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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097095
• Other study ID #: C-041-972
• Status: Completed
• Phase: N/A
• First received: March 24, 2014
• Last updated: January 31, 2017
• Start date: August 2014
• Est. completion date: November 30, 2016

Study information

• Verified date: January 2017
• Source: Aeras
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Additional information in the protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3253
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aeras	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).