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| ID | Type | Description | Link |
|---|---|---|---|
| CCTB001-01 |
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| Name | Class |
|---|---|
| Corixa Corporation | INDUSTRY |
This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Subjects receiving the low-dose antigen candidate TB vaccine |
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| Group B | Experimental | Subjects receiving the high-dose antigen candidate TB vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK's candidate Mycobacterium tuberculosis vaccine 692342 | Biological | Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of dose limiting toxicity | From study start up to Day 56. | |
| Occurrence of serious adverse events | During the entire study period. | |
| Occurrence of adverse events | At each visit | |
| Laboratory measurements of serum chemistry and hematology | At study start, prior to each vaccination and 1 and 6 months after dose 3 | |
| Resting vital signs (blood pressure, pulse, temperature) | At study start, prior to each vaccination and 1 and 6 months after dose 3 | |
| Chest X-ray findings | At study start and study end |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains. | Prior to each vaccination and 1 and 6 months after dose 3 | |
| Evaluation of PPD skin reactivity | At study start and study end |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Clinical Trials Call Center | Tacoma | Washington | 9843 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19587528 | Derived | Von Eschen K, Morrison R, Braun M, Ofori-Anyinam O, De Kock E, Pavithran P, Koutsoukos M, Moris P, Cain D, Dubois MC, Cohen J, Ballou WR. The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans. Hum Vaccin. 2009 Jul;5(7):475-82. doi: 10.4161/hv.8570. Epub 2009 Jul 27. |
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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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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |