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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Tuberculosis
Interventions Biological: DAR-901
Biological: Sterile saline placebo
Enrollment 625
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DAR-901 Placebo
Hide Arm/Group Description

0.1 mL intradermal injection of 1 mg DAR-901

DAR-901

0.1 mL intradermal injection of sterile saline for human use

Sterile saline placebo

Period Title: Overall Study
Started 315 310
Completed 281 278
Not Completed 34 32
Reason Not Completed
Lost to Follow-up             34             32
Arm/Group Title DAR-901 Placebo Total
Hide Arm/Group Description

0.1 mL intradermal injection of 1 mg DAR-901

DAR-901

0.1 mL intradermal injection of sterile saline for human use

Sterile saline placebo

Total of all reporting groups
Overall Number of Baseline Participants 315 310 625
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 310 participants 625 participants
<=18 years
315
 100.0%
310
 100.0%
625
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 315 participants 310 participants 625 participants
14.1  (0.76) 14.2  (0.75) 14.15  (.755)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 310 participants 625 participants
Female
192
  61.0%
169
  54.5%
361
  57.8%
Male
123
  39.0%
141
  45.5%
264
  42.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 310 participants 625 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
315
 100.0%
310
 100.0%
625
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Tanzania Number Analyzed 315 participants 310 participants 625 participants
315 310 625
IGRA negative  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 315 participants 310 participants 625 participants
315
 100.0%
310
 100.0%
625
 100.0%
1.Primary Outcome
Title New Infection With Mycobacterium Tuberculosis
Hide Description New infection with TB is based on conversion of IGRA
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Conversion from IGRA neg to pos
Arm/Group Title DAR-901 Placebo
Hide Arm/Group Description:

0.1 mL intradermal injection of 1 mg DAR-901

DAR-901

0.1 mL intradermal injection of sterile saline for human use

Sterile saline placebo

Overall Number of Participants Analyzed 315 310
Measure Type: Count of Participants
Unit of Measure: Participants
19
   6.0%
18
   5.8%
2.Secondary Outcome
Title Persistent New Infection With M. Tuberculosis
Hide Description New positive IGRA that is also positive on repeat ≥3 mos later
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DAR-901 Placebo
Hide Arm/Group Description:

0.1 mL intradermal injection of 1 mg DAR-901

DAR-901

0.1 mL intradermal injection of sterile saline for human use

Sterile saline placebo

Overall Number of Participants Analyzed 315 310
Measure Type: Number
Unit of Measure: participants
10 5
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DAR-901 Placebo
Hide Arm/Group Description

0.1 mL intradermal injection of 1 mg DAR-901

DAR-901

0.1 mL intradermal injection of sterile saline for human use

Sterile saline placebo

All-Cause Mortality
DAR-901 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/315 (0.00%)      0/310 (0.00%)    
Hide Serious Adverse Events
DAR-901 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/315 (1.90%)      3/310 (0.97%)    
Infections and infestations     
Tuberculosis  [1]  3/315 (0.95%)  3 2/310 (0.65%)  2
Tonsillitis   1/315 (0.32%)  1 0/310 (0.00%)  0
Urinary tract infection   1/315 (0.32%)  1 0/310 (0.00%)  0
HIV infection   1/315 (0.32%)  1 0/310 (0.00%)  0
Cellulitis   0/315 (0.00%)  0 1/310 (0.32%)  1
Indicates events were collected by systematic assessment
[1]
Active TB was defined as an SAE for purpose of this study
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DAR-901 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   126/315 (40.00%)      142/310 (45.81%)    
General disorders     
Other   53/315 (16.83%)  53 73/310 (23.55%)  73
Infections and infestations     
Infections and infestations   73/315 (23.17%)  73 69/310 (22.26%)  310
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr C Fordham von Reyn
Organization: Geisel School of Medicine
Phone: 6036505000
EMail: fvr@dartmouth.edu
Layout table for additonal information
Responsible Party: C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02712424    
Other Study ID Numbers: 29001
First Submitted: March 14, 2016
First Posted: March 18, 2016
Results First Submitted: February 10, 2021
Results First Posted: May 11, 2021
Last Update Posted: May 11, 2021