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

Vir Biotechnology, Inc.27 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

HIV I Infection

Interventions

VIR-1111BIOLOGICAL

VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.

PlaceboDRUG

A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Investigative Site

Miami, Florida, United States

Investigative Site

Seattle, Washington, United States

Investigative Site

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 1 through 36 weeks

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.

Time frame: Day 1 through 36 weeks

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.

Time frame: Day 1 through 14 days after first dose

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.

Time frame: Day 1 through 14 days after second dose

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.

Time frame: Day 1 through 14 days after first dose

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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 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

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

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

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

Binding titers of CMV-specific IgG antibodies

Time frame: 0-36 weeks

Binding titers of HIV Clade A Gag-specific IgG antibodies

Time frame: 0-36 weeks