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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No.: 2008-001489-96 |
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The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | two injections 0.01 µg rdESAT-6 + rCFP-10 (6 weeks interval) |
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| B | Experimental | two injections 0.01 µg rdESAT-6 + rCFP-10 (12 weeks interval) |
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| C | Experimental | two injections 0.1 µg rdESAT-6 + rCFP-10 (6 weeks interval) |
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| D | Experimental | two injections 0.1 µg rdESAT-6 + rCFP-10 (12 weeks interval) |
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| E | Experimental | one injection 1.0 µg rdESAT-6 + rCFP-10 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rdESAT-6 + rCFP-10 | Biological | rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection | onset between the first injection and 28 days after the second injection |
| Measure | Description | Time Frame |
|---|---|---|
| The diameter of induration at the second injection site measured transversely to the long axis of the forearm | 72 hours after the second injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernille Nyholm Tingskov | Statens Serum Institut | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Epidemiklinikken | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20593018 | Derived | Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277. doi: 10.1371/journal.pone.0011277. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |