Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadmi… (NCT07655180) | Clinical Trial Compass
RecruitingPhase 3
Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine
United States210 participantsStarted 2026-06-08
Plain-language summary
The main purposes of this research study are to measure the safety (whether it causes any side effects), tolerability (if it does cause any side effects, how well your body is able to handle them), and reactions, both local at the injection site and systemic, that may occur in the body after receiving VYD2311, or a COVID-19 vaccine, or a combination of VYD2311 and a COVID-19 vaccine in healthy participants. This research study will measure the amount of serum virus neutralizing antibodies produced in the blood (antibodies that block a virus from infecting cells) and pharmacokinetics of VYD2311 compared to a COVID-19 vaccine, when each is administered alone or concurrently. Pharmacokinetics is the study of how a drug moves through the body, including how it is absorbed (taken into the body), distributed (spread throughout the body), metabolized (broken down in the body), and eliminated (removed from the body), and how the body affects the drug.
Who can participate
Age range
18 Years – 49 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening
. Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive.
. Is in good health, with no clinically significant abnormalities as determined by the Investigator based on medical history, physical exam, vital signs, and ECG per study site standard operating procedures.
Exclusion criteria
. Prior receipt of VYD2311 or pemivibart (VYD222).
. Prior receipt of a COVID-19 vaccine within 6 months before Day 0 and prior receipt of a non-COVID-19 vaccine within 28 days before Day 0.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing a COVID-19 vaccine called VYD2311, which can also be given alongside another COVID-19 vaccine — given that it's still in Phase 3, what does that mean for what we currently know about its safety compared to already-approved COVID-19 vaccines?
2The trial is specifically measuring injection site reactions, hypersensitivity reactions, and other side effects in the first 6 days after the shot — based on my personal health history, like any allergies or past vaccine reactions, am I someone who might be at higher risk for those kinds of responses?
3One part of this study involves receiving two COVID-19 vaccines at the same time — is there anything about my current health or immune status that would make getting two vaccines together potentially riskier or less advisable for me?
4Would enrolling in this trial conflict with or delay any standard COVID-19 vaccination I might otherwise receive right now, and would that matter given where we are in the current COVID-19 landscape?
5Since the trial is actively recruiting and the primary focus at this stage is still on safety monitoring rather than confirmed effectiveness, would you recommend I wait for more complete data before considering this, or is there a reason joining now could make sense for my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6
Timeframe: Through 6 days after dose
2
Assessment of systemic reactions solicited via e-diary through day 6
. Prior receipt of convalescent plasma, a mAb to SARS-CoV-2 (other than VYD2311 or pemivibart), or IVIG within 6 months before Day 0.
. Prior known or suspected SARS-CoV-2 infection within 6 months before Day 0.
. Tests positive for current SARS-CoV-2 infection by RAT or local nucleic acid amplification test (eg, RT-PCR) on Day 0.
. Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 0.
. Is acutely ill, including symptoms suggestive of SARS-CoV-2 infection, in the opinion of the investigator or has a fever ≥38oC (≥100.4oF) within 14 days of Day 0.
. Any chronic or significant medical condition that, in the opinion of the Investigator, might compromise participant safety or interfere with evaluation of the study drug or interpretation of participant safety or study results.