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Trial record 1 of 1 for:    VIR-2482
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Study of VIR-2482 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04033406
Recruitment Status : Active, not recruiting
First Posted : July 26, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

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.

Condition or disease Intervention/treatment Phase
Influenza A Drug: VIR-2482 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2860 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: VIR-2482
VIR-2482
Drug: VIR-2482
VIR-2482 given by intramuscular injection

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Sterile normal saline (0.9% NaCl) given by intramuscular injection




Primary Outcome Measures :
  1. Number of participants with treatment-emergent adverse events. [ Time Frame: Up to 8 months post-dose ]
  2. Number of participants with abnormalities in vital signs, electrocardiogram (ECG), and clinically significant laboratory findings. [ Time Frame: Up to 8 months post-dose ]
  3. Number of participants with laboratory-confirmed influenza A illness. [ Time Frame: Up to 8 months post-dose ]

Secondary Outcome Measures :
  1. Number of participants with culture-confirmed influenza A illness [ Time Frame: Up to 8 months post-dose ]
  2. Severity and duration of participant-reported signs and symptoms of influenza like illness (ILI) due to influenza A [ Time Frame: Up to 8 months post-dose ]
  3. Quantification of the viral load present in nasopharyngeal secretions at the time of initial symptomatic presentation by RT-qPCR and viral culture [ Time Frame: Up to 8 months post-dose ]
  4. Concentrations of VIR-2482 in serum [ Time Frame: Up to 8 months post-dose ]
  5. Incidence and titers (if applicable) of anti-drug antibody (ADA) to VIR-2482 [ Time Frame: Up to 8 months post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04033406


Locations
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Australia, Queensland
Investigative Site
Brisbane, Queensland, Australia
Sponsors and Collaborators
Vir Biotechnology, Inc.
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Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04033406    
Other Study ID Numbers: VIR-2482-3001
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vir Biotechnology, Inc.:
Influenza A
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases