Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04725877 | VIR-1111: A Prototype Human CMV-based Vaccine for Human Immunodeficiency Virus (HIV) in Healthy Volunteers | PHASE1 | COMPLETED | 27 | — | — | Dec 28, 2020 | Dec 5, 2022 | Feb 27, 2023 | 3 | United States |
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.
An SAE is any life-threatening event or one that results in hospitalization, significant disability/incapacity, death or congenital anomaly/birth defect.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| VIR-1111 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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. |
| Placebo | DRUG | A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection. |
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 ...