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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIR-1111 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIR-1111 | Biological | VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Day 1 through 14 days after first dose |
| Number of participants with any systemic reactogenicity event after second dose |
| Measure | Description | 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Miami | Florida | 33122 | United States | ||
| Investigative Site |
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| Placebo | Drug | A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection. |
|
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) | 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) | 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) | 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 |
| 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 | 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 | 0-36 weeks |
| Memory phenotype of CMV-specific CD4 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95. | 0-36 weeks |
| Memory phenotype of CMV-specific CD8 T cells via flow cytometry analysis of CD45RA, CCR7, CD27, CD28 AND/OR CD95 | 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 | 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 | 0-36 weeks |
| Binding titers of CMV-specific IgG antibodies | 0-36 weeks |
| Binding titers of HIV Clade A Gag-specific IgG antibodies | 0-36 weeks |
| Seattle |
| Washington |
| 98104 |
| United States |
| Investigative Site | Madison | Wisconsin | 53704 | United States |