Clinical trial NCT05567783: A Phase 2 Study to Evaluate the Efficacy and Safety of VIR-2482 for the Prevention of Illness Due to Influenza A
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Influenza A
Keywords: Flu
Lead sponsor: Vir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-05
Enrollment: 2977
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 26 Weeks
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 26 Weeks
measure: Number of Participants With Adverse Events of Special Interest (AESI)
timeFrame: Up to 26 Weeks
measure: Number of Participants With Vital Sign Abnormalities
timeFrame: Up to 26 Weeks
measure: Number of Participants With Clinical Laboratory Abnormalities
timeFrame: Up to 26 Weeks
measure: Number of Participants With Solicited Injection Site Reactions
timeFrame: Up to Day 7 following study intervention administration
measure: Number of Participants With Solicited Systemic Reactions
timeFrame: Up to Day 7 following study intervention administration
Secondary outcomes:
measure: 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
measure: 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
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Investigative Site
state: Alabama
city: Mobile
country: United States
facility: Investigative Site
state: Alabama
city: Tempe
country: United States
facility: Investigative Site
state: Arizona
city: Long Beach
country: United States
facility: Investigative Site
state: California
city: Pomona
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Aurora
country: United States
facility: Investigative Site
state: Colorado
city: Longmont
country: United States
facility: Investigative Site
state: Colorado
city: Fort Myers
country: United States
facility: Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Pembroke Pines
country: United States
facility: Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Investigative Site
state: Florida
city: Lilburn
country: United States
facility: Investigative Site
state: Georgia
city: Meridian
country: United States
facility: Investigative Site
state: Idaho
city: Chicago
country: United States
facility: Investigative Site
state: Illinois
city: South Bend
country: United States
facility: Investigative Site
state: Indiana
city: El Dorado
country: United States
facility: Investigative Site
state: Kansas
city: Lenexa
country: United States
facility: Investigative Site
state: Kansas
city: Wichita
country: United States
facility: Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Investigative Site
state: Kentucky
city: Versailles
country: United States
facility: Investigative Site
state: Kentucky
city: Metairie
country: United States
facility: Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Investigative Site
state: Louisiana
city: Methuen
country: United States
facility: Investigative Site
state: Massachusetts
city: Kansas City
country: United States
facility: Investigative Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Rochester
country: United States
facility: Investigative Site
state: New York
city: Monroe
country: United States
facility: Investigative Site
state: North Carolina
city: Raleigh
country: United States
facility: Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Edmond
country: United States
facility: Investigative Site
state: Oklahoma
city: Yukon
country: United States
facility: Investigative Site
state: Oklahoma
city: Anderson
country: United States
facility: Investigative Site
state: South Carolina
city: North Charleston
country: United States
facility: Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Investigative Site
state: South Carolina
city: Rapid City
country: United States
facility: Investigative Site
state: South Dakota
city: Elizabethton
country: United States
facility: Investigative Site
state: Tennessee
city: Knoxville
country: United States
facility: Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Austin
country: United States
facility: Investigative Site
state: Texas
city: Cedar Park
country: United States
facility: Investigative Site
state: Texas
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: San Angelo
country: United States
facility: Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Investigative Site
state: Texas
city: Tomball
country: United States
facility: Investigative Site
state: Texas
city: Layton
country: United States
facility: Investigative Site
state: Utah
city: Norfolk
country: United States
facility: Investigative Site
state: Virginia
Study officials:
References: