Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine
NCT07655180 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210
Last updated 2026-06-17
Summary
The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants. This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently. Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug.
Conditions
Interventions
- DRUG
-
COVID-19 mRNA vaccine
A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
- DRUG
-
VYD2311
A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
- DRUG
-
Placebo (Normal Saline)
A one-time dose of normal saline (placebo) administered by intramuscular injection.
Sponsors & Collaborators
-
Invivyd, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-08
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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