COVID-19Phase 3LIBERTYNCT07655180
Safety and Serum Virus Neutralizing Antibody Responses of VYD2311, a COVID-19 Vaccine, and Coadministered VYD2311 With a COVID-19 Vaccine
A Phase 3 study testing COVID-19 mRNA vaccine and VYD2311 in people with COVID-19, run by Invivyd, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- COVID-19 mRNA vaccine and VYD2311
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2026to 15 Aug 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Invivyd Investigative Site
Overland Park, Kansas, 66212
About this study
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
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
- Being tested
- COVID-19 mRNA vaccine, VYD2311, Placebo (Normal Saline)
- Keywords
- COVID-19, COVID, mAb, antibody, VYD2311, LIBERTY, Invivyd, vaccine, SARS-CoV-2 Monocloncal antibody
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 mRNA vaccineDrug
A one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection.
VYD2311Drug
A one-time dose of VYD2311 250mg will be administered by intramuscular injection.
Placebo (Normal Saline)Drug
A one-time dose of normal saline (placebo) administered by intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Drug: COVID-19 mRNA vaccine; Drug: VYD2311 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety based on treatment emergent adverse events, injection site reactions, and hypersensitivity reactions through day 6
Measured: 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.
Measured: 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
Measured: Through 56 days after dose
sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 56
Measured: Through 56 days after dose
Serum concentrations of VYD2311 through Day 56
Measured: Through 56 days after dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start8 Jun 2026
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invivyd, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07655180
- Sponsor's protocol ID
- VYD2311-PREV-003
- Acronym
- LIBERTY
- Status last verified
- Oct 2026
- First submitted
- 8 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07655180
- Acronym / sponsor ID
- LIBERTY / VYD2311-PREV-003
- Conditions
- COVID-19
- Keywords
- COVID-19, COVID, mAb, antibody, VYD2311, LIBERTY, Invivyd, vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Invivyd, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1: A COVID-19 vaccine and Placebo administered as 2 separate IM injections | Active comparator | Drug: COVID-19 mRNA vaccine, Drug: Placebo (Normal Saline)Treatment Arm 1: A COVID-19 vaccine administered by IM injection and placebo administered by IM injection in separate locations |
| Treatment Arm 2: VYD2311 and Placebo administered as 2 separate IM injections | Active comparator | Drug: VYD2311, Drug: Placebo (Normal Saline)Treatment Arm 2: VYD2311 250 mg administered by IM injection and placebo administered by IM injection in separate locations |
| Treatment Arm 3: VYD2311 and COVID-19 vaccine administered as 2 separate IM injections | Active comparator | Drug: COVID-19 mRNA vaccine, Drug: VYD2311Treatment Arm 3: VYD2311 250 mg and a COVID-19 vaccine adminstered as two IM injections in separate locations |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 mRNA vaccineA one-time dose of COVID-19 mRNA vaccine will be administered by intramuscular injection. | Drug | 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 |
| VYD2311A one-time dose of VYD2311 250mg will be administered by intramuscular injection. | Drug | 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)A one-time dose of normal saline (placebo) administered by intramuscular injection. | Drug | 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 |
Primary outcome
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
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing COVID-19 mRNA vaccine and VYD2311 in people with COVID-19, run by Invivyd, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.