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This study will assess the safety and immunogenicity of a GSK Biologicals' candidate TB vaccine administered at 0, 1 months to healthy adults living in a TB-endemic region. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | These subjects were further stratified into 3 groups according to the size of their PPD skin test reactions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' Candidate Tuberculosis (TB) Vaccine (692342) | Biological | Intramuscular injection, 2 doses at 0, 1 month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence, intensity and relationship to vaccination of solicited local and general symptoms | During the 7-day follow-up period following vaccination after each vaccine dose | |
| Occurrence, intensity and relationship to vaccination of unsolicited symptoms | During the 30-day follow-up period following vaccination after each vaccine dose | |
| Occurrence and relationship to vaccination of serious adverse events | During the entire study period | |
| Haematological and biochemical levels | At protocol defined time points |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of cytokine expression by M72-specific CD4+/CD8+ T cells by means of invitro flow cytometry | At protocol defined time points | |
| Antibody titres to M72 measured by ELISA | At protocol defined time points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Worcester | Western Province | 6850 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23306546 | Background | Day CL, Tameris M, Mansoor N, van Rooyen M, de Kock M, Geldenhuys H, Erasmus M, Makhethe L, Hughes EJ, Gelderbloem S, Bollaerts A, Bourguignon P, Cohen J, Demoitie MA, Mettens P, Moris P, Sadoff JC, Hawkridge A, Hussey GD, Mahomed H, Ofori-Anyinam O, Hanekom WA. Induction and regulation of T-cell immunity by the novel tuberculosis vaccine M72/AS01 in South African adults. Am J Respir Crit Care Med. 2013 Aug 15;188(4):492-502. doi: 10.1164/rccm.201208-1385OC. |
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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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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |