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

NCT05567783
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Phase
Phase 2
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Recruitment status
Terminated
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Participants
2,977
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Lead sponsor
Vir Biotechnology, Inc.
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Start date
2022-10-30
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Number of sites
51
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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.
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Short title
A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
clinicaltrials.gov
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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Terminated
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Phase
Phase 2
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Study type
Interventional
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Reason stopped
VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint
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Completion date
2023-08-31
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First posted
2022-10-05
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Registry last updated
2024-09-19
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Primary completion date
2023-05-05
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Start date
2022-10-30
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Actual participants
2,977
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Participants
2,977
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
51
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Vir Biotechnology, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05567783
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ClinicalTrials.gov ID
NCT05567783
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])

    Timeframe: Up to 24 Weeks

    Protocol-defined ILI with confirmed influenza A defined as RT-PCR confirmed influenza A with at least one respiratory symptom and at least one systemic symptom

  2. Number of Participants With Adverse Events (AEs)

    Timeframe: Up to 26 Weeks

  3. Number of Participants With Serious Adverse Events (SAEs)

    Timeframe: Up to 26 Weeks

  4. Number of Participants With Adverse Events of Special Interest (AESI)

    Timeframe: Up to 26 Weeks

    AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ

  5. Number of Participants With Vital Sign Abnormalities

    Timeframe: Up to 26 Weeks

    Defined as a graded abnormality in systolic blood pressure, diastolic blood pressure, pulse, respiratory rate, or oral temperature as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials at any time on/after receipt of study intervention.

  6. Number of Participants With Clinical Laboratory Abnormalities

    Timeframe: Up to 26 Weeks

    Defined as graded abnormality in chemistry, hematology, liver function, or urinalysis clinical laboratory values as per the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Trials at any time on/after receipt of study intervention.

  7. Number of Participants With Solicited Injection Site Reactions

    Timeframe: Up to Day 7 following study intervention administration

    Injection site reactions from the study intervention diary card

  8. Number of Participants With Solicited Systemic Reactions

    Timeframe: Up to Day 7 following study intervention administration

    Systemic reactions from the study intervention diary card

  1. Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])

    Timeframe: Up to 24 Weeks

    CDC-defined ILI with RT-PCR confirmed influenza A

  2. Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])

    Timeframe: Up to 24 Weeks

    WHO-defined ILI with RT-PCR confirmed influenza A

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
Yes

  • 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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Investigative SiteAnniston, United States
  • Investigative SiteMobile, United States
  • Investigative SiteTempe, United States
  • Investigative SiteLong Beach, United States
  • Investigative SitePomona, United States
  • Investigative SiteSan Diego, United States
  • Investigative SiteAurora, United States
  • Investigative SiteLongmont, United States
  • Investigative SiteFort Myers, United States
  • Investigative SiteJupiter, United States
  • Investigative SiteMiami, United States
  • Investigative SiteMiami, United States
  • Investigative SitePembroke Pines, United States
  • Investigative SiteWinter Park, United States
  • Investigative SiteLilburn, United States
  • Investigative SiteMeridian, United States
  • Investigative SiteChicago, United States
  • Investigative SiteSouth Bend, United States
  • Investigative SiteEl Dorado, United States
  • Investigative SiteLenexa, United States
  • Investigative SiteWichita, United States
  • Investigative SiteLexington, United States
  • Investigative SiteVersailles, United States
  • Investigative SiteMetairie, United States
  • Investigative SiteNew Orleans, United States

And 26 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)