Trial Outcomes & Findings for DAR-901 TB Booster Vaccine to Prevent TB in Adolescents (NCT NCT02712424)

NCT ID: NCT02712424

Last Updated: 2021-05-11

Results Overview

New infection with TB is based on conversion of IGRA

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 625 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2021-05-11

Participant Flow

Participant milestones

Measure	DAR-901 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo
Overall Study STARTED	315	310
Overall Study COMPLETED	281	278
Overall Study NOT COMPLETED	34	32

Reasons for withdrawal

Measure	DAR-901 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo
Overall Study Lost to Follow-up	34	32

Baseline Characteristics

DAR-901 TB Booster Vaccine to Prevent TB in Adolescents

Baseline characteristics by cohort

Measure	DAR-901 n=315 Participants 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo n=310 Participants 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo	Total n=625 Participants Total of all reporting groups
Age, Categorical <=18 years	315 Participants n=5 Participants	310 Participants n=7 Participants	625 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	14.1 years STANDARD_DEVIATION 0.76 • n=5 Participants	14.2 years STANDARD_DEVIATION 0.75 • n=7 Participants	14.15 years STANDARD_DEVIATION .755 • n=5 Participants
Sex: Female, Male Female	192 Participants n=5 Participants	169 Participants n=7 Participants	361 Participants n=5 Participants
Sex: Female, Male Male	123 Participants n=5 Participants	141 Participants n=7 Participants	264 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	315 Participants n=5 Participants	310 Participants n=7 Participants	625 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Tanzania	315 participants n=5 Participants	310 participants n=7 Participants	625 participants n=5 Participants
IGRA negative	315 Participants n=5 Participants	310 Participants n=7 Participants	625 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Conversion from IGRA neg to pos

New infection with TB is based on conversion of IGRA

Outcome measures

Measure	DAR-901 n=315 Participants 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo n=310 Participants 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo
New Infection With Mycobacterium Tuberculosis	19 Participants	18 Participants

SECONDARY outcome

Timeframe: 3 years

New positive IGRA that is also positive on repeat ≥3 mos later

Outcome measures

Measure	DAR-901 n=315 Participants 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo n=310 Participants 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo
Persistent New Infection With M. Tuberculosis	10 participants	5 participants

Adverse Events

DAR-901

Serious events: 6 serious events

Other events: 126 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 142 other events

Deaths: 0 deaths

Serious adverse events

Measure	DAR-901 n=315 participants at risk 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo n=310 participants at risk 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo
Infections and infestations Tuberculosis	0.95% 3/315 • Number of events 3 • 3 years	0.65% 2/310 • Number of events 2 • 3 years
Infections and infestations Tonsillitis	0.32% 1/315 • Number of events 1 • 3 years	0.00% 0/310 • 3 years
Infections and infestations Urinary tract infection	0.32% 1/315 • Number of events 1 • 3 years	0.00% 0/310 • 3 years
Infections and infestations HIV infection	0.32% 1/315 • Number of events 1 • 3 years	0.00% 0/310 • 3 years
Infections and infestations Cellulitis	0.00% 0/315 • 3 years	0.32% 1/310 • Number of events 1 • 3 years

Other adverse events

Measure	DAR-901 n=315 participants at risk 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901	Placebo n=310 participants at risk 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo
Infections and infestations Infections and infestations	23.2% 73/315 • Number of events 73 • 3 years	22.3% 69/310 • Number of events 310 • 3 years
General disorders Other	16.8% 53/315 • Number of events 53 • 3 years	23.5% 73/310 • Number of events 73 • 3 years

Additional Information

Dr C Fordham von Reyn

Geisel School of Medicine

Phone: 6036505000

Email: fvr@dartmouth.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place