Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine

Part of paid clinical trials in Overland Park, Kansas.

Sponsor
Invivyd, Inc.
Study ID
NCT07655180
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 49 Years
Healthy Volunteers
Accepted

Interventions

  • COVID-19 mRNA vaccine — DRUG
    A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
  • VYD2311 — DRUG
    A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
  • Placebo (Normal Saline) — DRUG
    A one-time dose of normal saline (placebo) administered by intramuscular injection.

Study Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections
    Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations
  • Active Comparator: Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections
    Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations
  • Active Comparator: Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections
    Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations

Primary Outcome Measure

Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6 [ Time Frame: Through 6 days after dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Invivyd Investigative SiteOverland ParkKansas66212
Study Inquiry
[email protected]
781-819-0080

Find similar trials in Overland Park, KS

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Invivyd Investigative Site· Overland Park, KS

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