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

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Aeras

ClinicalTrials.gov Identifier:

NCT02097095

First received: March 24, 2014

Last updated: January 31, 2017

Last verified: January 2017

History of Changes

Purpose

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.

Condition
Tuberculosis


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Other
Official Title:	Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by Aeras:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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


Enrollment:	3253
Study Start Date:	August 2014
Study Completion Date:	November 30, 2016
Primary Completion Date:	November 30, 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts
Vaccine group TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018
Placebo Comparator Placebo administered on study TB-018

Detailed Description:

Additional information in the protocol

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

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.

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02097095

Sponsors and Collaborators

Aeras

GlaxoSmithKline

Investigators


Study Director:	Bernard Landry, MS	Aeras

More Information


Responsible Party:	Aeras
ClinicalTrials.gov Identifier:	NCT02097095 History of Changes
Other Study ID Numbers:	C-041-972
Study First Received:	March 24, 2014
Last Updated:	January 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Aeras:


Correlates of risk TB Tuberculosis Sub-study TB-018

Additional relevant MeSH terms:


Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections

ClinicalTrials.gov processed this record on July 17, 2017

To Top