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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04033406




Registration number
NCT04033406
Ethics application status
Date submitted
22/07/2019
Date registered
26/07/2019
Date last updated
1/06/2020

Titles & IDs
Public title
Study of VIR-2482 in Healthy Volunteers
Scientific title
A Phase 1/2, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity, and Efficacy of VIR-2482 for the Prevention of Influenza A Illness
Secondary ID [1] 0 0
VIR-2482-3001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - VIR-2482
Treatment: Drugs - Placebo

Experimental: VIR-2482 - VIR-2482

Placebo Comparator: Placebo - Placebo


Treatment: Drugs: VIR-2482
VIR-2482 given by intramuscular injection

Treatment: Drugs: Placebo
Sterile normal saline (0.9% NaCl) given by intramuscular injection

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-emergent adverse events.
Timepoint [1] 0 0
Up to 8 months post-dose
Primary outcome [2] 0 0
Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings.
Timepoint [2] 0 0
Up to 8 months post-dose
Primary outcome [3] 0 0
Number of participants with laboratory-confirmed influenza A illness.
Timepoint [3] 0 0
Up to 8 months post-dose
Secondary outcome [1] 0 0
Number of participants with culture-confirmed influenza A illness
Timepoint [1] 0 0
Up to 8 months post-dose
Secondary outcome [2] 0 0
Severity and duration of participant-reported signs and symptoms of influenza like illness (ILI) due to influenza A
Timepoint [2] 0 0
Up to 8 months post-dose
Secondary outcome [3] 0 0
Quantification of the viral load present in nasopharyngeal secretions at the time of initial symptomatic presentation by RT-qPCR and viral culture
Timepoint [3] 0 0
Up to 8 months post-dose
Secondary outcome [4] 0 0
Concentrations of VIR-2482 in serum
Timepoint [4] 0 0
Up to 8 months post-dose
Secondary outcome [5] 0 0
Incidence and titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Timepoint [5] 0 0
Up to 8 months post-dose

Eligibility
Key inclusion criteria
- Healthy Male or Female age 18 to < 65 years

- Body mass index (BMI) of 18.0 kg/m^2 to 35.0kg/m^2
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any prior or planned influenza vaccination for the upcoming flu season

- Any clinically significant chronic or acute medical condition that makes the volunteer
unsuitable for participation

- History of influenza-like illness or confirmed influenza infection within 3 months
prior to randomization.

- Fever-like illness within 5 days of randomization.

- History or clinical evidence of conditions considered high risk for developing
influenza-related complications.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Investigative Site - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase 1/2 study in which healthy volunteers will receive VIR-2482 or placebo and
will be assessed for safety, pharmacokinetics, immunogenicity, and efficacy of VIR-2482 in
preventing Influenza A illness.
Trial website
https://clinicaltrials.gov/show/NCT04033406
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications