Menu
Recruiting NCT07655180

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

Phase III Interventional COVID-19

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: COVID-19 mRNA vaccine, VYD2311, Placebo (Normal Saline).
Who it may be relevant to
Registry conditions: COVID-19. Basic parameters: 18 years — 49 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

Primary outcome measures

  • 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]
  • Assessment of systemic reactions solicited via e-diary through day 6 [Time frame: Through 6 days after dose]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

Inclusion criteria

  • Is a healthy adult male or female aged 18 to 49 years, inclusive, weighing at least 40 kg at the time of Screening
  • Has a body mass index (BMI) 18.0 to 32.0 mg/kg2, inclusive.
  • 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

  • Prior receipt of VYD2311 or pemivibart (VYD222).
  • 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.
  • Prior receipt of convalescent plasma, a mAb to SARS-CoV-2 (other than VYD2311 or pemivibart), or IVIG within 6 months before Day 0.
  • Prior known or suspected SARS-CoV-2 infection within 6 months before Day 0.
  • Tests positive for current SARS-CoV-2 infection by RAT or local nucleic acid amplification test (eg, RT-PCR) on Day 0.
  • Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before Day 0.
  • 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Invivyd Investigative Site — Overland Park

Identifiers

NCT: NCT07655180 · VYD2311-PREV-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗