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New mRNA boosters aim to outsmart omicron variants

NCT ID NCT05472038

Vaccine Sponsor: BioNTech SE 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested several updated mRNA COVID-19 booster vaccines in over 1,400 healthy adults who had already received prior COVID-19 vaccines. The goal was to see if these new boosters are safe and can improve the immune response against newer Omicron variants. Participants received a single shot and were monitored for about six months.

What this could mean

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

Active substance
mRNA vaccine (updated COVID-19 booster)
What this could lead to
If successful, this could lead to better protection against new COVID-19 variants with updated booster shots.
What could go wrong
This is a completed early-to-mid stage trial, so results may not confirm long-term protection. Side effects like injection site pain and fatigue are common.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

1,453 people

The number who actually took part.

Started

Jul 2022

Finished

Mar 2024

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: 1. Age: * Cohort 1: 18 through 55 years of age. * Cohort 2: 12 years of age and older. * Cohort 3: 18 years of age and older. * Cohort 4: 18 through 55 years of age. 2. Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. 3. Healthy participants (stable pre-existing disease permitted). 4. Capable of giving signed informed consent. 5. Prior COVID-19 vaccination history: Cohort 1: \- Received of 1 booster dose of a US-authorized COVID-19 vaccine, with the dose being 90 or more days before first study visit. Documented receipt of all prior COVID-19 vaccines is required. Cohorts 2 and 3: \- Received 3 prior doses of 30 micrograms BNT162b2, with last dose being 150 to 365 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required. Cohort 4: \- Received 3 or 4 prior doses of a US-authorized mRNA COVID-19 vaccine (and dose level), with the last dose being a US-authorized Omicron BA.4/BA.5-adapted vaccine and dose level at least 150 days before first study visit. Documented receipt of all prior COVID-19 vaccines is required. Exclusion Criteria: 1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. 2. Known or suspected immunodeficiency. 3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 4. Women who are pregnant or breastfeeding. 5. Other medical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 6. Immunosuppressants/radiotherapy: Cohorts 1 and 2: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study vaccination through end of study. Cohorts 3 and 4: Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease), or radiotherapy, within 60 days before enrollment or planned receipt through conclusion of the study. 7. Blood/plasma products, immunoglobulin, or monoclonal antibodies: Cohorts 1, 2, 3: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study. Cohort 4: Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for treatment/prevention of COVID-19 or those considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. 8. Other study participation: Cohorts 1 and 2: Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study. Cohorts 3 and 4: Participation in other studies involving receipt of a study intervention within 28 days before randomization. Anticipated participation in other studies involving a study intervention from randomization through the end of this study. 9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. 10. Cohort 4 only: History of myocarditis or pericarditis

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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 SARS-CoV-2 infection

Contacts and locations

Locations

  • Accellacare - Charlotte

    Charlotte, North Carolina, 28211, United States

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142, United States

  • Anaheim Clinical Trials, LLC

    Anaheim, California, 92801, United States

  • Bayview Research Group, LLC

    Valley Village, California, 91607, United States

  • Benchmark Research

    Austin, Texas, 78705, United States

  • California Research Foundation

    San Diego, California, 92123, United States

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213, United States

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119, United States

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256, United States

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281, United States

  • Clinical Research Consulting

    Milford, Connecticut, 06460, United States

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005, United States

  • DM Clinical Research - Bellaire

    Houston, Texas, 77081, United States

  • DM Clinical Research - MDC

    Tomball, Texas, 77375, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109, United States

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121, United States

  • Kaiser Permanente Northwest Center for Health Research

    Portland, Oregon, 97227, United States

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina, 27408, United States

  • Research Centers of America ( Hollywood )

    Hollywood, Florida, 33024, United States

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609, United States

  • Senders Pediatrics

    Cleveland, Ohio, 44121, United States

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244, United States

  • Sundance Clinical Research

    St Louis, Missouri, 63141, United States

  • Tekton Research, LLC.

    Austin, Texas, 78745, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

  • Virginia Research Center

    Midlothian, Virginia, 23114, United States

More trials for these conditions

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