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NCT04725877 · ClinicalTrials.gov registry record · Phase 1
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
A Phase 1 study of HIV I Infection, sponsored by Vir Biotechnology.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 3
- Study locations
NCT04725877: Completed Phase 1 study of HIV I Infection, sponsored by Vir Biotechnology.
NCT04725877 is a Phase 1 study of HIV I Infection that has completed, run by Vir Biotechnology. The registered enrollment target is 27 participants, below the 2,099-participant average among 5 other HIV I Infection trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04725877, a Phase 1 study of HIV I Infection, has completed, sponsored by Vir Biotechnology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 1a, first in human study in which healthy adult participants who are considered to be at low-risk for HIV infection and are seropositive for cytomegalovirus (CMV) will receive two doses of VIR-1111 or placebo. These participants will be assessed for safety, reactogenicity, tolerability and immunogenicity. There is an optional long-term follow-up study that would lengthen study participation for up to 3 years post-first dose.
Primary Outcome
A treatment-emergent AE is any AE with an onset date on or after the investigational product start date and no later than 36 weeks after permanent discontinuation of the investigational product.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL VIR-1111
Study Locations (3)
Florida
- Investigative Site - Miami
Washington
- Investigative Site - Seattle
Wisconsin
- Investigative Site - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2020-12-28 |
| Est. Completion | 2022-12-05 |
| Phase | Phase 1 |
What the finished NCT04725877 record still lists
NCT04725877 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 2,099-participant average among 5 other HIV I Infection trials with a reported enrollment target (99% lower).
The record links to 1 condition, with HIV I Infection appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04725877 reports a single indexed study location in Florida, Washington, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04725877 about?
NCT04725877 is a clinical study titled "VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers". This is a Phase 1a, first in human study in which healthy adult participants who are considered to be at low-risk for HIV infection and are seropositive for cytomegalovirus (CMV) will receive two doses of VIR-1111 or placebo. These participants will be assessed for safety, reactogenicity, tolerabili...
What is the current status of trial NCT04725877?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2020-12-28. Estimated completion is 2022-12-05.
What conditions does trial NCT04725877 study?
This clinical trial studies the following conditions: HIV I Infection.
What interventions are being tested in trial NCT04725877?
The interventions under investigation include: Placebo (DRUG), VIR-1111 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04725877?
This trial is sponsored by Vir Biotechnology, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04725877 being conducted?
This trial has 3 study locations across Florida, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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