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Can one shot boost omicron defenses for the most vulnerable?

NCT ID NCT07861542

Prevention Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 06, 2026 · Last updated Oct 16, 2026 · Updated 3 times

Summary

Researchers are testing a single dose of an omicron-based COVID-19 vaccine called Nuvaxovid in people aged 65 and older, and in people aged 12 to 64 who have a health condition that raises their risk of severe COVID-19. All participants received a COVID-19 vaccine at least 90 days before joining. The study measures antibody levels against the omicron subvariant in the vaccine over about three months to see whether the shot triggers a strong immune response.

What this could mean

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

Active substance
an omicron subvariant-based COVID-19 vaccine with Matrix-M adjuvant, also known as Nuvaxovid
What this could lead to
If it works, this could offer older adults and at-risk people a single-dose booster that broadens protection against newer omicron subvariants.
What could go wrong
This is a small, short study that only measures antibody levels, not whether people actually avoid getting sick. Antibody responses may not translate into real-world protection, and side effects like soreness or fatigue 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 660 people

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

Started

Oct 2026

Expected to finish

Jan 2027

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

12 years and older

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: To be included in this study, each individual must satisfy all the following criteria: * Participants ≥ 65 years of age, or participants 12 through 64 years of age who have at least 1 underlying condition that puts them at increased risk for severe outcomes from COVID-19 at the time of study vaccination. * Previously vaccinated with a COVID-19 vaccine, with the last dose administered ≥ 90 days prior to study vaccination. * Participants must not be pregnant or breastfeeding. Participants of childbearing potential must have a negative highly sensitive pregnancy test at enrollment and must agree to use an effective method of contraception or remain abstinent from ≥ 4 weeks before study vaccination through ≥ 4 weeks after vaccination. Exclusion Criteria: Participants are not eligible if any of the following criteria are met: * Known or suspected congenital or acquired immunodeficiency; receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the past 6 months; or long-term use of systemic corticosteroids. * History of virologically confirmed SARS-CoV-2 infection within 90 days before study vaccination. * Known systemic hypersensitivity to any component of the study intervention or a history of a life-threatening reaction to the study intervention or to a product containing the same substances. * Prior history of myocarditis, pericarditis, or myopericarditis. * Receipt of any vaccine within 28 days before study vaccination, except for influenza vaccine, which may be administered at least 14 days before study vaccination. * Receipt of an investigational or marketed COVID-19 vaccine within 90 days before study vaccination. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

COVID-19

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

    20 sites. 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

  • Site #: 8400001

    RECRUITING

    Lafayette, Louisiana, 70508, United States

  • Site #: 8400002

    RECRUITING

    Doral, Florida, 33172, United States

  • Site #: 8400003

    RECRUITING

    New Orleans, Louisiana, 70115, United States

  • Site #: 8400004

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Site #: 8400005

    RECRUITING

    Fair Oaks, California, 95628, United States

  • Site #: 8400007

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Site #: 8400008

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Site #: 8400009

    RECRUITING

    Lenexa, Kansas, 66219, United States

  • Site #: 8400011

    RECRUITING

    Melrose Park, Illinois, 60160, United States

  • Site #: 8400012

    RECRUITING

    Southfield, Michigan, 48076, United States

  • Site #: 8400013

    RECRUITING

    Richmond, Virginia, 23226, United States

  • Site #: 8400014

    RECRUITING

    Houston, Texas, 77065, United States

  • Site #: 8400015

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Site #: 8400016

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Site #: 8400017

    RECRUITING

    Frisco, Texas, 75033, United States

  • Site #: 8400018

    RECRUITING

    Austin, Texas, 78750, United States

  • Site #: 8400019

    RECRUITING

    Sioux City, Iowa, 51106, United States

  • Site #: 8400021

    RECRUITING

    Omaha, Nebraska, 68134, United States

  • Site #: 8400023

    RECRUITING

    Grand Island, Nebraska, 68803, United States

  • Site #: 8400024

    RECRUITING

    Rockville, Maryland, 20854, United States

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