A Study to Investigate the Prevention of COVID-19 WithVYD222 in Adults with Immune Compromise and in Participants Aged 12 Years or Older Who Are At Risk of Exposure to SARS-CoV-2

Conditions

COVID-19, SARS-CoV-2

Keywords

Immune Compromise, VYD222, SARS-CoV-2 Monoclonal Antibody, COVID-19 Prevention

Brief summary

A study to investigate the prevention of COVID-19 with VYD222 in adults with immune compromise and in participants aged 12 years or older who are at risk of exposure to SARS-CoV-2

Meredith Leston, Jeremy L. Warner, Kristin Narayan, Ilker Yalcin, David Wilfret et al. (6 authors)

Journal of Clinical Oncology2026-05-27

10.1200/jco.2026.44.16_suppl.2522

A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19.

Yalcin I, Hu L, West B, Narayan K, Holmes A, Wingertzahn MA.

2026-02-16

10.1007/s40121-026-01315-6

Safety and Efficacy of Pemivibart, a Long-Acting Monoclonal Antibody, for Prevention of Symptomatic COVID-19: Interim Results From a Phase 3 Randomized Clinical Trial (CANOPY).

Wolfe CR, Cohen J, Mahoney K, Holmes A, Betancourt N, Gupta D, Tosh K, Narayan K, Campanaro E, Katz C, Phelan AM, Yalcin I, Wingertzahn M, Hawn P, Schmidt P, Li Y, Popejoy M.

2025-10-017 citations

10.1093/cid/ciaf265

91. Clinical Efficacy Endpoints from the Phase 3 CANOPY Study Evaluating Pemivibart

Myra Popejoy, Anna Holmes, Claudio Katz, Anne-Marie Phelan, Kazima Tosh et al. (11 authors)

Open Forum Infectious Diseases2025-01-29

10.1093/ofid/ofae631.028

P-2035. Pharmacokinetics (PK) and Serum Virus Neutralizing Antibody (sVNA) Titers Following the 2nd dose of Pemivibart in the Phase 3 CANOPY Trial

Anna Holmes, Yong Li, Deepali Gupta, Claudio Katz, Mike Gavazzi et al. (8 authors)

Open Forum Infectious Diseases2025-01-29

10.1093/ofid/ofae631.2191

A phase 3 study to evaluate efficacy and safety of VYD222, an IgG1 monoclonal antibody for prevention of COVID-19 (CANOPY): Subset analysis of participants with significant immune compromise in the setting of solid tumor or hematologic malignancies.

Myra W. Popejoy, Kathryn Mahoney, Anne-Marie Phelan, Kristin Narayan, Yong Li et al. (9 authors)

Journal of Clinical Oncology2024-06-011 citations

10.1200/jco.2024.42.16_suppl.2532

Interventions

DRUGVYD222 (pemivibart)

Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with VYD222.

DRUGNormal saline

Participants will be dosed on Day 1 followed by redosing at Month 3 (approximately 90 days) with Placebo.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Only applies to Cohort B

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 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

Exclusion criteria

* 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. Note 1: Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Cohort A - Incidence of treatment emergent adverse events	Through Month 12
Cohort A - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.	Day 28
Cohort B - Incidence of treatment emergent adverse events	Through Month 12

Secondary

Measure	Time frame	Description
Cohort A - ADAs against VYD222	Through Month 12	—
Cohort A - Serum concentrations (PK) of VYD222	Through Month 12	—
Cohort A - Proportion of participants with RT-PCR-confirmed symptomatic COVID-19	Through Month 12	RT-PCR-confirmed symptomatic COVID-19 is defined as RT-PCR-confirmed SARS-CoV-2 with an onset of symptoms occurring no more than 14 days from the date of the positive RT-PCR test sample collection, COVID-19-related hospitalization, or all-cause death.
Cohort B - Ratio of SARS-CoV-2 sVNA titer against a relevant variant following VYD222 administration at Day 28 compared to a prespecified SARS-CoV-2 sVNA titer threshold.	Day 28	—
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.	Day 28	—
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration at Day 28 above a prespecified SARS-CoV-2 sVNA titer threshold.	Day 28	—
Cohort B - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint	Through Month 12	The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.
Cohort B - COVID-19-related hospitalization or COVID-19-related death within 28 days of symptom onset	Through Month 12	—
Cohort B - COVID-19-related death	Through Month 12	—
Cohort B - Serum concentrations (PK) of VYD222	Through Month 12	—
Cohort B - ADAs against VYD222	Through Month 12	—
Cohort B - sVNA titer by timepoint following VYD222 administration	Through Month 12	—
Cohort A - sVNA titer by timepoint following VYD222 administration	Through Month 12	—
Cohort A - Proportion of participants with sVNA titer against a relevant variant following VYD222 administration above a minimum SARS-CoV-2 sVNA threshold by timepoint	Through Month 12	The minimum SARS-CoV-2 sVNA titer threshold will be prespecified prior to analysis.

Countries

United States

Outcome results

None listed