Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence
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ClinicalTrials.gov Identifier: NCT03512249 |
Recruitment Status :
Active, not recruiting
First Posted : April 30, 2018
Last Update Posted : February 22, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | April 19, 2018 | ||||
First Posted Date ICMJE | April 30, 2018 | ||||
Last Update Posted Date | February 22, 2024 | ||||
Actual Study Start Date ICMJE | January 31, 2019 | ||||
Actual Primary Completion Date | March 20, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
• Rate of TB disease recurrence (relapse or reinfection), defined as TB diagnosed by confirmation of Mtb by culture of sputum. [ Time Frame: During the period starting 14 days after the 2nd vaccination (V6= Day 70) and ending 12 months after the 2nd vaccination ] Efficacy of H56:IC31 compared to placebo in reducing the rate of recurrent TB disease (relapse or reinfection)
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate H56:IC31 in Preventing Rate of TB Recurrence | ||||
Official Title ICMJE | Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Evaluate Safety and Efficacy of H56:IC31 in Reducing the Rate of TB Disease Recurrence in HIV Negative Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis | ||||
Brief Summary | This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups.
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Detailed Description | This is a phase 2, double-blind, randomized (1:1), placebo-controlled trial with two parallel groups.
Preclinical data suggest H56:IC31 may be more efficacious if administered while patients are still on treatment. Following the national guidelines for TB treatment in South Africa and Tanzania, we will obtain sputum samples from patients towards the end of treatment at about the same time they are obtained within the national TB control programmes, and if the sputum is smear negative, the criterion for successful treatment within TB programmes, the individual will be eligible for randomization and vaccination towards the end of their six-month treatment period. As this is a proof of concept TB vaccine study, HIV positive individuals have been excluded as it is not yet known what effect HIV infection may have on the immune response to the vaccine. However, HIV positive individuals are an important population to include in future studies should efficacy be demonstrated in this study. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 2 Cohorts - H56:IC31 and Placebo. First 150 participants will be in a safety group with additional scheduled evaluations. Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The unblinded persons in the study are the study vaccine manager (and designee) who manages the participant inventory log(s) at the trial site, the unblinded site staff, and the unblinded clinical trial site monitor(s) responsible for monitoring the investigational product at the trial site. All unblinded persons must take care to not reveal individual participant treatment assignments to any blinded member of the study team. There is an unblinded contact person at the sponsor's site in order to manage queries from the unblinded site staff or the unblinded monitors in the trial. The study vaccine manager (and designee) should be a designated site team member, such as the study pharmacist. Unblinded site staff must not participate in the evaluation of adverse events. The randomization list will be provided by the unblinded statistician and will be implemented as a module in the eCRF. |
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Condition ICMJE | Tuberculosis, Pulmonary | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
831 | ||||
Original Estimated Enrollment ICMJE |
900 | ||||
Estimated Study Completion Date ICMJE | March 30, 2024 | ||||
Actual Primary Completion Date | March 20, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | South Africa, Tanzania | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03512249 | ||||
Other Study ID Numbers ICMJE | A-055 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | International AIDS Vaccine Initiative | ||||
Original Responsible Party | Aeras | ||||
Current Study Sponsor ICMJE | International AIDS Vaccine Initiative | ||||
Original Study Sponsor ICMJE | Aeras | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | International AIDS Vaccine Initiative | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |