Clinical trial NCT04725877: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV I Infection
Keywords: HIV
Vaccine
CMV
Cytomegalovirus
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2021-01-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Number of participants with any treatment-emergent adverse events (AEs)
timeFrame: Day 1 through 36 weeks
measure: Number of participants with any serious AEs (SAEs)
timeFrame: Day 1 through 36 weeks
measure: Number of participants with any local site reactogenicity event after first dose
timeFrame: Day 1 through 14 days after first dose
measure: Number of participants with any local site reactogenicity event after second dose
timeFrame: Day 1 through 14 days after second dose
measure: Number of participants with any systemic reactogenicity event after first dose
timeFrame: Day 1 through 14 days after first dose
measure: Number of participants with any systemic reactogenicity event after second dose
timeFrame: Day 1 through 14 days after second dose
measure: Number of participants with any treatment-emergent clinical laboratory abnormalities (chemistry, hematology and liver function tests)
timeFrame: Day 1 through 36 weeks
measure: Number of participants with CMV vector viremia (blood)
timeFrame: Day 1 through 36 weeks
measure: Number of participants with CMV vector shedding (urine and saliva)
timeFrame: Day 1 through 36 weeks
Secondary outcomes:
measure: 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
timeFrame: 0-36 weeks
measure: 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
timeFrame: 0-36 weeks
measure: 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
timeFrame: 0-36 weeks
measure: 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
timeFrame: 0-36 weeks
measure: Memory phenotype of CMV-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95.
timeFrame: 0-36 weeks
measure: Memory phenotype of CMV-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95
timeFrame: 0-36 weeks
measure: Memory phenotype of HIV-1 Clade A Gag-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95
timeFrame: 0-36 weeks
measure: Memory phenotype of HIV-1 Clade A Gag-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95
timeFrame: 0-36 weeks
measure: Binding titers of CMV-specific IgG antibodies
timeFrame: 0-36 weeks
measure: Binding titers of HIV Clade A Gag-specific IgG antibodies
timeFrame: 0-36 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Seattle
country: United States
facility: Investigative Site
state: Washington
city: Madison
country: United States
facility: Investigative Site
state: Wisconsin
Study officials:
References: