Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)

Study Overview
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Brief Summary
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This is an independent optional sub-study parallel to TB-018 (NCT01755598) in which biological samples will be collected for future investigations on biological correlates, markers or prognostic factors for TB disease. Subjects who consent to enroll in TB-018, A phase IIb, double-blind, randomised, placebo-controlled study to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate tuberculosis (TB) vaccine GSK 692342 (M72/AS01E) against TB disease, in healthy adults aged 18-50 years, living in a TB endemic region, (see NCT 01755598) will be asked to participate in this sub-study. Subjects enrolled in TB-018 who also consent to C-041-972 will be followed according to the TB-018 protocol but will have additional blood samples collected for the sub-study.

Detailed Description
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Additional information in the protocol

Official Title
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Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis

Conditions
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Tuberculosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for inclusion criteria into TB-018. Exclusion criteria: To be eligible for this sub-study, subjects must be enrolled in TB-018 and provide separate written informed consent for C-041-972. See NCT 01755598 for exclusion criteria into TB-018.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaccine group<br>TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018 | |
| Placebo Comparator<br>Placebo administered on study TB-018 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and store biological samples for future use to evaluate potential biological markers correlated to the risk for tuberculosis. | Additional blood samples will be collected from participants that have agreed to be in this sub-study of TB-018 (NCT01755598). | 36 months in parallel with main study TB-018 (NCT01755598). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collect and store biological samples for future use to evaluate immune correlates of protection from tuberculosis in subjects vaccinated with GSK 692342 (M72/AS01E). |  | 36 months in parallel with main study TB-018 (NCT01755598). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Correlates of risk, Tuberculosis, Sub-study, TB, TB-018