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COMPLETED
NCT07655180
PHASE3

Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine

Sponsor: Invivyd, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Serum Virus Neutralizing Antibody Responses, and Pharmacokinetics of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine

Key Details

Gender

All

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-06-08

Completion Date

2026-08-15

Last Updated

2026-10-14

Healthy Volunteers

Yes

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.

Locations (1)

Invivyd Investigative Site

Overland Park, Kansas, United States