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NCT03844386 · ClinicalTrials.gov registry record · Phase 1
Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT03844386: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT03844386 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03844386, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3), MVA.tHIVconsv4 (M4), M3+M4 combined, or placebo. Participants will be randomized 7:7:7:3 to one of four study arms, and receive study treatment or placebo at Day 0. Each enrolled participant will complete the study in approximately 33.5 weeks (8.4 months). The purpose of this study is to find out: * If it is safe for people to receive injections of two investigational HIV vaccines, called MVAtHIVconsv3 and MVAtHIVconsv4 alone or in combination. * If giving participants these vaccine doses will increase their immune system's ability to kill HIV virus.
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 will be used to measure safety where Grade 3 is defined as severe and Grade 4 is defined as potentially life-threatening. Treatment-Related AEs will be assessments that are considered related to study product as possible, probable, or definite as defined in the protocol.
Interventions
- OTHER Placebo
- BIOLOGICAL MVA.tHIVconsv3
- BIOLOGICAL MVA.tHIVconsv4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2022-04-04 |
| Phase | Phase 1 |
What the finished NCT03844386 record still lists
NCT03844386 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03844386 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03844386 about?
NCT03844386 is a clinical study titled "Study to Assess Safety and Ability to Induce Immune Responses of HIV-1 Vaccines M3 and M4 Given Alone or in Combination in HIV-infected Adults". This is a double blind, randomized, placebo-controlled, parallel design, study in which 24 HIV-infected participants with durable viral suppression will be randomly assigned to receive vaccination with MVA.tHIVconsv3 (M3), MVA.tHIVconsv4 (M4), M3+M4 combined, or placebo. Participants will be randomi...
What is the current status of trial NCT03844386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-04-22. Estimated completion is 2022-04-04.
What interventions are being tested in trial NCT03844386?
The interventions under investigation include: Placebo (OTHER), MVA.tHIVconsv3 (BIOLOGICAL), MVA.tHIVconsv4 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03844386?
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 NCT03844386's enrollment target sits among peer trials
26 1482nd of 2000 higher than 506 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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