Influenza APhase 2NCT05567783

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 study testing VIR-2482 (450 mg) and VIR-2482 (1200 mg) in people with Influenza A, run by Vir Biotechnology, Inc. at 51 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Influenza A
What is being tested?: VIR-2482 (450 mg) and VIR-2482 (1200 mg)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,977 participants
Where: 51 sitesUnited States
Study dates: 30 Oct 2022to 31 Aug 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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.

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

United States51 sites

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

Other trials in United States

About this study

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

Conditions: Influenza A
Being tested: VIR-2482 (450 mg), VIR-2482 (1200 mg), Placebo
Keywords: Flu
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VIR-2482 (450 mg)Biological
VIR-2482 450mg given by intramuscular injection
VIR-2482 (1200 mg)Biological
VIR-2482 1200 mg given by intramuscular injection
PlaceboBiological
Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection

Study groups in NCT05567783
Study group	Role	What they receive
VIR-2482 (Dose 1)	Experimental	Not described Receives: Biological: VIR-2482 (450 mg)
VIR-2482 (Dose 2)	Experimental	Not described Receives: Biological: VIR-2482 (1200 mg)
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to 24 Weeks
Number of Participants With Adverse Events (AEs)
Measured: Up to 26 Weeks
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to 26 Weeks
Number of Participants With Adverse Events of Special Interest (AESI)
AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ
Measured: 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.
Measured: 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.
Measured: Up to 26 Weeks
Number of Participants With Solicited Injection Site Reactions
Injection site reactions from the study intervention diary card
Measured: Up to Day 7 following study intervention administration
Number of Participants With Solicited Systemic Reactions
Systemic reactions from the study intervention diary card
Measured: 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])
CDC-defined ILI with RT-PCR confirmed influenza A
Measured: 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])
WHO-defined ILI with RT-PCR confirmed influenza A
Measured: Up to 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 202231 Aug 2023

First posted5 Oct 2022
Study start30 Oct 2022
Primary completion5 May 2023
Study completion31 Aug 2023

Why it stopped: VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Influenza AStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,977 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05567783
Sponsor's protocol ID: VIR-2482-4002
Status last verified: May 2024
First submitted: 24 Sep 2022
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

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.
PubMed 39036981

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza A trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05567783
Acronym / sponsor ID: VIR-2482-4002
Conditions: Influenza A
Keywords: Flu
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: VIR-2482 1200 mg did not demonstrate efficacy versus placebo in the primary analysis of the primary endpoint
Enrolment: 2,977 participants (actual)
Lead sponsor: Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
Study start: 30 Oct 2022 (actual)
Primary completion: 5 May 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 5 Oct 2022 (actual)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VIR-2482 (450 mg)VIR-2482 450mg given by intramuscular injection	Biological	VIR-2482 (Dose 1)
VIR-2482 (1200 mg)VIR-2482 1200 mg given by intramuscular injection	Biological	VIR-2482 (Dose 2)
PlaceboSterile 0.9% (w/v) sodium chloride solution given by intramuscular injection	Biological	Placebo

Primary outcome

Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
Time frame: 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
Number of Participants With Adverse Events (AEs)
Time frame: Up to 26 Weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to 26 Weeks
Number of Participants With Adverse Events of Special Interest (AESI)
Time frame: Up to 26 Weeks
AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ
Number of Participants With Vital Sign Abnormalities
Time frame: 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.
Number of Participants With Clinical Laboratory Abnormalities
Time frame: 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.
Number of Participants With Solicited Injection Site Reactions
Time frame: Up to Day 7 following study intervention administration
Injection site reactions from the study intervention diary card
Number of Participants With Solicited Systemic Reactions
Time frame: Up to Day 7 following study intervention administration
Systemic reactions from the study intervention diary card

2 secondary outcomes

Percentage of Participants With CDC-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])
Time frame: 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])
Time frame: Up to 24 Weeks

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VIR-2482 (450 mg)	989	0
VIR-2482 (1200 mg)	995	0
Placebo	993	0

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

Time frame: Up to 24 Weeks. Number. Unit: percentage of participants

Measure	VIR-2482 (450 mg) n = 981	VIR-2482 (1200 mg) n = 992	Placebo n = 983
Value	2.45	2.12	2.54

VIR-2482 (1200 mg) vs Placebo: Relative risk reduction (RRR, %): 15.85 (95% CI -49.27 to 52.56), p = 0.5552, Poisson regression
VIR-2482 (450 mg) vs Placebo: Relative risk reduction (RRR, %): 3.78 (95% CI -67.23 to 44.63)

Population analysed: Full Analysis Set (all randomized who did not have confirmed influenza infection within 3 months prior to randomization, did not receive an influenza vaccination for the upcoming influenza season, and received any amount of study intervention). Participants were analyzed according to the randomized study intervention.

Primary outcome: Number of Participants With Adverse Events (AEs)

Time frame: Up to 26 Weeks. Count of participants. Unit: Participants

Measure	VIR-2482 (450 mg) n = 981	VIR-2482 (1200 mg) n = 992	Placebo n = 983
Value	636	613	639

Population analysed: Participants who received any amount of study intervention. Participants were analyzed according to study intervention received.

Primary outcome: Number of Participants With Serious Adverse Events (SAEs)

Time frame: Up to 26 Weeks. Count of participants. Unit: Participants

Measure	VIR-2482 (450 mg) n = 981	VIR-2482 (1200 mg) n = 992	Placebo n = 983
Value	10	13	9

Population analysed: Participants who received any amount of study intervention. Participants were analyzed according to the study intervention received.

Primary outcome: Number of Participants With Adverse Events of Special Interest (AESI)

Time frame: Up to 26 Weeks. Count of participants. Unit: Participants

Measure	VIR-2482 (450 mg) n = 981	VIR-2482 (1200 mg) n = 992	Placebo n = 983
Value	0	0	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: through study completion for each participant, up to approximately 43 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VIR-2482 (450 mg)	10 of 981 (1%)	454 of 981 (46.3%)	2 of 981
VIR-2482 (1200 mg)	13 of 992 (1.3%)	450 of 992 (45.4%)	3 of 992
Placebo	9 of 983 (0.9%)	460 of 983 (46.8%)	0 of 983

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39036981Tan 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.
Individual participant dataSharing planned: Yes

Related trials for Influenza A

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VIR-2482 (450 mg) and VIR-2482 (1200 mg) in people with Influenza A, run by Vir Biotechnology, Inc. at 51 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR]) (time frame: Up to 24 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05567783, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.