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

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.

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

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.

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