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

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ClinicalTrials.gov Identifier: NCT04725877
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : June 11, 2021
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Tracking Information
First Submitted Date  ICMJE January 8, 2021
First Posted Date  ICMJE January 27, 2021
Last Update Posted Date June 11, 2021
Actual Study Start Date  ICMJE December 28, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2021)
  • 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 TNFa [ Time Frame: 0-36 weeks ]
  • 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 ]
  • 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 [ Time Frame: 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 ]
  • Polyfunctionality of CMV-specific CD4 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect all combinations of IL-2, IFNg, TNFa, CD154, IL-17, MIP-1b, CD107a AND/OR Granzyme B [ Time Frame: 0-36 weeks ]
  • Polyfunctionality of CMV-specific CD8 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect all combinations of IL-2, IFNg, TNFa, CD154, IL-17, MIP-1b, CD107a AND/OR Granzyme B [ Time Frame: 0-36 weeks ]
  • Polyfunctionality of HIV-1 Clade A Gag-specific CD4 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect all combinations of IL-2, IFNg, TNFa, CD154, IL-17, MIP-1b, CD107a AND/OR Granzyme B [ Time Frame: 0-36 weeks ]
  • Polyfunctionality of HIV-1 Clade A Gag-specific CD8 T cells via peptide stimulation, intracellular cytokine staining and flow cytometry to detect all combinations of IL-2, IFNg, TNFa, CD154, IL-17, MIP-1b, CD107a AND/OR Granzyme B [ Time Frame: 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE HIV I Infection
Intervention  ICMJE
  • Biological: 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.
  • Drug: Placebo
    A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.
Study Arms  ICMJE
  • Experimental: VIR-1111
    Intervention: Biological: VIR-1111
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 21, 2021)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Inquiry +1 415-654-5281 clinicaltrials@vir.bio
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04725877
Other Study ID Numbers  ICMJE VIR-1111-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vir Biotechnology, Inc.
Study Sponsor  ICMJE Vir Biotechnology, Inc.
Collaborators  ICMJE Bill and Melinda Gates Foundation
Investigators  ICMJE Not Provided
PRS Account Vir Biotechnology, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP