A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
Primary Purpose
Influenza A
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VIR-2482 (dose 1)
VIR-2482 (dose 2)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza A focused on measuring Flu
Eligibility Criteria
Inclusion Criteria:
- Participant must be 18 to < 65 years of age, at time of randomization
- Participants must be in good health, determined from medical history and no clinically significant findings from physical examination, 12-lead electrocardiogram (ECG), vital signs, and laboratory values
Exclusion Criteria:
- History or clinical evidence of conditions considered high risk for developing influenza-related complications
- History of confirmed influenza infection within 3 months prior to randomization.
- Febrile illness with or without respiratory symptoms
- History of malignancy within 5 years or participant is under evaluation for malignancy.
- Any condition or receipt of any medication contraindicating IM injection, as judged by the investigator.
- History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis
- Participant has a clinically significant medical condition, physical exam finding, or abnormal laboratory result.
- Prior or planned receipt of any influenza vaccine for the upcoming season.
- Received any investigational agent within 90 days or within 5 half-lives of the investigational agent.
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
VIR-2482 (Dose 1)
VIR-2482 (Dose 2)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants with protocol-defined ILI with confirmed influenza A (by reverse transcription-polymerase chain reaction [RT-PCR])
Occurrence of adverse events (AEs)
Occurrence of serious adverse events (SAEs)
Occurrence of adverse events of special interest (AESI)
Percentage of Participants with Abnormalities in Vital Signs
Percentage of participants with abnormalities in vital signs (temperature, systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate and respiratory rate) will be reported
Percentage of Participants with Clinically significant Abnormalities in Clinical Laboratory Tests
Percentage of participants with abnormalities in clinical laboratory test (including hematology, Chemistry, Coagulation, and Urinalysis) will be reported
Secondary Outcome Measures
Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR)
Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR)
Full Information
NCT ID
NCT05567783
First Posted
September 24, 2022
Last Updated
September 14, 2023
Sponsor
Vir Biotechnology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05567783
Brief Title
A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
Official Title
A Double-Blind, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
VIR-2482 did not achieve its primary efficacy endpoint in the prevention of seasonal Influenza A illness via intramuscular administration.
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vir Biotechnology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of VIR-2482 compared to placebo in preventing influenza A illness in healthy adults 18 to <65 years of age without pre-existing risk factors for serious complications from influenza infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A
Keywords
Flu
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2985 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIR-2482 (Dose 1)
Arm Type
Experimental
Arm Title
VIR-2482 (Dose 2)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
VIR-2482 (dose 1)
Intervention Description
VIR-2482 given by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
VIR-2482 (dose 2)
Intervention Description
VIR-2482 given by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection
Primary Outcome Measure Information:
Title
Proportion of participants with protocol-defined ILI with confirmed influenza A (by reverse transcription-polymerase chain reaction [RT-PCR])
Time Frame
Up to Week 84
Title
Occurrence of adverse events (AEs)
Time Frame
Up to Week 84
Title
Occurrence of serious adverse events (SAEs)
Time Frame
Up to Week 84
Title
Occurrence of adverse events of special interest (AESI)
Time Frame
Up to Week 84
Title
Percentage of Participants with Abnormalities in Vital Signs
Description
Percentage of participants with abnormalities in vital signs (temperature, systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate and respiratory rate) will be reported
Time Frame
Up to Week 84
Title
Percentage of Participants with Clinically significant Abnormalities in Clinical Laboratory Tests
Description
Percentage of participants with abnormalities in clinical laboratory test (including hematology, Chemistry, Coagulation, and Urinalysis) will be reported
Time Frame
Up to Week 84
Secondary Outcome Measure Information:
Title
Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR)
Time Frame
Up to Week 84
Title
Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR)
Time Frame
Up to Week 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant must be 18 to < 65 years of age, at time of randomization
Participants must be in good health, determined from medical history and no clinically significant findings from physical examination, 12-lead electrocardiogram (ECG), vital signs, and laboratory values
Exclusion Criteria:
History or clinical evidence of conditions considered high risk for developing influenza-related complications
History of confirmed influenza infection within 3 months prior to randomization.
Febrile illness with or without respiratory symptoms
History of malignancy within 5 years or participant is under evaluation for malignancy.
Any condition or receipt of any medication contraindicating IM injection, as judged by the investigator.
History of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis
Participant has a clinically significant medical condition, physical exam finding, or abnormal laboratory result.
Prior or planned receipt of any influenza vaccine for the upcoming season.
Received any investigational agent within 90 days or within 5 half-lives of the investigational agent.
Facility Information:
Facility Name
Investigative Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Investigative Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Facility Name
Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Facility Name
Investigative Site
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Investigative Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Facility Name
Investigative Site
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Investigative Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Investigative Site
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Investigative Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Investigative Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Investigative Site
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
Investigative Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Investigative Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Investigative Site
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Investigative Site
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Investigative Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Investigative Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Investigative Site
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383
Country
United States
Facility Name
Investigative Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigative Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Investigative Site
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Investigative Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Investigative Site
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
Facility Name
Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Investigative Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Investigative Site
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Investigative Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Investigative Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Facility Name
Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Investigative Site
City
Elizabethton
State/Province
Tennessee
ZIP/Postal Code
37643
Country
United States
Facility Name
Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Investigative Site
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Investigative Site
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigative Site
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Investigative Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
We'll reach out to this number within 24 hrs