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New variant-targeted COVID boosters show promise in large trial

NCT ID NCT05289037

Vaccine Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 2 trial tested updated mRNA vaccines designed to target specific COVID-19 variants, including Omicron. Over 1,200 adults who were already vaccinated received one or two doses of these variant vaccines. The goal was to see if these updated shots could boost the immune system's ability to recognize and fight new and emerging variants.

What this could mean

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

Active substance
mRNA vaccines (original and variant-specific) with or without an adjuvant (AS03)
What this could lead to
If successful, this could help design booster shots that better protect against emerging COVID-19 variants.
What could go wrong
This is a Phase 2 trial, so results are still early. The variant-specific vaccines may not offer significantly better protection than existing boosters, and immune responses can vary.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1,270 people

The number who actually took part.

Started

Mar 2022

Finished

Nov 2023

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

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

Ages

18 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: Participants must meet all of the following criteria to be eligible to participate in this study: 1. Individuals \> / = 18 years of age at the time of consent. (18-49 years for stage 4). 2. Confirmed receipt of a complete primary and booster COVID-19 vaccine series, either homologous or heterologous, with an FDA authorized/approved vaccine at least 16 weeks prior to study vaccine dose 1. 3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures. 4. Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Note: Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator. Exclusion Criteria: Participants meeting any of the following criteria will be excluded from the study: 1. Confirmed SARS-CoV-2 infection \< 16 weeks prior to any study vaccine dose. 2. Pregnant and breastfeeding participants. 3. Prior administration of an investigational coronavirus vaccine at any time or SARS-CoV-2 immunoglobulin, monoclonal antibody or plasma antibody therapy in the preceding 3 months. Note: subjects that participated in clinical trials of products that are now FDA approved/authorized are allowed to participate. 4. Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s). 5. A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine, polyethylene glycol (PEG), polysorbate or nanolipid particles. 6. A history of myocarditis or pericarditis at any time prior to enrollment (for subjects in stages 1, 2 and 4). 7. Received or plans to receive a vaccine within 28 days prior to or after any dose of study vaccine. Note: Receipt of seasonal influenza vaccine is allowed at any time. 8. Bleeding disorder diagnosed by a healthcare provider (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or bleeding difficulties with intramuscular injections or blood draws. 9. Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition. 10. Advanced liver or kidney diseases. 11. Advanced (CD4 count \< 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C. 12. Received oral, intramuscular or intravenous systemic immunosuppressants, or immune-modifying drugs for \>14 days in total within 6 months prior to any study vaccine dose (for corticosteroids = 20 mg \> / = day of prednisone equivalent). Note: Topical medications are allowed. 13. Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose. 14. Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose. 15. Study personnel or an immediate family member or household member of study personnel. 16. Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as \> / = 38.0 degrees Celsius/100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods. Note: Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator, as long as the illness is not suggestive of COVID-19. 17. Plan to receive a COVID-19 booster vaccine outside of the study within the next 180 days. (for subjects in Stage 4 only)

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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

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030-3411, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115-6110, United States

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703, United States

  • Emory University School of Medicine

    Atlanta, Georgia, 30322-1013, United States

  • George Washington University Medical Faculty Associates

    Washington D.C., District of Columbia, 20037-3201, United States

  • Howard University - Department of Medicine - Division of Infectious Disease

    Washington D.C., District of Columbia, 20060, United States

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101, United States

  • Morehouse School of Medicine - Clinical Research Center

    Atlanta, Georgia, 30310, United States

  • NYU Grossman School, NYU Langone Vaccine Center, Long Island

    Mineola, New York, 11501, United States

  • NYU Langone Vaccine Center Research Clinic, Manhattan

    New York, New York, 10016, United States

  • Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104-1015, United States

  • The Hope Clinic of Emory University

    Decatur, Georgia, 30030-1705, United States

  • The University of Washington - Virology Research Clinic

    Seattle, Washington, 98104, United States

  • Tulane University Clinical Translational Unit

    New Orleans, Louisiana, 70112, United States

  • University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic

    Birmingham, Alabama, 35294, United States

  • University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)

    San Diego, California, 92103-8208, United States

  • University of Illinois at Chicago College of Medicine - Division of Infectious Diseases

    Chicago, Illinois, 60612, United States

  • University of Iowa Hospitals & Clinics - Department of Internal Medicine

    Iowa City, Iowa, 52242, United States

  • University of Rochester Medical Center - Vaccine Research Unit

    Rochester, New York, 14611-3201, United States

  • University of Texas Medical Branch

    League City, Texas, 77573, United States

  • Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit

    St Louis, Missouri, 63110, United States

  • Zuckerberg San Francisco General Hospital, UCSF Positive Health Program

    San Francisco, California, 94110, United States

More trials for these conditions

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