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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
210
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.
Invivyd Investigative Site
Overland Park, Kansas, United States
RECRUITINGAssessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6
Time frame: Through 6 days after dose
Assessment of systemic reactions solicited via e-diary through day 6
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 6 days after dose
Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 56
Time frame: Through 56 days after dose
sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 56
Time frame: Through 56 days after dose
Serum concentrations of VYD2311 through Day 56
Time frame: Through 56 days after dose
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