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

Sponsor

Vir Biotechnology, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05567783

Collaborator

(none)

3,000

Enrollment

Locations

Arms

Anticipated Duration (Months)

58.8

Patients Per Site

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza A	Biological: VIR-2482 (dose 1) Biological: VIR-2482 (dose 2) Biological: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Oct 30, 2022

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VIR-2482 (Dose 1)	Biological: VIR-2482 (dose 1) VIR-2482 given by intramuscular injection
Experimental: VIR-2482 (Dose 2)	Biological: VIR-2482 (dose 2) VIR-2482 given by intramuscular injection
Placebo Comparator: Placebo	Biological: Placebo Sterile 0.9% (w/v) sodium chloride solution given by intramuscular injection

Arm

Intervention/Treatment

Experimental: VIR-2482 (Dose 1)

Biological: VIR-2482 (dose 1)

VIR-2482 given by intramuscular injection

Experimental: VIR-2482 (Dose 2)

Biological: VIR-2482 (dose 2)

VIR-2482 given by intramuscular injection

Placebo Comparator: Placebo

Biological: Placebo

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

Outcome Measures

Primary Outcome Measures

Proportion of participants with protocol-defined ILI with confirmed influenza A (by reverse transcription-polymerase chain reaction [RT-PCR]) [Up to Week 84]
Occurrence of adverse events (AEs) [Up to Week 84]
Occurrence of serious adverse events (SAEs) [Up to Week 84]
Occurrence of adverse events of special interest (AESI) [Up to Week 84]
Percentage of Participants with Abnormalities in Vital Signs [Up to Week 84]
Percentage of participants with abnormalities in vital signs (temperature, systolic blood pressure [SBP], diastolic blood pressure [DBP], pulse rate and respiratory rate) will be reported
Percentage of Participants with Clinically significant Abnormalities in Clinical Laboratory Tests [Up to Week 84]
Percentage of participants with abnormalities in clinical laboratory test (including hematology, Chemistry, Coagulation, and Urinalysis) will be reported

Secondary Outcome Measures

Proportion of participants with CDC-defined ILI with confirmed influenza A (by RT-PCR) [Up to Week 84]
Proportion of participants with WHO-defined ILI with confirmed influenza A (by RT-PCR) [Up to Week 84]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigative Site	Anniston	Alabama	United States	36207
2	Investigative Site	Mobile	Alabama	United States	36608
3	Investigative Site	Tempe	Arizona	United States	85281
4	Investigative Site	Long Beach	California	United States	90805
5	Investigative Site	Pomona	California	United States	91767
6	Investigative Site	San Diego	California	United States	92123
7	Investigative Site	Aurora	Colorado	United States	80918
8	Investigative Site	Longmont	Colorado	United States	80501
9	Investigative Site	Fort Myers	Florida	United States	33912
10	Investigative Site	Jupiter	Florida	United States	33458
11	Investigative Site	Miami	Florida	United States	33144
12	Investigative Site	Miami	Florida	United States	33165
13	Investigative Site	Pembroke Pines	Florida	United States	33024
14	Investigative Site	Winter Park	Florida	United States	32789
15	Investigative Site	Lilburn	Georgia	United States	30047
16	Investigative Site	Meridian	Idaho	United States	83642
17	Investigative Site	Chicago	Illinois	United States	60625
18	Investigative Site	South Bend	Indiana	United States	46617
19	Investigative Site	El Dorado	Kansas	United States	67042
20	Investigative Site	Lenexa	Kansas	United States	66219
21	Investigative Site	Wichita	Kansas	United States	67205
22	Investigative Site	Lexington	Kentucky	United States	40509
23	Investigative Site	Versailles	Kentucky	United States	40383
24	Investigative Site	Metairie	Louisiana	United States	70006
25	Investigative Site	New Orleans	Louisiana	United States	70115
26	Investigative Site	Methuen	Massachusetts	United States	01844
27	Investigative Site	Kansas City	Missouri	United States	64114
28	Investigative Site	Las Vegas	Nevada	United States	89030
29	Investigative Site	Las Vegas	Nevada	United States	89102
30	Investigative Site	Rochester	New York	United States	14618
31	Investigative Site	Monroe	North Carolina	United States	28112
32	Investigative Site	Raleigh	North Carolina	United States	27612
33	Investigative Site	Cincinnati	Ohio	United States	45242
34	Investigative Site	Edmond	Oklahoma	United States	73013
35	Investigative Site	Yukon	Oklahoma	United States	73099
36	Investigative Site	Anderson	South Carolina	United States	29621
37	Investigative Site	North Charleston	South Carolina	United States	29405
38	Investigative Site	Spartanburg	South Carolina	United States	29303
39	Investigative Site	Rapid City	South Dakota	United States	57702
40	Investigative Site	Elizabethton	Tennessee	United States	37643
41	Investigative Site	Knoxville	Tennessee	United States	37909
42	Investigative Site	Austin	Texas	United States	78705
43	Investigative Site	Austin	Texas	United States	78745
44	Investigative Site	Cedar Park	Texas	United States	78613
45	Investigative Site	Dallas	Texas	United States	75251
46	Investigative Site	Houston	Texas	United States	77055
47	Investigative Site	San Angelo	Texas	United States	76904
48	Investigative Site	San Antonio	Texas	United States	78229
49	Investigative Site	Tomball	Texas	United States	77375
50	Investigative Site	Layton	Utah	United States	84041
51	Investigative Site	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

Vir Biotechnology, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vir Biotechnology, Inc.

ClinicalTrials.gov Identifier:

NCT05567783

Other Study ID Numbers:

VIR-2482-4002

First Posted:

Oct 5, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vir Biotechnology, Inc.

Flu

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Dec 20, 2022