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| Name | Class |
|---|---|
| Aeras | OTHER |
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This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAR-901 | Experimental | Intradermal administration at 0, 2 and 4 months Three dose groups in dose escalation: 0.1 mg, 0.3 mg and 1.0 mg, all constituted in 0.1 mL |
|
| BCG | Active Comparator | Intradermal injection of 0.1 mL saline at 0 mos, 2 mos, intradermal injection of 0.1 mL BCG at 4 mos |
|
| Sterile saline | Placebo Comparator | Intradermal injection of 0.1 mL sterile saline at 0, 2 and 4 mos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAR-901 | Biological |
| ||
| BCG |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Subjects will be followed for both systemic side effects and injection site reactions | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Cellular and humoral responses to the vaccine antigen will be tested at baseline and after each of 3 doses of vaccine | 10 months |
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Inclusion Criteria:
All subjects: age 18-65, prior BCG vaccine (scar)
56 HIV negative subjects: negative ELISA for HIV (48 subjects with negative IGRA, 8 subjects with positive IGRA)
21 HIV positive subjects: positive ELISA for HIV, on ART (13 subjects with negative IGRA, 8 subjects with positive IGRA)
Exclusion Criteria: pregnancy, positive serology for hepatitis B or C, active tuberculosis immunosuppression, severe medical illness
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| Name | Affiliation | Role |
|---|---|---|
| Charles F. von Reyn, MD | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31120957 | Derived | Masonou T, Hokey DA, Lahey T, Halliday A, Berrocal-Almanza LC, Wieland-Alter WF, Arbeit RD, Lalvani A, von Reyn CF. CD4+ T cell cytokine responses to the DAR-901 booster vaccine in BCG-primed adults: A randomized, placebo-controlled trial. PLoS One. 2019 May 23;14(5):e0217091. doi: 10.1371/journal.pone.0217091. eCollection 2019. | |
| 29685114 |
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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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|
| Sterile saline | Biological |
|
| Craig SR, Lahey T, Dixit A, Fordham von Reyn C. Altruism, Scepticism, and collective decision-making in foreign-born U.S. residents in a tuberculosis vaccine trial. BMC Public Health. 2018 Apr 23;18(1):535. doi: 10.1186/s12889-018-5460-3. |
| 28498853 | Derived | von Reyn CF, Lahey T, Arbeit RD, Landry B, Kailani L, Adams LV, Haynes BC, Mackenzie T, Wieland-Alter W, Connor RI, Tvaroha S, Hokey DA, Ginsberg AM, Waddell R. Safety and immunogenicity of an inactivated whole cell tuberculosis vaccine booster in adults primed with BCG: A randomized, controlled trial of DAR-901. PLoS One. 2017 May 12;12(5):e0175215. doi: 10.1371/journal.pone.0175215. eCollection 2017. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |