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

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

2977 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing VIR-2482, a new treatment aimed at preventing the flu (influenza A). It focuses on healthy adults aged 18 to less than 65 years who do not have risk factors for serious flu complications. The treatment likely works by boosting the immune system or directly fighting the flu virus.

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 the treatment generally safe for humans?

Maraviroc, a CCR5 antagonist similar to VIR-2482, has shown a very favorable safety profile in clinical trials, with no significant increase in liver toxicity, serious infections, or neoplasms (tumors). ^{1 2 3 4 5}

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. England pubmed.ncbi.nlm.nih.gov

Vicriviroc plus optimized background therapy for treatment-experienced subjects with CCR5 HIV-1 infection: final results of two randomized phase III trials. [2012]

2. France pubmed.ncbi.nlm.nih.gov

Specific reactions between purified HIV-1 particles and CD4+ cell membrane fragments in a cell-free system of virus fusion or entry. [2017]

3. France pubmed.ncbi.nlm.nih.gov

[CCR5 antagonists: a new class of antiretrovirals]. [2014]

4. England pubmed.ncbi.nlm.nih.gov

Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial. [2020]

5. Spain pubmed.ncbi.nlm.nih.gov

[Secondary effects of treatment with maraviroc and other CCR5 antagonists. Potential impact of the CCR5 blocker]. [2020]