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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2985

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings