NCT07298434

Study of VYD2311 for the Prevention of COVID-19

A Phase 3, Randomized, Triple-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VYD2311 for the Prevention of COVID-19 in Adults and Adolescents

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,770 (estimated)
• Sponsor: Invivyd, Inc. · Industry
• Sex: All
• Age: 12 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. It is being tested in adults and adolescents at least 12 years old. Participants in this study will be given a "study drug" that will be either VYD2311 or placebo. The study drug will be given as a shot into the muscle in the participant's upper thigh or upper arm once a month with a total of 3 shots during the study. This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot. The study will also look at the safety and tolerability of VYD2311, how the study drug is processed by the body (pharmacokinetics), how the immune system reacts to the study drug (immunogenicity), and how well VYD2311 can block the virus from infecting cells (neutralization). To do these tests, your blood will be drawn at certain times during the study.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	VYD2311-SD	VYD2311-SD (single-dose arm): Intramuscular injection dosing on Day 1 with VYD2311 and Intramuscular injection dosing Placebo (normal saline) on Day 30 and Day 60
DRUG	VYD2311-MD	VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311
DRUG	Placebo	Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline)

Timeline

• Start date: 2026-01-08
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2025-12-23
• Last updated: 2026-03-16

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study