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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: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT05604209 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs were assessments that were considered related to study product as possible, probable, or definite as defined in the protocol. Confidence intervals around percent
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 |
What the finished NCT05604209 record still lists
NCT05604209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT05604209 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05604209's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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