Back to resultsVIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
Primary Purpose
HIV I Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
VIR-1111
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for HIV I Infection focused on measuring HIV, Vaccine, CMV, Cytomegalovirus
Eligibility Criteria
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
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
VIR-1111
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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
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
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
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
Memory phenotype of CMV-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95.
Memory phenotype of CMV-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95
Memory phenotype of HIV-1 Clade A Gag-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95
Memory phenotype of HIV-1 Clade A Gag-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95
Binding titers of CMV-specific IgG antibodies
Binding titers of HIV Clade A Gag-specific IgG antibodies
Full Information
NCT ID
NCT04725877
First Posted
January 8, 2021
Last Updated
February 24, 2023
Sponsor
Vir Biotechnology, Inc.
Collaborators
Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04725877
Brief Title
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.
Collaborators
Bill and Melinda Gates Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV I Infection
Keywords
HIV, Vaccine, CMV, Cytomegalovirus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIR-1111
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
VIR-1111
Intervention Description
VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.
Primary Outcome Measure Information:
Title
Number of participants with any treatment-emergent adverse events (AEs)
Description
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
Title
Number of participants with any serious AEs (SAEs)
Description
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
Title
Number of participants with any local site reactogenicity event after first dose
Description
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
Title
Number of participants with any local site reactogenicity event after second dose
Description
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
Title
Number of participants with any systemic reactogenicity event after first dose
Description
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
Title
Number of participants with any systemic reactogenicity event after second dose
Description
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
Title
Number of participants with any treatment-emergent clinical laboratory abnormalities (chemistry, hematology and liver function tests)
Description
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
Title
Number of participants with CMV vector viremia (blood)
Description
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
Title
Number of participants with CMV vector shedding (urine and saliva)
Description
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
Binding titers of CMV-specific IgG antibodies
Time Frame
0-36 weeks
Title
Binding titers of HIV Clade A Gag-specific IgG antibodies
Time Frame
0-36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33122
Country
United States
Facility Name
Investigative Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Investigative Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
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