadruple-blind Prevention

DAR-901 TB Booster Vaccine to Prevent TB in Adolescents

Tuberculosis

Bottom Line

View on ClinicalTrials.gov: NCT02712424 ↗

Enrolled (actual)

625

Serious AEs

1.4%

Results posted

May 2021

Primary outcome: Primary: New Infection With Mycobacterium Tuberculosis — 19; 18 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: DAR-901 (Biological); Sterile saline placebo (Biological)
Age: Pediatric · 13+ yrs
Sex: All
Sponsor: Dartmouth-Hitchcock Medical Center
Primary completion: Feb 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY New Infection With Mycobacterium Tuberculosis	19; 18	—
SECONDARY Persistent New Infection With M. Tuberculosis	10; 5	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02712424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.