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

NCT05567783 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: VIR-2482-4002
• Study Type: interventional
• Target: 2,977
• Locations: 1 country
• Sites: 51

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.

Conditions

Influenza A

Keywords

Flu

Outcome Measures

Primary Outcomes (8)

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

  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

  Up to 24 Weeks

• Number of Participants With Adverse Events (AEs)

  Up to 26 Weeks

• Number of Participants With Serious Adverse Events (SAEs)

  Up to 26 Weeks

• Number of Participants With Adverse Events of Special Interest (AESI)

  AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ

  Up to 26 Weeks

• Number of Participants With Vital Sign Abnormalities

  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.

  Up to 26 Weeks

• Number of Participants With Clinical Laboratory Abnormalities

  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.

  Up to 26 Weeks

• Number of Participants With Solicited Injection Site Reactions

  Injection site reactions from the study intervention diary card

  Up to Day 7 following study intervention administration

• Number of Participants With Solicited Systemic Reactions

  Systemic reactions from the study intervention diary card

  Up to Day 7 following study intervention administration

Secondary Outcomes (2)

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

  Up to 24 Weeks

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

  Up to 24 Weeks

Study Arms (3)

VIR-2482 (Dose 1)

EXPERIMENTAL

Biological: VIR-2482 (450 mg)

VIR-2482 (Dose 2)

EXPERIMENTAL

Biological: VIR-2482 (1200 mg)

Placebo

PLACEBO COMPARATOR

Biological: Placebo

Interventions

VIR-2482 (450 mg) BIOLOGICAL

VIR-2482 450mg given by intramuscular injection

VIR-2482 (Dose 1)

VIR-2482 (1200 mg) BIOLOGICAL

VIR-2482 1200 mg given by intramuscular injection

VIR-2482 (Dose 2)

Placebo BIOLOGICAL

Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vir Biotechnology, Inc.: lead

Study Sites (51)

Investigative Site

Anniston, Alabama, 36207, United States

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Mobile, Alabama, 36608, United States

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Tempe, Arizona, 85281, United States

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Long Beach, California, 90805, United States

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Pomona, California, 91767, United States

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San Diego, California, 92123, United States

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Aurora, Colorado, 80918, United States

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Longmont, Colorado, 80501, United States

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Fort Myers, Florida, 33912, United States

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Jupiter, Florida, 33458, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33165, United States

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Pembroke Pines, Florida, 33024, United States

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Winter Park, Florida, 32789, United States

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Lilburn, Georgia, 30047, United States

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Meridian, Idaho, 83642, United States

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Chicago, Illinois, 60625, United States

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South Bend, Indiana, 46617, United States

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El Dorado, Kansas, 67042, United States

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Lenexa, Kansas, 66219, United States

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Wichita, Kansas, 67205, United States

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Lexington, Kentucky, 40509, United States

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Versailles, Kentucky, 40383, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70115, United States

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Methuen, Massachusetts, 01844, United States

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Kansas City, Missouri, 64114, United States

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Las Vegas, Nevada, 89030, United States

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Las Vegas, Nevada, 89102, United States

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Rochester, New York, 14618, United States

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Monroe, North Carolina, 28112, United States

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Raleigh, North Carolina, 27612, United States

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Cincinnati, Ohio, 45242, United States

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Edmond, Oklahoma, 73013, United States

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Yukon, Oklahoma, 73099, United States

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Anderson, South Carolina, 29621, United States

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North Charleston, South Carolina, 29405, United States

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Spartanburg, South Carolina, 29303, United States

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Rapid City, South Dakota, 57702, United States

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Elizabethton, Tennessee, 37643, United States

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Knoxville, Tennessee, 37909, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78745, United States

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Cedar Park, Texas, 78613, United States

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Dallas, Texas, 75251, United States

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Houston, Texas, 77055, United States

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San Angelo, Texas, 76904, United States

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San Antonio, Texas, 78229, United States

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Tomball, Texas, 77375, United States

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Layton, Utah, 84041, United States

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Investigative Site

Norfolk, Virginia, 23502, United States

Location

Related Publications (1)

• Tan SK, Cebrik D, Plotnik D, Agostini ML, Boundy K, Hebner CM, Yeh WW, Pang PS, Moya J, Fogarty C, Darani M, Hayden FG. A Randomized, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of VIR-2482 in Healthy Adults for Prevention of Influenza A Illness (PENINSULA). Clin Infect Dis. 2024 Oct 15;79(4):1054-1061. doi: 10.1093/cid/ciae368.

  PMID: 39036981 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Study Inquiry
• Organization: Vir Biotechnology, Inc.

clinicaltrials@vir.bio

415-654-5281

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2022
• First Posted: October 5, 2022
• Study Start: October 30, 2022
• Primary Completion: May 5, 2023
• Study Completion: August 31, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (51)