VIR-2482 for Flu Prevention

No longer recruiting at 47 trial locations

Overseen By Study Inquiry

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Vir Biotechnology, Inc.

Disqualifiers: High-risk conditions, Recent influenza, Malignancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, VIR-2482, to determine its effectiveness in preventing influenza A in healthy adults. Researchers aim to assess the safety and efficacy of VIR-2482 compared to a placebo, a substance with no active medicine. Participants who are generally healthy and have not recently had the flu may be suitable for this study. The trial includes different groups, with some receiving varying doses of VIR-2482 and others receiving a placebo. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that VIR-2482 is likely to be safe for humans?

Research shows that VIR-2482 is generally safe and well tolerated in people. In earlier studies, healthy participants received single doses up to 1800 mg. These studies found that VIR-2482 was well tolerated with no major safety issues. Another study confirmed that VIR-2482, when given by injection, was safe at similar doses. No significant safety concerns arose, meaning no unexpected problems occurred. So far, the evidence suggests that VIR-2482 is safe for use in these trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for influenza A, like antivirals such as oseltamivir, work by inhibiting the virus from replicating. But VIR-2482 is different because it uses a monoclonal antibody designed to provide direct and immediate protection against the influenza A virus. This approach could offer a unique advantage by preventing illness before it starts, rather than treating it after infection. Researchers are excited because this could potentially lead to a faster, more effective prevention strategy compared to traditional antiviral medications.

What evidence suggests that VIR-2482 might be an effective treatment for influenza A?

This trial will evaluate VIR-2482 at two different doses to help prevent influenza A. Studies have shown that VIR-2482 can reduce the risk of influenza A. Specifically, research indicates that at the highest dose, participants had about a 57% lower chance of developing symptoms of influenza A. This suggests that VIR-2482 could significantly reduce the risk of catching this type of flu. Early findings also show that VIR-2482 is generally well-tolerated, with most participants not experiencing serious side effects. While more information is needed, these results are promising for those seeking to avoid influenza A. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

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

You have taken any experimental medication within the last 90 days or within 5 half-lives of that medication.

History of confirmed influenza infection within 3 months prior to randomization.

You have a medical history or symptoms that put you at a high risk of developing complications from the flu.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive VIR-2482 or placebo to evaluate efficacy, safety, and tolerability in preventing influenza A

Up to 26 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and laboratory abnormalities

Up to 26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• VIR-2482

How Is the Trial Designed?

Group I: VIR-2482 (Dose 2) Experimental Treatment 1 Intervention

Group II: VIR-2482 (Dose 1) Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Vir Biotechnology, Inc.

Lead Sponsor

Trials

30

Recruited

13,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39036981/

A Randomized, Placebo-Controlled Trial to Evaluate the ... Results: VIR-2482 450 mg and 1200 mg prophylaxis did not reduce the risk of protocol-defined ILI with reverse transcriptase-polymerase chain ...

2. academic.oup.com academic.oup.com/cid/article/79/4/1054/7717845

Randomized, Placebo-Controlled Trial to Evaluate the Safety ... A sample size of approximately 3000 participants was needed to provide approximately 80% power to detect VIR-2482 efficacy (a true relative risk reduction [RRR ...

3. investors.vir.bio investors.vir.bio/news/news-details/2023/Vir-Biotechnology-Announces-Topline-Data-from-Phase-2-PENINSULA-Trial-Evaluating-VIR-2482-for-the-Prevention-of-Seasonal-Influenza-A-Illness-07-20-2023/default.aspx

Vir Biotechnology Announces Topline Data from Phase 2 ... Participants who received the highest dose showed an approximately 57% reduction in symptomatic influenza A illness, when defined according to ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05567783

NCT05567783 | A Phase 2 Study to Evaluate the Efficacy ... 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 ...

5. journals.asm.org journals.asm.org/doi/10.1128/aac.01273-23

A phase 1 study in healthy volunteers to investigate the safety ... VIR-2482 was well tolerated at all doses studied. The overall incidence of AEs was comparable between VIR-2482 (68.8%) and placebo (85.0%). Nineteen VIR-2482 ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7776649/

631. Preliminary safety and pharmacokinetic profile of VIR ... Based on available data, VIR-2482 has been well tolerated following single IM doses of up to 1800 mg in healthy subjects. The preliminary PK profile of VIR-2482 ...