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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 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 26 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03844386
The ClinicalTrials.gov registry entry for NCT03844386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 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 3 interventions - of which Placebo is the first listed.
NCT03844386 reports 0 study locations.
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.
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