Lead Sponsor

Invivyd, Inc.

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

No

•Is an adult aged ≥18 years or an adolescent aged 12 to \<18 years and weighs at least 40 kg at the time of Screening.
•Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at the time of Screening.
•For Cohort A, has significant immune compromise from causes including solid tumor or hematologic malignancies, chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic stem cell transplant, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies.
•For Cohort B, is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings.
•Agrees to defer receipt of any COVID-19 vaccination or booster for a minimum of 28 days after dosing.
•Note: unless specified by Cohort, the criteria apply to both Cohorts

•For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization.
•Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization.
•Prior known or suspected SARS-CoV-2 infection within 120 days before randomization.
•Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization.
•Is acutely ill or has any symptoms suggestive of infection, in the opinion of the Investigator.

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