- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04725877
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
February 24, 2023 updated by: Vir Biotechnology, Inc.
A Phase 1a, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of 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, 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33122
- Investigative Site
-
-
Washington
-
Seattle, Washington, United States, 98104
- Investigative Site
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53704
- Investigative Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.
|
Experimental: VIR-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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with any treatment-emergent adverse events (AEs)
Time Frame: Day 1 through 36 weeks
|
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.
|
Day 1 through 36 weeks
|
Number of participants with any serious AEs (SAEs)
Time Frame: Day 1 through 36 weeks
|
An SAE is any life-threatening event or one that results in hospitalization, significant disability/incapacity, death or congenital anomaly/birth defect.
|
Day 1 through 36 weeks
|
Number of participants with any local site reactogenicity event after first dose
Time Frame: Day 1 through 14 days 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.
|
Day 1 through 14 days after first dose
|
Number of participants with any local site reactogenicity event after second dose
Time Frame: Day 1 through 14 days 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.
|
Day 1 through 14 days after second dose
|
Number of participants with any systemic reactogenicity event after first dose
Time Frame: Day 1 through 14 days 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.
|
Day 1 through 14 days after first dose
|
Number of participants with any systemic reactogenicity event after second dose
Time Frame: Day 1 through 14 days 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.
|
Day 1 through 14 days after second dose
|
Number of participants with any treatment-emergent clinical laboratory abnormalities (chemistry, hematology and liver function tests)
Time Frame: Day 1 through 36 weeks
|
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.
|
Day 1 through 36 weeks
|
Number of participants with CMV vector viremia (blood)
Time Frame: Day 1 through 36 weeks
|
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.
|
Day 1 through 36 weeks
|
Number of participants with CMV vector shedding (urine and saliva)
Time Frame: Day 1 through 36 weeks
|
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.
|
Day 1 through 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
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
|
0-36 weeks
|
Binding titers of CMV-specific IgG antibodies
Time Frame: 0-36 weeks
|
0-36 weeks
|
Binding titers of HIV Clade A Gag-specific IgG antibodies
Time Frame: 0-36 weeks
|
0-36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2020
Primary Completion (Actual)
December 5, 2022
Study Completion (Actual)
December 5, 2022
Study Registration Dates
First Submitted
January 8, 2021
First Submitted That Met QC Criteria
January 21, 2021
First Posted (Actual)
January 27, 2021
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 24, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- VIR-1111-2001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV I Infection
-
Beckman Coulter, Inc.CompletedHIV I Infection | HIV-2 InfectionFrance
-
Erasmus Medical CenterNot yet recruitingHIV Infections | Hiv | HIV-1-infection | HIV I InfectionNetherlands
-
Allegheny Singer Research Institute (also known...Active, not recruitingHIV Infections | HIV-1-infection | HIV I InfectionUnited States
-
University of ConnecticutMedical Research Council, South AfricaRecruitingHIV I InfectionUnited States
-
Hospital Civil de GuadalajaraCompleted
-
State University of New York - Downstate Medical...National Institute of Mental Health (NIMH); Yale UniversityEnrolling by invitationHIV I InfectionUnited States
-
Bionor Immuno ASCelgene CorporationCompleted
-
Bionor Immuno ASCompletedHIV I InfectionGermany, United States, Spain, United Kingdom, Italy
-
Biomedical Research and Training Institute, ZimbabweGilead SciencesCompletedHIV I Infection | ARTZimbabwe
Clinical Trials on VIR-1111
-
ShireTerminatedLate Infantile Metachromatic LeukodystrophyDenmark
-
Vir Biotechnology, Inc.RecruitingHepatitis D, ChronicNew Zealand, United Kingdom, France, Moldova, Republic of, Romania, Bulgaria, Germany, Italy, Netherlands
-
Assistance Publique - Hôpitaux de ParisShire; Zymenex A/S; European Leukodystrophy AssociationCompletedMetachromatic LeukodystrophyFrance
-
Vir Biotechnology, Inc.RecruitingCirrhosis | Hepatic ImpairmentUnited States
-
Vir Biotechnology, Inc.RecruitingHepatitis B, ChronicHong Kong, Korea, Republic of, Malaysia, New Zealand, Taiwan, United Kingdom, Romania, United States, Moldova, Republic of, Canada, Germany, Ukraine
-
Vir Biotechnology, Inc.Terminated
-
Vir Biotechnology, Inc.RecruitingA Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218Renal ImpairmentUnited States
-
ShireCompletedLate Infantile Metachromatic LeukodystrophyDenmark
-
The Center for the Biology of Chronic DiseaseCompletedEpstein-Barr Virus Infections | Cytomegalovirus Infections | Human Papillomavirus | Herpes Simplex Infections | Varicella-zoster Virus InfectionUnited States