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| Name | Class |
|---|---|
| Muhimbili University of Health and Allied Sciences | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAR-901 | Active Comparator | 0.1 mL intradermal injection of 1 mg DAR-901 |
|
| Placebo | Placebo Comparator | 0.1 mL intradermal injection of sterile saline for human use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAR-901 | Biological |
| ||
| Sterile saline placebo |
| Measure | Description | Time Frame |
|---|---|---|
| New Infection With Mycobacterium Tuberculosis | New infection with TB is based on conversion of IGRA | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent New Infection With M. Tuberculosis | New positive IGRA that is also positive on repeat ≥3 mos later | 3 years |
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Inclusion Criteria: Negative IGRA at baseline -
Exclusion Criteria: Pregnancy, serious underlying disease
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| Name | Affiliation | Role |
|---|---|---|
| C Fordham von Reyn, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muhimbili University of Health and Allied Sciences | Dar es Salaam | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33004239 | Derived | Munseri P, Said J, Amour M, Magohe A, Matee M, Rees CA, Mackenzie T, Tvaroha S, Bailey-Kellogg C, Maro I, Wieland-Alter W, Adams LV, Horsburgh CR, Nakamura K, Arbeit RD, Pallangyo K, von Reyn CF. DAR-901 vaccine for the prevention of infection with Mycobacterium tuberculosis among BCG-immunized adolescents in Tanzania: A randomized controlled, double-blind phase 2b trial. Vaccine. 2020 Oct 27;38(46):7239-7245. doi: 10.1016/j.vaccine.2020.09.055. Epub 2020 Sep 29. | |
| 32811463 |
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| ID | Title | Description |
|---|---|---|
| FG000 | DAR-901 | 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901 |
| FG001 | Placebo | 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DAR-901 | 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901 |
| BG001 | Placebo | 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | New Infection With Mycobacterium Tuberculosis | New infection with TB is based on conversion of IGRA | Conversion from IGRA neg to pos | Posted | Count of Participants | Participants | 3 years |
|
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DAR-901 | 0.1 mL intradermal injection of 1 mg DAR-901 DAR-901 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tuberculosis | Infections and infestations | Systematic Assessment | Active TB was defined as an SAE for purpose of this study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr C Fordham von Reyn | Geisel School of Medicine | 6036505000 | fvr@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 1, 2018 | Feb 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 25, 2019 | Feb 9, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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|
| Derived |
| Rees CA, Pineros DB, Amour M, Munseri P, Said J, Magohe A, Matee M, Pallangyo K, von Reyn CF. The potential of CBC-derived ratios (monocyte-to-lymphocyte, neutrophil-to-lymphocyte, and platelet-to-lymphocyte) to predict or diagnose incident TB infection in Tanzanian adolescents. BMC Infect Dis. 2020 Aug 18;20(1):609. doi: 10.1186/s12879-020-05331-w. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| IGRA negative | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Persistent New Infection With M. Tuberculosis | New positive IGRA that is also positive on repeat ≥3 mos later | Posted | Number | participants | 3 years |
|
|
|
| 315 |
| 6 |
| 315 |
| 126 |
| 315 |
| EG001 | Placebo | 0.1 mL intradermal injection of sterile saline for human use Sterile saline placebo | 0 | 310 | 3 | 310 | 142 | 310 |
|
| Tonsillitis | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| HIV infection | Infections and infestations | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Other | General disorders | Systematic Assessment |
|
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |