Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis
1 other identifier
observational
3,253
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedFebruary 1, 2017
January 1, 2017
2.3 years
March 24, 2014
January 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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).
Study Arms (2)
Vaccine group
TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018
Placebo Comparator
Placebo administered on study TB-018
Eligibility Criteria
Subjects who have consented to participate in TB-018 will be approached for participation in this sub-study. Subjects who have consented to participate in TB-018 are not required to participate in this sub-study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aeraslead
- GlaxoSmithKlinecollaborator
Biospecimen
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bernard Landry, MS
Aeras
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 26, 2014
Study Start
August 1, 2014
Primary Completion
November 30, 2016
Study Completion
November 30, 2016
Last Updated
February 1, 2017
Record last verified: 2017-01
Data Sharing
- IPD Sharing
- Will not share