TuberculosisNCT02097095
Substudy of Protocol TB-018 (NCT01755598): Collection and Storage of Biological Samples for Evaluation of Correlates of TB (C-041-972)
An observational study of Tuberculosis, run by Aeras.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- Type of treatment
- Vaccines
- How many people
- 3,253 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to 30 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis
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.
Read the detailed description
Additional information in the protocol
- Conditions
- Tuberculosis
- Keywords
- Correlates of risk, TB, Tuberculosis, Sub-study, TB-018
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vaccine group | TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018 | |
| Placebo Comparator | Placebo administered on study TB-018 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 36 months in parallel with main study TB-018 (NCT01755598).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startAug 2014
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 3,253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeras
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Bernard Landry, MS, Study director, Aeras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097095
- Sponsor's protocol ID
- C-041-972
- Status last verified
- Jan 2017
- First submitted
- 24 Mar 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substudy of GSK Protocol TB-018: Collection and Storage of Biological Samples for Evaluation of Correlates of Tuberculosis
- ClinicalTrials.gov ID
- NCT02097095
- Acronym / sponsor ID
- C-041-972
- Conditions
- Tuberculosis
- Keywords
- Correlates of risk, TB, Tuberculosis, Sub-study, TB-018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,253 participants (actual)
- Lead sponsor
- AerasUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2014
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Additional information in the protocol
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine group | – | –TB vaccine GSK 692342 (M72/AS01E) administered on study TB-018 |
| Placebo Comparator | – | –Placebo administered on study TB-018 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Landry, MS study director
Aeras
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Aeras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.