Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
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|ClinicalTrials.gov Identifier: NCT02097095|
Recruitment Status : Completed
First Posted : March 26, 2014
Last Update Posted : February 1, 2017
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||3253 participants|
|Official Title:||Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 30, 2016|
|Actual Study Completion Date :||November 30, 2016|
TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018
Placebo administered on study TB-018
- Collect and store biological samples for future use to evaluate potential biological markers correlated to the risk for tuberculosis. [ Time Frame: 36 months in parallel with main study TB-018 (NCT01755598). ]Additional blood samples will be collected from participants that have agreed to be in this sub-study of TB-018 (NCT01755598).
- Collect and store biological samples for future use to evaluate immune correlates of protection from tuberculosis in subjects vaccinated with GSK 692342 (M72/AS01E). [ Time Frame: 36 months in parallel with main study TB-018 (NCT01755598). ]
Biospecimen Retention: Samples With DNA
Specimens for this sub-study are collected from an interventional Phase 2 study (TB-018 see NCT 01755598) and later analyzed for correlates of risk to tuberculosis.
PBMC/Plasma; Whole Blood cell count; Intracellular RNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097095
|Study Director:||Bernard Landry, MS||Aeras|