Study of VYD2311 for the Prevention of COVID-19

Part of paid clinical trials in Long Beach, California.

Sponsor
Invivyd, Inc.
Study ID
NCT07298434
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • VYD2311-SD — DRUG
    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
  • VYD2311-MD — DRUG
    VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311
  • Placebo — DRUG
    Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline)

Study Details

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.

Key Dates

Start date
Jan 8, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
1,770 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: VYD2311-SD (single dose)
    VYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride \[normal saline\]) on Day 30 and Day 60
  • Active Comparator: VYD2311-MD (multidose)
    VYD2311 administered via IM injection on Day 1, Day 30, and Day 60
  • Placebo Comparator: Placebo
    Normal saline administered by IM injection on Day 1, Day 30, and Day 60

Primary Outcome Measure

RT-PCR-confirmed symptomatic COVID-19 through Day 90 [ Time Frame: 90 days ]

Locations (20)

FacilityCityStateZIPSite coordinators
Invivyd Investigative SiteLong BeachCalifornia90806-
Inviviyd Investigative SiteSan DiegoCalifornia92103-
Invivyd Investigative SiteOrlandoFlorida32819-
Invivyd Investigative SiteHinesvilleGeorgia31313-
Invivyd Investigative SiteMelrose ParkIllinois60160-
Invivyd Investigative SiteLenexaKansas66219-
Invivyd Investigative SiteSilver SpringMaryland20904-
Invivyd Investigative SiteBurlingtonMassachusetts01803-
Invivyd Investigative SiteSouthfieldMichigan48034-
Invivyd Investigative SiteMaplewoodMinnesota55109-
Invivyd Investigative SiteIndependenceMissouri64055-
Invivyd Investigative SiteJersey CityNew Jersey07306-
Invivyd Investigative SiteThe BronxNew York10455-
Invivyd Investigative SitePhiladelphiaPennsylvania19107-
Invivyd Investigative SiteMyrtle BeachSouth Carolina29572-
Invivyd Investigative SiteGoodlettsvilleTennessee37072-
Invivyd Investigative SiteHoustonTexas77065-
Invivyd Investigative SiteHouston-2Texas77065-
Invivyd Investigative SiteIrvingTexas75061-
Invivyd Investigative SiteSugar LandTexas46254-

Find similar trials in Long Beach, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Invivyd Investigative Site· Long Beach, CAInviviyd Investigative Site· San Diego, CAInvivyd Investigative Site· Orlando, FLInvivyd Investigative Site· Hinesville, GAInvivyd Investigative Site· Melrose Park, ILInvivyd Investigative Site· Lenexa, KS

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