Influenza APhase 1NCT04033406
Study of VIR-2482 in Healthy Volunteers
A Phase 1 study testing VIR-2482 in people with Influenza A, run by Vir Biotechnology, Inc. at 1 site in Australia.
Trial summary
This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2019to 1 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy Male or Female age 18 to < 65 years
- Body mass index (BMI) of 18.0 kg/m^2 to 32.0kg/m^2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness
This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.
- Conditions
- Influenza A
- Being tested
- VIR-2482, Placebo
- Keywords
- Influenza A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIR-2482Drug
VIR-2482 given by intramuscular injection
PlaceboDrug
Sterile normal saline (0.9% NaCl) given by intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| VIR-2482 | Experimental | VIR-2482 Receives: Drug: VIR-2482 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events.
Measured: Up to 12 months post-dose
Number of participants with abnormalities in vital signs.
Measured: Up to 12 months post-dose
Number of participants with abnormalities in electrocardiogram (ECG).
Measured: Up to 12 months post-dose
Number of participants with abnormalities in clinically significant laboratory findings.
Measured: Up to 12 months post-dose
Secondary outcomes (3)
Concentrations of VIR-2482 in serum
Measured: Up to 12 months post-dose
Incidence of anti-drug antibody (ADA) to VIR-2482
Measured: Up to 12 months post-dose
Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Measured: Up to 12 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start26 Aug 2019
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033406
- Sponsor's protocol ID
- VIR-2482-3001
- Status last verified
- Jun 2022
- First submitted
- 22 Jul 2019
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Plotnik D, Sager JE, Aryal M, Fanget MC, Peter A, Schmid MA, Cebrik D, Mogalian E, Boundy K, Yeh WW, Griffin P, Reyes M. A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness. Antimicrob Agents Chemother. 2024 Apr 3;68(4):e0127323. doi: 10.1128/aac.01273-23. Epub 2024 Feb 20.
PubMed 38376227
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness
- ClinicalTrials.gov ID
- NCT04033406
- Acronym / sponsor ID
- VIR-2482-3001
- Conditions
- Influenza A
- Keywords
- Influenza A
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Vir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VIR-2482 | Experimental | Drug: VIR-2482VIR-2482 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Male or Female age 18 to < 65 years
- Body mass index (BMI) of 18.0 kg/m^2 to 32.0kg/m^2
Key exclusion criteria (4 listed)
- 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.
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-2482VIR-2482 given by intramuscular injection | Drug | VIR-2482 |
| PlaceboSterile normal saline (0.9% NaCl) given by intramuscular injection | Drug | Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events.
Time frame: Up to 12 months post-dose
Number of participants with abnormalities in vital signs.
Time frame: Up to 12 months post-dose
Number of participants with abnormalities in electrocardiogram (ECG).
Time frame: Up to 12 months post-dose
Number of participants with abnormalities in clinically significant laboratory findings.
Time frame: Up to 12 months post-dose
3 secondary outcomes
Concentrations of VIR-2482 in serum
Time frame: Up to 12 months post-dose
Incidence of anti-drug antibody (ADA) to VIR-2482
Time frame: Up to 12 months post-dose
Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482
Time frame: Up to 12 months post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 38376227Plotnik D, Sager JE, Aryal M, Fanget MC, Peter A, Schmid MA, Cebrik D, Mogalian E, Boundy K, Yeh WW, Griffin P, Reyes M. A phase 1 study in healthy volunteers to investigate the safety, tolerability, and pharmacokinetics of VIR-2482: a monoclonal antibody for the prevention of severe influenza A illness. Antimicrob Agents Chemother. 2024 Apr 3;68(4):e0127323. doi: 10.1128/aac.01273-23. Epub 2024 Feb 20.
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Healthy Participants
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIR-2482 in people with Influenza A, run by Vir Biotechnology, Inc. at 1 site in Australia.
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 4 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: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-emergent adverse events. (time frame: Up to 12 months post-dose). The study lists 4 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 NCT04033406, 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 9 Jun 2022.