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New COVID-19 vaccine boosters target latest variants in large trial

NCT ID NCT05997290

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 updated versions of the Pfizer-BioNTech COVID-19 vaccine designed to target newer Omicron variants (XBB.1.5, JN.1, and KP.2). Over 1,000 healthy people aged 12 and older received a single dose. The main goals were to check safety and measure the immune response. The trial is now complete.

What this could mean

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

Active substance
BNT162b2 mRNA vaccine (updated for Omicron XBB.1.5, JN.1, and KP.2 variants)
What this could lead to
If successful, these updated vaccines could provide better protection against newer COVID-19 variants.
What could go wrong
This is a completed Phase 2/3 trial, but results may not apply to future variants. 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

1,051 people

The number who actually took part.

Started

Aug 2023

Finished

Mar 2025

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.

SSA Inclusion Criteria: * Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1). * 12 years of age and older * Healthy participants (stable pre-existing disease permitted). * Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. * Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. * Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Any 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. * History of myocarditis or pericarditis. * Receipt of 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. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. * Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. * 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. SSB Inclusion Criteria: * COVID-19 vaccine-naïve. * Any positive SARS-CoV-2 test result \>28 days before study intervention administration. * 12 years of age and older. * Healthy participants (stable pre-existing disease permitted). * Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. * Capable of giving or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Any medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * History of myocarditis or pericarditis. * Receipt of 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. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study intervention administration or planned receipt throughout the study. * Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. * 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. SSC Inclusion Criteria: * Cohort 1: 18 years of age and older * Cohort 2: 12 years of age and older * Cohort 3: 18 years of age and older * Healthy participants (stable pre-existing disease permitted). * Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations. * Capable of giving, or parent(s)/legal guardian capable of giving, signed informed consent. Exclusion Criteria * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines. * Immunocompromised with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Any 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. * History of myocarditis or pericarditis. * Receipt of 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. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for the treatment or prevention of COVID-19 or those that are considered immunosuppressive, from 60 days before study vaccination or planned receipt throughout the study. * Receipt of a COVID-19 vaccine less than 150 days before study intervention administration Visit 1 (Day 1). * Participation in other studies involving receipt of other study intervention within 28 days before enrollment. Anticipated participation in other studies involving other study intervention from enrollment through the end of this study. * 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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease 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

  • Acevedo Clinical Research Associates

    Miami, Florida, 33142, United States

  • Alliance for Multispecialty Research, LLC

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research, LLC

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909, United States

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37920, United States

  • Alliance for Multispecialty Research, LLC

    Layton, Utah, 84041, United States

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502, United States

  • Bayview Research Group, LLC

    Valley Village, California, 91607, United States

  • Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)

    Springfield, Missouri, 65807, United States

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO

    Springfield, Missouri, 65802, United States

  • California Research Foundation

    San Diego, California, 92123, United States

  • Care Research - West Flagler Street

    Miami, Florida, 33130, 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.

    Orlando, Florida, 32801, 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

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • DM Clinical Research - Bellaire

    Houston, Texas, 77081, United States

  • Dayton Clinical Research

    Dayton, Ohio, 45409, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • Epic Medical Research - DeSoto

    DeSoto, Texas, 75115, United States

  • Epic Medical Research - Surprise

    Surprise, Arizona, 85378, United States

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229, United States

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012, 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

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004, United States

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612, United States

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801, United States

  • North Alabama Research Center

    Athens, Alabama, 35611, United States

  • SMS Clinical Research

    Mesquite, Texas, 75149, United States

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • West Coast Research

    Dublin, California, 94568, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

More trials for these conditions

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