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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
Led by Invivyd, Inc. · Updated on 2026-05-15
1770
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating an investigational drug called VYD2311, a monoclonal antibody designed to reduce the risk of getting COVID-19. This study includes adults and adolescents aged 12 years and older. Participants will receive either VYD2311 or a placebo to assess how well VYD2311 prevents COVID-19 infection. The study also examines the safety, how the drug is processed by the body, immune responses, and the drug's ability to block the virus. Participants will receive three monthly injections as part of one of three groups: a single dose of VYD2311 followed by placebo injections, multiple doses of VYD2311, or placebo injections only. The injections are given into the muscle of the upper thigh or upper arm on Day 1, Day 30, and Day 60. During the 90 days following the first injection, participants will have blood drawn at specific times to measure drug levels, immune reactions, and virus neutralization. Researchers will monitor for COVID-19 symptoms confirmed by testing, safety through reports of side effects, and overall drug tolerability. The total study participation lasts approximately 90 days after the first dose.
CONDITIONS
Brief Title
Study of VYD2311 for the Prevention of COVID-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, or adolescent aged 12 to under 18 years weighing at least 40 kg
- Access to a device such as a mobile phone or tablet to receive study reminders
- Provides written informed consent (and assent with parental consent for adolescents)
- Able to understand and follow study procedures
- If female assigned at birth, either not of childbearing potential or practicing adequate contraception with a negative pregnancy test on Day 1
You will not qualify if you...
- Prior receipt of VYD2311 or pemivibart within 12 months before Day 1 or plans to receive pemivibart within 90 days after Day 1
- Prior receipt of convalescent plasma or active SARS-CoV-2 monoclonal antibody within 120 days before Day 1 or plans to receive within 90 days after Day 1
- Positive test for current SARS-CoV-2 infection on Day 1
- Known or suspected SARS-CoV-2 infection within 120 days before Day 1
- Exposure to someone with known or suspected SARS-CoV-2 infection within 5 days before Day 1
- Acute illness or fever of 38°C or higher within 3 days before Day 1
- Received or plans to receive a non-COVID-19 vaccine within 7 days before or after each study dose
- Other protocol-defined criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 months
Participants receive intramuscular injections of VYD2311 or placebo on Day 1, Day 30, and Day 60 depending on their assigned group.
3 visits (in-person) for dosing on Day 1, Day 30, and Day 60
Duration - Up to 30 days after the last dose (Day 90 total)
Participants are monitored for safety and efficacy outcomes through Day 90 after initial dosing.
1 or more visits for safety and efficacy assessments up to Day 90
Trial Site Locations
Total: 20 locations
1
Invivyd Investigative Site
Long Beach, California, United States, 90806
Actively Recruiting
2
Inviviyd Investigative Site
San Diego, California, United States, 92103
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3
Invivyd Investigative Site
Orlando, Florida, United States, 32819
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4
Invivyd Investigative Site
Hinesville, Georgia, United States, 31313
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5
Invivyd Investigative Site
Melrose Park, Illinois, United States, 60160
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6
Invivyd Investigative Site
Lenexa, Kansas, United States, 66219
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7
Invivyd Investigative Site
Silver Spring, Maryland, United States, 20904
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8
Invivyd Investigative Site
Burlington, Massachusetts, United States, 01803
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9
Invivyd Investigative Site
Southfield, Michigan, United States, 48034
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10
Invivyd Investigative Site
Maplewood, Minnesota, United States, 55109
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11
Invivyd Investigative Site
Independence, Missouri, United States, 64055
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12
Invivyd Investigative Site
Jersey City, New Jersey, United States, 07306
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13
Invivyd Investigative Site
The Bronx, New York, United States, 10455
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14
Invivyd Investigative Site
Philadelphia, Pennsylvania, United States, 19107
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15
Invivyd Investigative Site
Myrtle Beach, South Carolina, United States, 29572
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16
Invivyd Investigative Site
Goodlettsville, Tennessee, United States, 37072
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17
Invivyd Investigative Site
Houston, Texas, United States, 77065
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18
Invivyd Investigative Site
Houston-2, Texas, United States, 77065
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19
Invivyd Investigative Site
Irving, Texas, United States, 75061
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20
Invivyd Investigative Site
Sugar Land, Texas, United States, 46254
Actively Recruiting
Research Team
S
Study Inquiry
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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