Recruiting
Phase 3

VYD2311 & COVID-19 Vaccine

Sponsor:

Invivyd, Inc.

Code:

NCT07655180

Conditions

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

COVID-19 mRNA vaccine

VYD2311

Placebo (Normal Saline)

Study Details

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.

Conditions

COVID-19

Study ID

NCT07655180

Start date

Jun 8, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

Interventions

COVID-19 mRNA vaccine

A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.

VYD2311

A one-time dose of VYD2311 250mg will be administered by intramuscular injection.

Placebo (Normal Saline)

A one-time dose of normal saline (placebo) administered by intramuscular injection.

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 ]
  • Assessment of systemic reactions solicited via e-diary through day 6 [ Time Frame: Through 6 days after dose ]

Central Contacts and Locations

Central contacts

Locations

Invivyd Investigative Site

Recruiting

Overland Park, Kansas, United States, 66212

Contacts

More Information

Sponsor

Invivyd, Inc.

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • COVID-19
  • COVID
  • mAb
  • antibody
  • VYD2311
  • LIBERTY
  • Invivyd
  • vaccine
  • SARS-CoV-2 Monocloncal antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Invivyd, Inc. on 2026-06-17.