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

I

Invivyd

Status and phase

Enrolling
Phase 3

Conditions

COVID-19

Treatments

Drug: COVID-19 mRNA vaccine
Drug: Placebo (Normal Saline)
Drug: VYD2311

Study type

Interventional

Funder types

Industry

Identifiers

NCT07655180
VYD2311-PREV-003

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

All

Ages

18 to 49 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

210 participants in 3 patient groups

Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections
Active Comparator group
Description:
Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations
Treatment:
Drug: Placebo (Normal Saline)
Drug: COVID-19 mRNA vaccine
Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections
Active Comparator group
Description:
Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations
Treatment:
Drug: VYD2311
Drug: Placebo (Normal Saline)
Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections
Active Comparator group
Description:
Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations
Treatment:
Drug: VYD2311
Drug: COVID-19 mRNA vaccine

Trial contacts and locations

1

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Central trial contact

Study Inquiry

Data sourced from clinicaltrials.gov

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