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New COVID-19 vaccine candidate tested alone or as a booster with mRNA shots

NCT ID NCT07655180

Vaccine Sponsor: Invivyd, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new COVID-19 vaccine called VYD2311, given alone or together with an existing mRNA COVID-19 vaccine, in healthy adults aged 18 to 49. The goal is to check safety and measure the body's virus-fighting antibody levels. Participants receive one injection and are monitored for side effects and immune responses over 56 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VYD2311 (a COVID-19 vaccine) and a COVID-19 mRNA vaccine
What this could lead to
If successful, this could lead to a new COVID-19 vaccine option that may be given alone or alongside existing mRNA vaccines to boost protection.
What could go wrong
This is a phase 3 trial, but results may not confirm strong protection against all variants. Side effects like injection site reactions or systemic symptoms are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID -19

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Invivyd Investigative Site

    RECRUITING

    Overland Park, Kansas, 66212, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.