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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections | Active Comparator | Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations |
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| Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections | Active Comparator | Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations |
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| Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections | Active Comparator | Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 mRNA vaccine | Drug | A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Through 6 days after dose |
| Measure | Description | 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 |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Inquiry | Contact | +1 781-819-0080 | clinicaltrials@invivyd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invivyd Investigative Site | Recruiting | Overland Park | Kansas | 66212 | United States |
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| VYD2311 | Drug | A one-time dose of VYD2311 250mg will be administered by intramuscular injection. |
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| Placebo (Normal Saline) | Drug | A one-time dose of normal saline (placebo) administered by intramuscular injection. |
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| Through 56 days after dose |
| Serum concentrations of VYD2311 through Day 56 | Through 56 days after dose |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000722934 | CVnCoV COVID-19 vaccine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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