The main purpose of this study is to test an investigational drug known as VYD2311, whichis being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonalantibody that attaches to the virus that causes COVID-19 and helps block it from enteringyour 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 orplacebo.The study drug will be given as a shot into the muscle in the participant's upper thighor 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 duringthe 90 days after the first shot. The study will also look at the safety and tolerabilityof VYD2311, how the study drug is processed by the body (pharmacokinetics), how theimmune system reacts to the study drug (immunogenicity), and how well VYD2311 can blockthe virus from infecting cells (neutralization). To do these tests, your blood will bedrawn at certain times during the study.
Not Provided
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
Drug: VYD2311-MD
VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with
VYD2311
Drug: Placebo
Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline)
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
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
Invivyd Investigative Site
Independence, Missouri, United States
Invivyd Investigative Site
Jersey City, New Jersey, United States
Invivyd Investigative Site
The Bronx, New York, United States
Invivyd Investigative Site
Philadelphia, Pennsylvania, United States
Invivyd Investigative Site
Myrtle Beach, South Carolina, United States
Invivyd Investigative Site
Goodlettsville, Tennessee, United States
Invivyd Investigative Site
Houston, Texas, United States
Invivyd Investigative Site
Houston-2, Texas, United States
Invivyd Investigative Site
Irving, Texas, United States
Invivyd Investigative Site
Sugar Land, Texas, United States
Not Provided