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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
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.
Age
12 - 100 years
Sex
ALL
Healthy Volunteers
Yes
Invivyd Investigative Site
Long Beach, California, United States
Inviviyd Investigative Site
San Diego, California, United States
Invivyd Investigative Site
Orlando, Florida, United States
Invivyd Investigative Site
Hinesville, Georgia, United States
Invivyd Investigative Site
Melrose Park, Illinois, United States
Invivyd Investigative Site
Lenexa, Kansas, United States
Invivyd Investigative Site
Silver Spring, Maryland, United States
Invivyd Investigative Site
Burlington, Massachusetts, United States
Invivyd Investigative Site
Southfield, Michigan, United States
Invivyd Investigative Site
Maplewood, Minnesota, United States
Start Date
January 8, 2026
Primary Completion Date
March 1, 2026
Completion Date
June 1, 2026
Last Updated
March 16, 2026
1,770
ESTIMATED participants
VYD2311-SD
DRUG
VYD2311-MD
DRUG
Placebo
DRUG
Lead Sponsor
Invivyd, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06631287