Purpose

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.

Condition

Eligibility

Eligible Ages
Between 12 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 if permitted by the local health authorities and local ethics committees. 2. Has uninterrupted access to a device (eg, mobile phone, tablet) enabled to receive study reminders (eg, SMS text messages). The parent/guardian of adolescent participants will receive the study reminders. 3. Provides written documentation of informed consent by signing a current IEC/IRB-approved ICF at the time of Screening. In the case of adolescents, parental informed 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 the Investigator. 5. For participants assigned female sex at birth: 1. Is not of childbearing potential, OR 2. Is of childbearing potential and practicing adequate contraception for at least 7 days before dosing on Day 1, agrees to practice adequate contraception through 6 months after any dosing, and has a negative pregnancy test result on Day 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 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 or plans to receive pemivibart within 90 days after Day 1. 2. Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants within 120 days before Day 1 or plans to receive convalescent plasma 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 days before Day 1. 6. Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in the opinion of the investigator or has a fever ≥38 o C (≥100.4 o F) within 3 days of Day 1. 7. Received or plans to receive a non-COVID-19 vaccine within 7 days before or after each dose of study drug. NOTE: Other protocol defined inclusion/exclusion criteria apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Drug: VYD2311-SD
    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
Active Comparator
VYD2311-MD (multidose)
VYD2311 administered via IM injection on Day 1, Day 30, and Day 60
  • Drug: VYD2311-MD
    VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311
Placebo Comparator
Placebo
Normal saline administered by IM injection on Day 1, Day 30, and Day 60
  • Drug: Placebo
    Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline)

Recruiting Locations

Invivyd Investigative Site
Long Beach 5367929, California 5332921 90806
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Inviviyd Investigative Site
San Diego 5391811, California 5332921 92103
Contact:
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Orlando 4167147, Florida 4155751 32819
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Hinesville 4200671, Georgia 4197000 31313
Contact:
Study Inquiry
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Melrose Park 4901868, Illinois 4896861 60160
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Lenexa 4274356, Kansas 4273857 66219
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Silver Spring 4369596, Maryland 4361885 20904
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Burlington 4931737, Massachusetts 6254926 01803
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Southfield 5010636, Michigan 5001836 48034
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Maplewood 5036588, Minnesota 5037779 55109
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Independence 4391812, Missouri 4398678 64055
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Jersey City 5099836, New Jersey 5101760 07306
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
The Bronx 5110266, New York 5128638 10455
Contact:
Declaration
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Philadelphia 4560349, Pennsylvania 6254927 19107
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Myrtle Beach 4588718, South Carolina 4597040 29572
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Goodlettsville 4625282, Tennessee 4662168 37072
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Houston 4699066, Texas 4736286 77065
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Houston-2, Texas 4736286 77065
Contact:
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Irving 4700168, Texas 4736286 75061
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

Invivyd Investigative Site
Sugar Land 4734825, Texas 4736286 46254
Contact:
Declaration
+1 781-819-0080
ClinicalTrials@invivyd.com

More Details

NCT ID
NCT07298434
Status
Recruiting
Sponsor
Invivyd, Inc.

Study Contact

Study Inquiry
+1 781-819-0080
ClinicalTrials@invivyd.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.