Invivyd Investigative Site
Overland Park, Kansas, 66212, United States
Location status: Recruiting
NCT Number: NCT07655180
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.
Interested in participating?
Request Info18 year–49 year
All sexes
Interventional
Phase 3
Overland Park, Kansas, 66212, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOTE: The above information is not intended to contain all considerations relevant to a participant's potential eligibility in the clinical trial.
A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
A one-time dose of normal saline (placebo) administered by intramuscular injection.
Time frame: Through 6 days after dose
Time frame: Through 6 days after dose
To compare the systemic reaction of VYD2311 (study drug) with a COVID-19 vaccine when administered alone or concurrently in healthy adults. E-diaries will solicit participant reported systemic reactions including vomiting, fever, diarrhea, headache, fatigue, chills, myalgia, and arthralgia.
Time frame: Through 56 days after dose
Time frame: Through 56 days after dose
Time frame: Through 56 days after dose
Contact information is provided by the study sponsor or research team.
Invivyd, Inc.
Industry
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Serum Virus Neutralizing Antibody Responses, and Pharmacokinetics of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine
Acronym: LIBERTY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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