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NCT04983030 · ClinicalTrials.gov registry record · Phase 1
Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults
A Phase 1 study of HIV and Acquired Immunodeficiency Syndrome, sponsored by Boris Juelg, MD PhD.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 6
- Study locations
NCT04983030: Active Phase 1 study of HIV and Acquired Immunodeficiency Syndrome, sponsored by Boris Juelg, MD PhD.
NCT04983030 is a Phase 1 study of HIV and Acquired Immunodeficiency Syndrome that is active but no longer recruiting, run by Boris Juelg, MD PhD. The registered enrollment target is 36 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04983030, a Phase 1 study of HIV and Acquired Immunodeficiency Syndrome, is active but no longer recruiting, sponsored by Boris Juelg, MD PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 6
- Study locations
Study Summary
A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
Primary Outcome
Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
Conditions Studied
Interventions
- BIOLOGICAL VRC07-523LS
- BIOLOGICAL Ad26.Mos4.HIV
- BIOLOGICAL MVA-BN-HIV
- BIOLOGICAL PGT121
- BIOLOGICAL PGDM1400
Study Locations (6)
California
- UCLA CARE (Center for AIDs Research and Education) - Los Angeles
Florida
- Orlando Immunology Center - Orlando
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Missouri
- Washington University Clinical Trials Unit - St Louis
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Washington
- University of Washington Positive Research - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
What the registry record for NCT04983030 still lists
NCT04983030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (92% lower).
The record links to 5 conditions, with HIV appearing as the primary indexed condition, and to 5 interventions - of which VRC07-523LS is the first listed.
NCT04983030 lists 6 locations in 6 states (California, Florida, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04983030 about?
NCT04983030 is a clinical study titled "Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults". A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in ...
What is the current status of trial NCT04983030?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-04-01. Estimated completion is 2026-04-30.
What conditions does trial NCT04983030 study?
This clinical trial studies the following conditions: HIV, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Viral, Retroviridae Infections, Immunologic Deficiency Syndrome, Acquired.
What interventions are being tested in trial NCT04983030?
The interventions under investigation include: VRC07-523LS (BIOLOGICAL), Ad26.Mos4.HIV (BIOLOGICAL), MVA-BN-HIV (BIOLOGICAL), PGT121 (BIOLOGICAL), PGDM1400 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04983030?
This trial is sponsored by Boris Juelg, MD PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04983030 being conducted?
This trial has 6 study locations across California, Florida, Massachusetts, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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