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NCT05604209 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT05604209 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants.
The verdict
NCT05604209, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a double blind, randomized, placebo-controlled, parallel design study in which 18 in participants with HIV (PWH) on suppressive antiretroviral therapy will be randomly assigned to receive vaccination with C62 followed by M4 (C62-M4), C62 and C1 followed by M4 and M3 (C1C62-M3M4), or placebo. The purpose of this study is to find out: * If it is safe for people to receive intramuscular (IM) vaccination with C62-M4 or C1C62-M3M4 * If giving participants these vaccine doses will improve their immune system response to help the body get rid of HIV in the cells
Interventions
- OTHER Placebo
- BIOLOGICAL ChAdOx1.tHIVconsv1
- BIOLOGICAL ChAdOx1.HIVconsv62
- BIOLOGICAL MVA.tHIVconsv3
- BIOLOGICAL MVA.tHIVconsv4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-10-13 |
| Est. Completion | 2025-01-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05604209
The ClinicalTrials.gov registry entry for NCT05604209 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT05604209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05604209 about?
NCT05604209 is a clinical study titled "Safety and Immunogenicity of HIV-1 Vaccines C62-M4 or C1C62-M3M4 in Persons With HIV-1 Suppressed on ART". This is a double blind, randomized, placebo-controlled, parallel design study in which 18 in participants with HIV (PWH) on suppressive antiretroviral therapy will be randomly assigned to receive vaccination with C62 followed by M4 (C62-M4), C62 and C1 followed by M4 and M3 (C1C62-M3M4), or placebo....
What is the current status of trial NCT05604209?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2022-10-13. Estimated completion is 2025-01-10.
What interventions are being tested in trial NCT05604209?
The interventions under investigation include: Placebo (OTHER), ChAdOx1.tHIVconsv1 (BIOLOGICAL), ChAdOx1.HIVconsv62 (BIOLOGICAL), MVA.tHIVconsv3 (BIOLOGICAL), MVA.tHIVconsv4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05604209?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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