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

Phase 2

Terminated

• Conditions: Influenza A
• Interventions: Biological: VIR-2482 (450 mg); Biological: VIR-2482 (1200 mg); Biological: Placebo

• Registration Number: NCT05567783
• Lead Sponsor: Vir Biotechnology, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-24
• Study First Submitted QC: 2022-09-30
• Study First Posted: 2022-10-05
• Study Start: 2022-10-30
• Primary Completion: 2023-05-05
• Study Completion: 2023-08-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2985

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIR-2482 (Dose 1)	VIR-2482 (450 mg)	-
VIR-2482 (Dose 2)	VIR-2482 (1200 mg)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Protocol-defined Influenza-like Illness (ILI) With Confirmed Influenza A (by Reverse Transcription Polymerase Chain Reaction [RT-PCR])	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)	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)	Up to 26 Weeks	AESI is anaphylaxis per MedDRA anaphylaxis algorithmic SMQ
Number of Participants With Vital Sign Abnormalities	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	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	Up to Day 7 following study intervention administration	Injection site reactions from the study intervention diary card
Number of Participants With Solicited Systemic Reactions	Up to Day 7 following study intervention administration	Systemic reactions from the study intervention diary card

Secondary Outcome Measures

Name	Time	Method
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	CDC-defined ILI with RT-PCR confirmed influenza A
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	WHO-defined ILI with RT-PCR confirmed influenza A

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Norfolk, Virginia, United States