A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals

Completed · Phase 2/Phase 3

Conditions studied: SARS-CoV-2 Infection, COVID-19

In brief

The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people. Substudy A: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before the study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy B: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi XBB.1.5) given as a single 30 µg dose, * in people who are 12 years of age and older, * who are COVID-19 vaccine-naïve * who have had any positive SARS-CoV-2 test result \>28 days before study vaccine administration. * The study is about 6 months long for each participant. * Participants will have at least 5 visits to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken. Substudy C: * This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi JN.1) and BNT162b2 (Omi KP.2) given as a single 30 µg dose to: * Cohort 1: people who are 18 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 2: people who are 12 years of age and older, who will receive BNT162b2 (Omi JN.1), and, * Cohort 3: people who are 18 years of age and older who will receive BNT162b2 (Omi KP.2). * Participants may have never received a COVID-19 vaccine or, may have previously received COVID-19 vaccine(s), with the most recent dose received at least 150 days before the study vaccination (Visit 1). * The study is about 6 months long for each participant. * Participants will have at least 6 visits (Cohorts 1 and 3) or at least 5 visits (Cohort 2) to the clinic. * At each clinic visit a blood sample will be taken. * At least 1 nasal swab will taken.

Key facts

Study ID: NCT05997290
Run by: BioNTech SE
People needed: 1051
Starts: 2023-08-10
Expected to finish: 2025-03-13
Last updated by the study team: 2026-04-28

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

North Alabama Research Center — Athens, Alabama, United States
Medical Affiliated Research Center — Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC — Mobile, Alabama, United States
Epic Medical Research - Surprise — Surprise, Arizona, United States
Alliance for Multispecialty Research, LLC — Tempe, Arizona, United States
West Coast Research — Dublin, California, United States
California Research Foundation — San Diego, California, United States
Bayview Research Group, LLC — Valley Village, California, United States
Diablo Clinical Research, Inc. — Walnut Creek, California, United States
Clinical Research Consulting — Milford, Connecticut, United States
Indago Research & Health Center, Inc — Hialeah, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare — Jacksonville, Florida, United States
Care Research - West Flagler Street — Miami, Florida, United States
Acevedo Clinical Research Associates — Miami, Florida, United States
Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States
Clinical Research Atlanta — Stockbridge, Georgia, United States
East-West Medical Research Institute — Honolulu, Hawaii, United States
Kentucky Pediatric/ Adult Research — Bardstown, Kentucky, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO — Springfield, Missouri, United States
Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only) — Springfield, Missouri, United States
M3 Wake Research, Inc. — Raleigh, North Carolina, United States
Centricity Research Columbus Ohio Multispecialty — Columbus, Ohio, United States
Dayton Clinical Research — Dayton, Ohio, United States
Senders Pediatrics — South Euclid, Ohio, United States
Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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