Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine
Recruiting
Phase 3Interventional Study
COVID-19
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 49
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
210 (estimated)
Sponsor
Invivyd, Inc. · Industry
Who this trial is looking for
This trial is looking for healthy adults aged 18 to 49 to see how safe the VYD2311 vaccine is and how it works in the body. Participants will receive either the VYD2311 vaccine, a COVID-19 vaccine, or both and will be monitored for any side effects.
Are You a Good Fit for This Trial?
You may be able to join if
I am a healthy adult aged 18 to 49 years
I weigh at least 40 kg
I have a BMI between 18.0 and 32.0
I am in good health according to medical checks
You may not be able to join if
I have had VYD2311 or pemivibart before
I have received a COVID-19 vaccine in the past 6 months
I have received a non-COVID-19 vaccine in the past 28 days
I have had convalescent plasma or SARS-CoV-2 mAb in the past 6 months
I have known or suspected SARS-CoV-2 infection in the past 6 months
I tested positive for SARS-CoV-2 on Day 0
I have been in close contact with someone with SARS-CoV-2 in the last 5 days
I am currently ill with symptoms of SARS-CoV-2 or have a fever in the last 14 days
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 par…
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.
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Eligibility Criteria
Inclusion Criteria:
1. Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening
2. Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive.
3. Is in good health, with no clinically significant abnormalities as determined by the Investigat…
Inclusion Criteria:
1. Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening
2. Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive.
3. 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:
1. Prior receipt of VYD2311 or pemivibart (VYD222).
2. 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.
3. Prior receipt of convalescent plasma, a mAb to SARS-CoV-2 (other than VYD2311 or pemivibart), or IVIG within 6 months before Day 0.
4. Prior known or suspected SARS-CoV-2 infection within 6 months before Day 0.
5. Tests positive for current SARS-CoV-2 infection by RAT or local nucleic acid amplification test (eg, RT-PCR) on Day 0.
6. Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 0.
7. 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.
8. 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.
NOTE: The above information is not intended to contain all considerations relevant to a participant's potential eligibility in the clinical trial.
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