Study of VYD2311 for the Prevention of COVID-19

Last updated: June 8, 2026
Sponsor: Invivyd, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Covid-19

Treatment

Placebo

VYD2311-SD

VYD2311-MD

Clinical Study ID

NCT07298434
VYD2311-PREV-002
  • Ages 12-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Participants are eligible to be included in the study only if all the following criteria apply:

  1. Is an adult aged ≥18 years or an adolescent aged 12 to <18 years weighing at least 40 kg at the time of Screening. Note: Adolescent enrollment is allowed only ifpermitted by the local health authorities and local ethics committees.

  2. Has uninterrupted access to a device (eg, mobile phone, tablet) enabled to receivestudy reminders (eg, SMS text messages). The parent/guardian of adolescentparticipants will receive the study reminders.

  3. Provides written documentation of informed consent by signing a currentIEC/IRB-approved ICF at the time of Screening. In the case of adolescents, parentalinformed consent and adolescent assent must also be obtained.

  4. Is able to understand and comply with study requirements/procedures (if applicable,with assistance by a caregiver, surrogate, or LAR) based on the assessment of theInvestigator.

  5. For participants assigned female sex at birth:

  6. Is not of childbearing potential, OR

  7. Is of childbearing potential and practicing adequate contraception for at least 7 days before dosing on Day 1, agrees to practice adequate contraceptionthrough 6 months after any dosing, and has a negative pregnancy test result onDay 1.

Note: Pregnant participants will be eligible for enrollment after iDMC review of safety data only upon Sponsor communication to sites and only in regions permitted by local health authorities and local ethics committees. If pregnant participants are eligible for enrollment, this criterion is no longer applicable.

Exclusion

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  1. Prior receipt of VYD2311 or pemivibart (VYD222) within 12 months before Day 1 orplans to receive pemivibart within 90 days after Day 1.

  2. Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currentlycirculating variants within 120 days before Day 1 or plans to receive convalescentplasma or an active SARS-CoV-2 mAb within 90 days after Day 1.

  3. Tests positive for current SARS-CoV-2 infection by local RAT or RT-PCR on Day 1.

  4. Prior known or suspected SARS-CoV-2 infection within 120 days before Day 1.

  5. Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 daysbefore Day 1.

  6. Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in theopinion of the investigator or has a fever ≥38 o C (≥100.4 o F) within 3 days of Day

  7. Received or plans to receive a non-COVID-19 vaccine within 7 days before or aftereach dose of study drug.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Total Participants: 1770
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
January 08, 2026
Estimated Completion Date:
August 31, 2026

Connect with a study center

  • Invivyd Investigative Site

    Long Beach, California 90806
    United States

    Site Not Available

  • Inviviyd Investigative Site

    San Diego, California 92103
    United States

    Site Not Available

  • Invivyd Investigative Site

    Orlando, Florida 32819
    United States

    Site Not Available

  • Invivyd Investigative Site

    Hinesville, Georgia 31313
    United States

    Site Not Available

  • Invivyd Investigative Site

    Melrose Park, Illinois 60160
    United States

    Site Not Available

  • Invivyd Investigative Site

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Invivyd Investigative Site

    Silver Spring, Maryland 20904
    United States

    Site Not Available

  • Invivyd Investigative Site

    Burlington, Massachusetts 01803
    United States

    Site Not Available

  • Invivyd Investigative Site

    Southfield, Michigan 48034
    United States

    Site Not Available

  • Invivyd Investigative Site

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Invivyd Investigative Site

    Independence, Missouri 64055
    United States

    Site Not Available

  • Invivyd Investigative Site

    Jersey City, New Jersey 07306
    United States

    Site Not Available

  • Invivyd Investigative Site

    The Bronx, New York 10455
    United States

    Site Not Available

  • Invivyd Investigative Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Invivyd Investigative Site

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Invivyd Investigative Site

    Goodlettsville, Tennessee 37072
    United States

    Site Not Available

  • Invivyd Investigative Site

    Houston, Texas 77065
    United States

    Site Not Available

  • Invivyd Investigative Site

    Houston-2, Texas 77065
    United States

    Site Not Available

  • Invivyd Investigative Site

    Irving, Texas 75061
    United States

    Site Not Available

  • Invivyd Investigative Site

    Sugar Land, Texas 46254
    United States

    Site Not Available

  • Invivyd Investigative Site

    Houston 4699066, Texas 4736286 77065
    United States

    Site Not Available

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