COVID-19
Conditions
Keywords
COVID-19, COVID, mAb, antibody, VYD2311, LIBERTY, Invivyd, vaccine, SARS-CoV-2 Monocloncal antibody
Brief 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.
Interventions
A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
DRUGVYD2311
A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
DRUGPlacebo (Normal Saline)
A one-time dose of normal saline (placebo) administered by intramuscular injection.
Sponsors
Invivyd, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6 | Through 6 days after dose | — |
| Assessment of systemic reactions solicited via e-diary through day 6 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 56 | Through 56 days after dose |
| sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 56 | Through 56 days after dose |
| Serum concentrations of VYD2311 through Day 56 | Through 56 days after dose |
Countries
United States
Contacts
CONTACTStudy Inquiry
Outcome results
None listed