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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:
ClinicalTrials.gov Identifier:
NCT02097095
First Posted: March 26, 2014
Last Update Posted: February 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aeras
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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
First Submitted: March 24, 2014
First Posted: March 26, 2014
Last Update Posted: February 1, 2017
Last Verified: January 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