A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
- Conditions
- SARS-CoV-2 InfectionCOVID-19
- Interventions
- Biological: BNT162b2 (Omi XBB.1.5)Biological: BNT162b2 (Omi JN.1)Biological: BNT162b2 (Omi KP.2)
- Registration Number
- NCT05997290
- Lead Sponsor
- BioNTech SE
- Brief Summary
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 "(2024-2025 variant)" 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 "(2024-2025 variant)" (the variant selected for US vaccines to be given in the 2024-2025 season).
* 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 (Cohort 1) 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1051
- 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.
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SSA: Group 1 BNT162b2 (Omi XBB.1.5) Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1. SSB: Group 2 BNT162b2 (Omi XBB.1.5) Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1 SSC: Group 3 BNT162b2 (Omi JN.1) Cohort 1 - Participants 18 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1. SSC: Group 4 BNT162b2 (Omi JN.1) Cohort 2 - Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi JN.1) at Visit 1. SSC - Group 5 BNT162b2 (Omi KP.2) Cohort 3 - Participants 18 years of age and older who will receive 30 µg of BNT162b2 (Omi KP.2) at Visit 1.
- Primary Outcome Measures
Name Time Method SSA: Percentage of participants reporting local reactions For up to 7 days following the study vaccination Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSA: Percentage of participants reporting systemic events For up to 7 days following the study vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
SSA: Percentage of participants reporting adverse events Through 1 month after the study vaccination As elicited by the investigational staff
SSA: Percentage of participants reporting serious adverse events Through 6 months after the study vaccination As elicited by the investigational staff
SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg At 1 month after the study vaccination As measured at the central laboratory
SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg From before study vaccination (Day 1) to 1 month after study vaccination As measured at the central laboratory
SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels At 1 month after the study vaccination As measured at the central laboratory
SSB: Percentage of participants reporting local reactions For up to 7 days following the study vaccination Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSB: Percentage of participants reporting systemic events For up to 7 days following the study vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
SSB: Percentage of participants reporting adverse events Through 1 month after the study vaccination As elicited by the investigational staff.
SSB: Percentage of participants reporting serious adverse events Through 6 months after the study vaccination As elicited by the investigational staff.
SSB: Geometric Mean Ratio (GMR) of the SARS-CoV-2 XBB.1.5-neutralizing titers after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine-experienced participants in SSA. At 1 month after vaccination. As measured at the central laboratory
Difference in percentages of subjects with seroresponse to XBB.1.5 strain after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects compared to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine experienced subjects in SSA At 1 month after vaccination As measured at the central laboratory
SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting local reactions For up to 7 days following the study vaccination Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting systemic events For up to 7 days following the study vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting adverse events Through 1 month after the study vaccination As elicited by the investigational staff
SSC Cohort 1 and Cohort 2 combined: Percentage of participants reporting serious adverse events Through 6 months after the study vaccination As elicited by the investigational staff
SSC Cohort 1 and Cohort 2 combined: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron JN.1- and Omicron XBB.1.5- neutralizing antibody levels for BNT162b2 (Omi JN.1) 30 µg. At 1 month after the study vaccination As measured at the central laboratory
SSC Cohort 1 and Cohort 2 combined: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron JN.1- and Omicron XBB.1.5- neutralizing antibody levels for BNT162b2 (Omi JN.1) 30 µg. From before study vaccination (Day 1) to 1 month after study vaccination As measured at the central laboratory
SSC Cohort 1 and Cohort 2 combined: Percentages of participants with seroresponse to BNT162b2 (Omi JN.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron JN.1- and Omicron XBB.1.5-neutralizing antibody levels. At 1 month after the study vaccination As measured at the central laboratory
SSC Cohort 3: Percentage of participants reporting local reactions For up to 7 days following the study vaccination Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
SSC Cohort 3: Percentage of participants reporting systemic events For up to 7 days following the study vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
SSC Cohort 3: Percentage of participants reporting adverse events Through 1 month after the study vaccination As elicited by the investigational staff
SSC Cohort 3: Percentage of participants reporting serious adverse events Through 6 months after the study vaccination As elicited by the investigational staff
SSC Cohort 3: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron KP.2- and Omicron JN.1- neutralizing antibody levels for BNT162b2 (Omi KP.2) 30 µg. At 1 month after the study vaccination As measured at the central laboratory
SSC Cohort 3: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron KP.2- and Omicron JN.1- neutralizing antibody levels for BNT162b2 (Omi KP.2) 30 µg. From before study vaccination (Day 1) to 1 month after study vaccination As measured at the central laboratory
SSC Cohort 3: Percentages of participants with seroresponse to BNT162b2 (Omi KP.2) 30 µg in terms of GMTs of SARS-CoV-2 Omicron KP.2- and Omicron JN.1- neutralizing antibody levels. At 1 month after the study vaccination As measured at the central laboratory
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
North Alabama Research Center
🇺🇸Athens, Alabama, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Alliance for Multispecialty Research, LLC
🇺🇸Norfolk, Virginia, United States
Epic Medical Research - Surprise
🇺🇸Surprise, 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
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
Epic Medical Research - DeSoto
🇺🇸DeSoto, Texas, United States
DM Clinical Research - Bellaire
🇺🇸Houston, Texas, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, Texas, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States