A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A

September 14, 2023 updated by: Vir Biotechnology, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2985

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Investigative Site
      • Mobile, Alabama, United States, 36608
        • Investigative Site
    • Arizona
      • Tempe, Arizona, United States, 85281
        • Investigative Site
    • California
      • Long Beach, California, United States, 90805
        • Investigative Site
      • Pomona, California, United States, 91767
        • Investigative Site
      • San Diego, California, United States, 92123
        • Investigative Site
    • Colorado
      • Aurora, Colorado, United States, 80918
        • Investigative Site
      • Longmont, Colorado, United States, 80501
        • Investigative Site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Investigative Site
      • Jupiter, Florida, United States, 33458
        • Investigative Site
      • Miami, Florida, United States, 33144
        • Investigative Site
      • Miami, Florida, United States, 33165
        • Investigative Site
      • Pembroke Pines, Florida, United States, 33024
        • Investigative Site
      • Winter Park, Florida, United States, 32789
        • Investigative Site
    • Georgia
      • Lilburn, Georgia, United States, 30047
        • Investigative Site
    • Idaho
      • Meridian, Idaho, United States, 83642
        • Investigative Site
    • Illinois
      • Chicago, Illinois, United States, 60625
        • Investigative Site
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Investigative Site
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Investigative Site
      • Lenexa, Kansas, United States, 66219
        • Investigative Site
      • Wichita, Kansas, United States, 67205
        • Investigative Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Investigative Site
      • Versailles, Kentucky, United States, 40383
        • Investigative Site
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Investigative Site
      • New Orleans, Louisiana, United States, 70115
        • Investigative Site
    • Massachusetts
      • Methuen, Massachusetts, United States, 01844
        • Investigative Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States, 89030
        • Investigative Site
      • Las Vegas, Nevada, United States, 89102
        • Investigative Site
    • New York
      • Rochester, New York, United States, 14618
        • Investigative Site
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Investigative Site
      • Raleigh, North Carolina, United States, 27612
        • Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Investigative Site
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Investigative Site
      • Yukon, Oklahoma, United States, 73099
        • Investigative Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Investigative Site
      • North Charleston, South Carolina, United States, 29405
        • Investigative Site
      • Spartanburg, South Carolina, United States, 29303
        • Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Investigative Site
    • Tennessee
      • Elizabethton, Tennessee, United States, 37643
        • Investigative Site
      • Knoxville, Tennessee, United States, 37909
        • Investigative Site
    • Texas
      • Austin, Texas, United States, 78705
        • Investigative Site
      • Austin, Texas, United States, 78745
        • Investigative Site
      • Cedar Park, Texas, United States, 78613
        • Investigative Site
      • Dallas, Texas, United States, 75251
        • Investigative Site
      • Houston, Texas, United States, 77055
        • Investigative Site
      • San Angelo, Texas, United States, 76904
        • Investigative Site
      • San Antonio, Texas, United States, 78229
        • Investigative Site
      • Tomball, Texas, United States, 77375
        • Investigative Site
    • Utah
      • Layton, Utah, United States, 84041
        • Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 62 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Biological: Placebo
Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection
Experimental: VIR-2482 (Dose 1)
Biological: VIR-2482 (dose 1)
VIR-2482 given by intramuscular injection
Experimental: VIR-2482 (Dose 2)
Biological: VIR-2482 (dose 2)
VIR-2482 given by intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to Week 84
Occurrence of adverse events (AEs)
Time Frame: Up to Week 84
Up to Week 84
Occurrence of serious adverse events (SAEs)
Time Frame: Up to Week 84
Up to Week 84
Occurrence of adverse events of special interest (AESI)
Time Frame: Up to Week 84
Up to Week 84
Percentage of Participants with Abnormalities in Vital Signs
Time Frame: Up to Week 84
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
Up to Week 84
Percentage of Participants with Clinically significant Abnormalities in Clinical Laboratory Tests
Time Frame: Up to Week 84
Percentage of participants with abnormalities in clinical laboratory test (including hematology, Chemistry, Coagulation, and Urinalysis) will be reported
Up to Week 84

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR)
Time Frame: Up to Week 84
Up to Week 84
Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR)
Time Frame: Up to Week 84
Up to Week 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vir Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2022

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

September 24, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

September 18, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIR-2482-4002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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