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CompletedNCT04725877Updated Feb 27, 2023

VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers

A Phase 1 interventional study of VIR-1111 and Placebo in HIV I Infection, sponsored by Vir Biotechnology, Inc.. Completed at 3 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Vir Biotechnology, Inc. · Phase 1, Interventional, and Prevention

From the registry’s dates

  • Primary completion was Dec 2022, 3 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

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.

02

Conditions studied

  • HIV I Infection

Keywords

  • HIV
  • Vaccine
  • CMV
  • Cytomegalovirus
03

In context

Lead sponsor

Vir Biotechnology, Inc. is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 11 (73%) have results posted.

Browse Vir Biotechnology, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy males or healthy females of non-child-bearing potential between the ages of 18 to 50 at the time of screening
  • Positive CMV serostatus
  • Assessed by clinic staff as being low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last protocol visit
  • Willing to use condoms during intercourse through Week 36 or the end of the study
  • Willing to undergo HIV testing, risk reduction counseling, and receive HIV test results
  • Willing to comply with the protocol requirements regarding donation of blood, sperm or other tissues
  • In the opinion of the Investigator, generally in good health as determined from medical history and no clinically significant findings from physical examinations, vital signs, and laboratory values

Exclusion criteria

Exclusion Criteria:

  • Live in a home with children under the age of 6
  • Routine provision of child care to children under the age of 6
  • Have close contact with immunocompromised individuals
  • Have close contact with pregnant women or a partner planning to become pregnant during the course of the study
  • Health care provider who routinely comes into contact with immunosuppressed patients or pregnant women
  • Participant is immunocompromised
  • Participant has an autoimmune disorder
  • Positive HIV test at the time of study screening
  • Receipt of another investigational HIV or CMV vaccine candidate
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    VIR-1111

    Biological: VIR-1111

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • BiologicalVIR-1111

    VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.

  • DrugPlacebo

    A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.

06

What researchers measure

Primary outcomes

  1. Number of participants with any treatment-emergent adverse events (AEs)

    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.

    Time frame: Day 1 through 36 weeks

  2. Number of participants with any serious AEs (SAEs)

    An SAE is any life-threatening event or one that results in hospitalization, significant disability/incapacity, death or congenital anomaly/birth defect.

    Time frame: Day 1 through 36 weeks

  3. Number of participants with any local site reactogenicity event after first dose

    Signs and symptoms will be captured at the injection site (e.g., pain/tenderness, swelling, redness and induration) through self-assessment via participant diaries and in-person clinical assessments.

    Time frame: Day 1 through 14 days after first dose

  4. Number of participants with any local site reactogenicity event after second dose

    Signs and symptoms will be captured at the injection site (e.g., pain/tenderness, swelling, redness and induration) through self-assessment via participant diaries and in-person clinical assessments.

    Time frame: Day 1 through 14 days after second dose

  5. Number of participants with any systemic reactogenicity event after first dose

    Systemic signs and symptoms (fever, headache, fatigue, arthralgia, myalgia, malaise, nausea, vomiting or chills) through self-assessment via participant diaries and in-person clinical assessments.

    Time frame: Day 1 through 14 days after first dose

  6. Number of participants with any systemic reactogenicity event after second dose

    Systemic signs and symptoms (fever, headache, fatigue, arthralgia, myalgia, malaise, nausea, vomiting or chills) through self-assessment via participant diaries and in-person clinical assessments.

    Time frame: Day 1 through 14 days after second dose

  7. Number of participants with any treatment-emergent clinical laboratory abnormalities (chemistry, hematology and liver function tests)

    A treatment-emergent clinical laboratory abnormality is a clinical laboratory value that increases at least 1 toxicity grade from baseline at any postbaseline timepoint up to 30 days after permanent discontinuation of study drug. Clinical laboratory abnormalities are graded using DAIDS Table for Grading and Severity of Adult and Pediatric Events, Corrected Version 2.1, July 2017.

    Time frame: Day 1 through 36 weeks

  8. Number of participants with CMV vector viremia (blood)

    Quantitative polymerase chain reaction (qPCR) for CMV will be performed on participant blood samples collected throughout the study. Positive samples will undergo follow-up confirmatory PCR testing to differentiate wild-type CMV from CMV vaccine vector sequences.

    Time frame: Day 1 through 36 weeks

  9. Number of participants with CMV vector shedding (urine and saliva)

    Quantitative polymerase chain reaction (qPCR) for CMV will be performed on both saliva and urine samples collected from participants throughout the study to monitor for viral shedding. Positive samples will undergo follow-up confirmatory PCR testing to differentiate wild-type CMV from CMV vaccine vector sequences.

    Time frame: Day 1 through 36 weeks

Secondary outcomes

  1. Frequency of CMV-specific CD8 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect IL-2 AND/OR IFNg AND/OR TNFa

    Time frame: 0-36 weeks

  2. Frequency of CMV-specific CD4 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect IL-2 AND/OR IFNg AND/OR CD154

    Time frame: 0-36 weeks

  3. Frequency of HIV-1 Clade A Gag-specific CD4 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect IL-2 AND/OR IFNg AND/OR TNFa AND/OR CD154

    Time frame: 0-36 weeks

  4. Frequency of HIV-1 Clade A Gag-specific CD8 T cells T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect IL-2 AND/OR IFNg AND/OR TNFa

    Time frame: 0-36 weeks

  5. Memory phenotype of CMV-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95.

    Time frame: 0-36 weeks

  6. Memory phenotype of CMV-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95

    Time frame: 0-36 weeks

  7. Memory phenotype of HIV-1 Clade A Gag-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95

    Time frame: 0-36 weeks

  8. Memory phenotype of HIV-1 Clade A Gag-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95

    Time frame: 0-36 weeks

  9. Binding titers of CMV-specific IgG antibodies

    Time frame: 0-36 weeks

  10. Binding titers of HIV Clade A Gag-specific IgG antibodies

    Time frame: 0-36 weeks

07

Study locations

3 sites
  • Investigative Site
    Miami, Florida 33122, United States
  • Investigative Site
    Seattle, Washington 98104, United States
  • Investigative Site
    Madison, Wisconsin 53704, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in Dec 2022, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 8, 2021
First posted
Jan 27, 2021
StartActual
Dec 28, 2020
Primary completionActual
Dec 5, 2022
CompletionActual
Dec 5, 2022
Last update
Feb 27, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04725877
Lead sponsor
Vir Biotechnology, Inc.
Collaborators
Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Dec 28, 2020
Primary completion
Dec 5, 2022
Completion
Dec 5, 2022
Last update
Feb 27, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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