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COVID-19Phase 3COVID-19NCT07079670

Safety and Immunogenicity of NVX-CoV2705

A Phase 3 study testing NVX-CoV2705 in people with COVID-19 and SARS-CoV-2 Infection, run by Sanofi at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120 participants. Read more about this study

Who is it for?
Ages 12 to 90 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2 Infection
What is being tested?
NVX-CoV2705
Could I receive a placebo?
No, everyone receives an active treatment
How many people
676 participants
Where
10 sitesUnited States
Study dates
9 Oct 2025to 11 May 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 12 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • To be included in this study, each individual must satisfy all the following criteria:
  • Participants ≥ 65 years of age and participants 12 through 64 years who have at least one underlying condition that puts them at high risk of severe outcomes from COVID-19 at time of study vaccination. In each instance, the investigator's judgment may be exercised and other eligibility criteria must be respected.
  • Previously vaccinated with a COVID-19 vaccine with the last dose administered ≥ 90 days prior to study vaccination (written or verbal confirmation by participant).
  • Participant and parent(s)/caregiver(s) or legally acceptable representative willing and able to give informed consent and assent prior to study enrollment and to comply with study procedures.
  • Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea ≥ 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from ≥ 28 days prior to enrollment and through the end of the study.
  • Condoms (male or female) with spermicide (if acceptable in country)
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  • Diaphragm with spermicide
  • Cervical cap with spermicide
  • Intrauterine device
  • Oral or patch contraceptives
  • Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy
  • Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and physical examination. Vital signs must be within medically acceptable ranges prior to study vaccination. If the individual has a diagnosis of hypertension, it must be stable and controlled with necessary medication.
  • Agrees not to participate in any research involving receipt of investigational products (drug/biologic/device), including other SARS-CoV-2 prevention or treatment trials, for the duration of the study.

Who cannot join

  • If an individual meets any of the following criteria, he or she is ineligible for this study:
  • Current participation in research involving receipt of investigational products (drug/biologic/device).
  • Received any other vaccine (except for a licensed seasonal influenza vaccine or rabies vaccine [if medically indicated]) within 28 days prior to study vaccination. For the influenza vaccine, a participant is eligible as long as the vaccine was administered ≥ 14 days prior to study vaccination.
  • Any known history of allergies to products contained in the investigational product in the participant's lifetime.
  • Any known history of anaphylaxis to any prior vaccine in the participant's lifetime.
  • Known history of myocarditis or pericarditis in the participant's lifetime.
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  • Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination that, in the opinion of the investigator, might interfere with protocol compliance.
  • Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) that requires the use of immune modulators.
  • NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis, are NOT excluded.
  • Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination (Day 0).
  • NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted.
  • Received any prohibited medication (see Section 7.3), immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination (Day 0).
  • Active cancer (malignancy) on chemotherapy within 3 years prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
  • Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
  • Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
  • Temperature of > 38°C/≥ 100.4°F (oral measurement) or respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing) leading up to Day 0.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Investigational Site Number US047

    Austin, Texas, 78705-3298

  • Investigational Site Number US381

    Cincinnati, Ohio, 45246-2316

  • Investigational Site Number US294

    Lafayette, Louisiana, 70508

  • Investigational Site Number US406

    Lenexa, Kansas, 66219

  • Investigational Site Number US395

    Melrose Park, Illinois, 60160

  • Investigational Site Number US326

    Omaha, Nebraska, 68134

  • Investigational Site Number US404

    Phoenix, Arizona, 85044

  • Investigational Site Number US391

    Pleasant View, Utah, 84404-4791

  • Investigational Site Number US407

    Southfield, Michigan, 48076-5412

  • Investigational Site Number US073

    Tomball, Texas, 77375

Other trials in United States

About this study

Official title: A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted With Matrix-M

This study is a Phase 3 trial designed to check the safety and immune response to a new Omicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine, called NVX-CoV2705, to approximately 120 participants. This includes adults aged 65 and older, and individuals aged 12 to 64 who have existing health conditions that put them at high risk for severe COVID-19. All participants must have received a previous COVID-19 vaccine at least 90 days before joining this study. Study researchers will be closely monitoring participants for their immune response for 28 days and collecting safety data for 180 days after vaccination.

Read the detailed description

This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M® (NVX-CoV2705) in participants ≥ 65 years of age and participants 12 through 64 years of age who have at least one underlying condition that puts them at high risk for severe outcomes from coronavirus disease 2019 (COVID 19) previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination. The goal will be to enroll a similar number of participants in the 2 age cohorts (≥ 65 years and 12 through 64 years) and in the 12 through 64 years age cohort, an effort will be made to enroll a similar number of participants in the 2 age subcohorts (12 through 17 years and 18 through 64 years).

Approximately 120 participants, approximately 60 participants in each age cohort and approximately 30 participants in each age subcohort, will be enrolled to receive a single dose of NVX-CoV2705 on Day 0 and remain on study for immunogenicity until Day 28 and safety data collection through 180 days post-vaccination.

Being tested
NVX-CoV2705
Keywords
COVID-19
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NVX-CoV2705Biological

    Also called Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted with Matrix-M

    Intramuscular (deltoid) injection at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.

Study groups in NCT07079670
Study groupRoleWhat they receive
NVX-CoV2705ExperimentalNVX-CoV2705 vaccine in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant.
Receives: Biological: NVX-CoV2705

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMFR

    Pseudovirus neutralization (ID50) GMFR for the Omicron JN.1 subvariant at Day 28 following study vaccination.

    Measured: Day 28

Secondary outcomes (5)

  1. Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMT

    Pseudovirus neutralization (ID50) GMTs for the Omicron JN.1 subvariant at Day 28 following study vaccination.

    Measured: Day 28

  2. Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as SRR

    SRRs in ID50 titers for the Omicron JN.1 subvariant assessed at Day 28 following study vaccination.

    Measured: Day 28

  3. Number of Participants Reported Solicited Local and Systemic Adverse Events (AEs)

    Number of participants reported solicited local and systemic adverse events (AEs)

    Measured: Day 28

  4. Number of Participants Reported any unsolicited AEs and MAAEs

    Incidence, severity, and relationship of any unsolicited AEs and MAAEs through 28 days after vaccination.

    Measured: Day 28

  5. Number of Participants Reported MAAEs Attributed to Study Vaccine, Adverse Events of Special Interest (AESIs), and Serious Adverse Events (SAEs)

    • Incidence and severity of treatment-related MAAEs, AESIs (predefined list, including PIMMCs and myocarditis and/or pericarditis), and SAEs through Day 180/EoS.

    Measured: Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2025
  2. Study start9 Oct 2025
  3. Primary completion12 Jan 2026
  4. Study completion11 May 2026

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
676 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07079670
Sponsor's protocol ID
2019nCoV-318
Other IDs
VBV23344
Acronym
COVID-19
Status last verified
Jun 2026
First submitted
14 Jul 2025
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NVX-CoV2705 in people with COVID-19 and SARS-CoV-2 Infection, run by Sanofi at 10 sites 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 14 inclusion and 18 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 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Pseudovirus neutralization (ID50) of Omicron JN.1 subvariant vaccine expressed as GMFR (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07079670.

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 5 Jun 2026.

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