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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number: TEST-001599-14 |
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The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antigen group + high adjuvans | Experimental | The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart. |
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| Antigen group | Experimental | The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart. |
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| Antigen + low adjuvans group | Experimental | The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 microgram antigen (Ag85B + ESAT-6) | Biological | 0.5 mL suspension for injection x 2 with 2 months interval |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests. | From the first vaccination until 8 months after the first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA. | From first vaccination until 36 months after first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaap van Dissel, MD, Prof. | Leiden University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Centre | Leiden | RC Leiden | 2300 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21178394 | Derived | Ottenhoff TH, Doherty TM, van Dissel JT, Bang P, Lingnau K, Kromann I, Andersen P. First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses. Hum Vaccin. 2010 Dec;6(12):1007-15. doi: 10.4161/hv.6.12.13143. Epub 2010 Dec 1. | |
| 20226890 |
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| 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a | Biological | 0.5 mL suspension for injection x 2 with 2 months interval |
|
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| 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a | Biological | 0.5 mL suspension for injection x 2 with 2 months interval |
|
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| van Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, Lingnau K, Nouta J, Klein MR, Rosenkrands I, Ottenhoff TH, Kromann I, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine. 2010 Apr 30;28(20):3571-81. doi: 10.1016/j.vaccine.2010.02.094. Epub 2010 Mar 11. |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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