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

NCT07655180 | Recruiting Phase 3 FDA Drug

• 1 other identifier: VYD2311-PREV-003
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

  Through 56 days after dose

• Serum concentrations of VYD2311 through Day 56

  Through 56 days after dose

Study Arms (3)

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

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

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

Drug: VYD2311; Drug: Placebo (Normal Saline)

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

Drug: COVID-19 mRNA vaccine; Drug: VYD2311

Interventions

COVID-19 mRNA vaccine DRUG

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

Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections; Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections

VYD2311 DRUG

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

Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections; Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections

Placebo (Normal Saline) DRUG

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

Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections; Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Invivyd, Inc.: lead

Study Sites (1)

Invivyd Investigative Site

Overland Park, Kansas, 66212, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine; Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Study Inquiry

CONTACT

+1 781-819-0080; clinicaltrials@invivyd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 17, 2026
• Study Start: June 8, 2026
• Primary Completion: August 1, 2026
• Study Completion: August 1, 2026
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)