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TerminatedNCT05567783Updated Sep 19, 2024Results posted

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

A Phase 2 interventional study of VIR-2482 (450 mg) and VIR-2482 (1200 mg) in Influenza A, sponsored by Vir Biotechnology, Inc.. Terminated at 51 sites in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Vir Biotechnology, Inc. · Phase 2, Interventional, and Prevention

Why this study was terminated
VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint
Phase
Phase 2
Study type
Interventional
Enrollment
2,977
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza A

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Keywords

  • Flu
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 2,977 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Vir Biotechnology, Inc. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
2,977 participants (actual)

Study arms

  • Experimental
    VIR-2482 (Dose 1)

    Biological: VIR-2482 (450 mg)

  • Experimental
    VIR-2482 (Dose 2)

    Biological: VIR-2482 (1200 mg)

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalVIR-2482 (450 mg)

    VIR-2482 450mg given by intramuscular injection

  • BiologicalVIR-2482 (1200 mg)

    VIR-2482 1200 mg given by intramuscular injection

  • BiologicalPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 24 Weeks

  2. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 26 Weeks

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

    Time frame: Up to 26 Weeks

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

    AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ

    Time frame: Up to 26 Weeks

  5. 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.

    Time frame: Up to 26 Weeks

  6. 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.

    Time frame: Up to 26 Weeks

  7. Number of Participants With Solicited Injection Site Reactions

    Injection site reactions from the study intervention diary card

    Time frame: Up to Day 7 following study intervention administration

  8. Number of Participants With Solicited Systemic Reactions

    Systemic reactions from the study intervention diary card

    Time frame: Up to Day 7 following study intervention administration

Secondary outcomes

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

    CDC-defined ILI with RT-PCR confirmed influenza A

    Time frame: Up to 24 Weeks

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

    WHO-defined ILI with RT-PCR confirmed influenza A

    Time frame: Up to 24 Weeks

07

Results

Posted Sep 19, 2024

Participant flow

Participant flow — Overall Study
MilestoneVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Started989995993
Received study intervention981992983
Completed000
Not completed989995993
Withdrew: Death230
Withdrew: Lost to follow-up251917
Withdrew: Physician decision1079
Withdrew: Study terminated by sponsor924937941
Withdrew: Withdrawal by subject232724
Withdrew: Incarcerated100
Withdrew: Participant randomized in error422

Outcome measures

PrimaryPercentage 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

Time frame:
Up to 24 Weeks
Reported as:
Number · percentage of participants
Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
percentage of participantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])2.452.122.54
Statistical analysis
  • VIR-2482 (1200 mg) vs Placebo · Poisson regression · p = 0.5552 (two-sided, alpha=0.05) · Relative risk reduction (rrr, %): 15.85 · 95% CI -49.27 to 52.56RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group was the only factor in the model
  • VIR-2482 (450 mg) vs Placebo · Relative risk reduction (rrr, %): 3.78 · 95% CI -67.23 to 44.63RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.
PrimaryNumber of Participants With Adverse Events (AEs)
Time frame:
Up to 26 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs)
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Number of Participants With Adverse Events (AEs)636613639
PrimaryNumber of Participants With Serious Adverse Events (SAEs)
Time frame:
Up to 26 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs)
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Number of Participants With Serious Adverse Events (SAEs)10139
PrimaryNumber of Participants With Adverse Events of Special Interest (AESI)

AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ

Time frame:
Up to 26 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest (AESI)
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Number of Participants With Adverse Events of Special Interest (AESI)000
PrimaryNumber 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.

Time frame:
Up to 26 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Vital Sign Abnormalities
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Number of Participants With Vital Sign Abnormalities678662648
PrimaryNumber 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.

Time frame:
Up to 26 Weeks
Reported as:
Count of participants · Participants
Number of Participants With Clinical Laboratory Abnormalities
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Number of Participants With Clinical Laboratory Abnormalities961971961
PrimaryNumber of Participants With Solicited Injection Site Reactions

Injection site reactions from the study intervention diary card

Time frame:
Up to Day 7 following study intervention administration
Reported as:
Count of participants · Participants
Number of Participants With Solicited Injection Site Reactions
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Any injection site reaction292293272
Pain279277260
Erythema7105
Induration8123
Swelling10132
Bruising172021
PrimaryNumber of Participants With Solicited Systemic Reactions

Systemic reactions from the study intervention diary card

Time frame:
Up to Day 7 following study intervention administration
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic Reactions
ParticipantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Any systemic reaction265283268
Headache160168175
Myalgia135169149
Malaise117130123
Shivering446043
Fever111113
SecondaryPercentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])

CDC-defined ILI with RT-PCR confirmed influenza A

Time frame:
Up to 24 Weeks
Reported as:
Number · percentage of participants
Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
percentage of participantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])1.530.711.73
Statistical analysis
  • VIR-2482 (1200 mg) · Relative risk reduction (rrr, %): 57.23 · 95% CI -2.51 to 82.15RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.
  • VIR-2482 (450 mg) vs Placebo · Relative risk reduction (rrr, %): 11.45 · 95% CI -76.25 to 55.51RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.
SecondaryPercentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])

WHO-defined ILI with RT-PCR confirmed influenza A

Time frame:
Up to 24 Weeks
Reported as:
Number · percentage of participants
Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
percentage of participantsVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Percentage of Participants With WHO-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])1.220.61.12
Statistical analysis
  • VIR-2482 (1200 mg) vs Placebo · Relative risk reduction (rrr, %): 44.13 · 95% CI -50.49 to 79.26RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95%CI are nominal and not adjusted for multiple comparisons.
  • VIR-2482 (450 mg) vs Placebo · Relative risk reduction (rrr, %): -9.80 · 95% CI -147.41 to 51.27RRR and 95% CI estimated using Poisson regression of multiple imputed data with treatment group the only factor in the model; 95% CI are nominal and not adjusted for multiple comparisons.

Adverse events

Collected over through study completion for each participant, up to approximately 43 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
VIR-2482 (450 mg)2/981 (0.2%)10/981 (1%)454/981 (46.3%)
VIR-2482 (1200 mg)3/992 (0.3%)13/992 (1.3%)450/992 (45.4%)
Placebo0/983 (0%)9/983 (0.9%)460/983 (46.8%)
Most frequent serious events
Showing 10 of 42
Most frequent serious events
EventVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Abortion spontaneousPregnancy, puerperium and perinatal conditions2/9810/9920/983
DehydrationMetabolism and nutrition disorders0/9810/9922/983
CellulitisInfections and infestations1/9810/9920/983
Urinary tract infectionInfections and infestations1/9810/9920/983
Accidental overdoseInjury, poisoning and procedural complications1/9810/9920/983
Traumatic fractureInjury, poisoning and procedural complications1/9810/9920/983
Acute psychosisPsychiatric disorders1/9810/9920/983
Completed suicidePsychiatric disorders1/9810/9920/983
Conversion disorderPsychiatric disorders1/9810/9920/983
Major depressionPsychiatric disorders1/9810/9920/983
Most frequent other events
Most frequent other events
EventVIR-2482 (450 mg)VIR-2482 (1200 mg)Placebo
Upper respiratory tract infectionInfections and infestations243/981245/992248/983
COVID-19Infections and infestations93/98191/992106/983
Oropharyngeal painRespiratory, thoracic and mediastinal disorders95/98187/99275/983
CoughRespiratory, thoracic and mediastinal disorders88/98184/99272/983
Viral infectionInfections and infestations56/98148/99270/983
MyalgiaMusculoskeletal and connective tissue disorders51/98136/99238/983

Baseline characteristics

All participants who received any amount of study intervention.

Age, Continuous
Age, Continuous(Years)VIR-2482 (450 mg)VIR-2482 (1200 mg)PlaceboTotal
Mean39.2 ± 12.5239.6 ± 11.7339.7 ± 12.2939.5 ± 12.18
Sex: Female, Male
Sex: Female, Male(Participants)VIR-2482 (450 mg)VIR-2482 (1200 mg)PlaceboTotal
Female5455235301598
Male4364694531358
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)VIR-2482 (450 mg)VIR-2482 (1200 mg)PlaceboTotal
Hispanic or Latino3713693571097
Not Hispanic or Latino6066226201848
Unknown or Not Reported41611
Race (NIH/OMB)
Race (NIH/OMB)(Participants)VIR-2482 (450 mg)VIR-2482 (1200 mg)PlaceboTotal
American Indian or Alaska Native77721
Asian26292681
Native Hawaiian or Other Pacific Islander54413
Black or African American154176166496
White7527477582257
More than one race1711634
Unknown or Not Reported20181654
Region of Enrollment
Region of Enrollment(participants)VIR-2482 (450 mg)VIR-2482 (1200 mg)PlaceboTotal
United States9819929832956
Body Mass Index
Body Mass Index(kg/m^2)VIR-2482 (450 mg)VIR-2482 (1200 mg)PlaceboTotal
Mean27.34 ± 4.08527.44 ± 4.16727.4 ± 4.07127.34 ± 4.107
08

Study locations

51 sites
  • Investigative Site
    Anniston, Alabama 36207, United States
  • Investigative Site
    Mobile, Alabama 36608, United States
  • Investigative Site
    Tempe, Arizona 85281, United States
  • Investigative Site
    Long Beach, California 90805, United States
  • Investigative Site
    Pomona, California 91767, United States
  • Investigative Site
    San Diego, California 92123, United States
  • Investigative Site
    Aurora, Colorado 80918, United States
  • Investigative Site
    Longmont, Colorado 80501, United States
  • Investigative Site
    Fort Myers, Florida 33912, United States
  • Investigative Site
    Jupiter, Florida 33458, United States
  • Investigative Site
    Miami, Florida 33144, United States
  • Investigative Site
    Miami, Florida 33165, United States
  • Investigative Site
    Pembroke Pines, Florida 33024, United States
  • Investigative Site
    Winter Park, Florida 32789, United States
  • Investigative Site
    Lilburn, Georgia 30047, United States
  • Investigative Site
    Meridian, Idaho 83642, United States
  • Investigative Site
    Chicago, Illinois 60625, United States
  • Investigative Site
    South Bend, Indiana 46617, United States
  • Investigative Site
    El Dorado, Kansas 67042, United States
  • Investigative Site
    Lenexa, Kansas 66219, United States
  • Investigative Site
    Wichita, Kansas 67205, United States
  • Investigative Site
    Lexington, Kentucky 40509, United States
  • Investigative Site
    Versailles, Kentucky 40383, United States
  • Investigative Site
    Metairie, Louisiana 70006, United States
  • Investigative Site
    New Orleans, Louisiana 70115, United States
  • Investigative Site
    Methuen, Massachusetts 01844, United States
  • Investigative Site
    Kansas City, Missouri 64114, United States
  • Investigative Site
    Las Vegas, Nevada 89030, United States
  • Investigative Site
    Las Vegas, Nevada 89102, United States
  • Investigative Site
    Rochester, New York 14618, United States
  • Investigative Site
    Monroe, North Carolina 28112, United States
  • Investigative Site
    Raleigh, North Carolina 27612, United States
  • Investigative Site
    Cincinnati, Ohio 45242, United States
  • Investigative Site
    Edmond, Oklahoma 73013, United States
  • Investigative Site
    Yukon, Oklahoma 73099, United States
  • Investigative Site
    Anderson, South Carolina 29621, United States
  • Investigative Site
    North Charleston, South Carolina 29405, United States
  • Investigative Site
    Spartanburg, South Carolina 29303, United States
  • Investigative Site
    Rapid City, South Dakota 57702, United States
  • Investigative Site
    Elizabethton, Tennessee 37643, United States
  • Investigative Site
    Knoxville, Tennessee 37909, United States
  • Investigative Site
    Austin, Texas 78705, United States
  • Investigative Site
    Austin, Texas 78745, United States
  • Investigative Site
    Cedar Park, Texas 78613, United States
  • Investigative Site
    Dallas, Texas 75251, United States
  • Investigative Site
    Houston, Texas 77055, United States
  • Investigative Site
    San Angelo, Texas 76904, United States
  • Investigative Site
    San Antonio, Texas 78229, United States
  • Investigative Site
    Tomball, Texas 77375, United States
  • Investigative Site
    Layton, Utah 84041, United States
  • Investigative Site
    Norfolk, Virginia 23502, United States
09

References and documents

Study documents

  • Study protocol · Jun 29, 2023
  • Statistical analysis plan · Jun 13, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05567783
Lead sponsor
Vir Biotechnology, Inc.
Responsible party
Sponsor
First posted
Oct 5, 2022
Start date
Oct 30, 2022
Primary completion
May 5, 2023
Completion
Aug 31, 2023
Results posted
Sep 19, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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