A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
- Conditions
- COVID-19SARS-CoV-2 Infection
- Interventions
- Biological: BNT162b5 Bivalent (WT/OMI BA.2)Biological: BNT162b2 Bivalent (WT/OMI BA.4/BA.5)Biological: BNT162b7 Bivalent (Original/OMI BA.4/BA.5)Biological: BNT162b5 Bivalent (Original/OMI BA.4/BA.5)Biological: BNT162b6 Bivalent (Original/OMI BA.4/BA.5)Biological: BNT162b7 Monovalent (OMI BA.4/BA.5)Biological: BNT162b2 Bivalent (WT/OMI BA.1)
- Registration Number
- NCT05472038
- Lead Sponsor
- BioNTech SE
- Brief Summary
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19.
For all cohorts (groups of participants), this study is seeking participants who are healthy (who may have preexisting disease if it is stable); All participants will receive a single dose of the study vaccine at the first study clinic and will return to the study clinic at least 4 more times. At each clinic visit, a blood sample will be taken. The study is about 6 months long for each participant. The vaccine candidates in this study are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries.
For Cohort 1, this study included participants who were:
* 18 through 55 years of age
* have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before Visit 1 of this study.
All participants in Cohort 1 will receive 1 of the 2 study vaccines at a 30 microgram dose: BNT162b5 Bivalent (WT/OMI BA.2) or BNT162b2 Bivalent (WT/OMI BA.1).
For Cohort 2, this study included participants who were:
* 12 years of age and older
* have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
Participants 12 through 17 years of age will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.
Participants 18 years and older will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at either a 30 microgram or a 60 microgram dose.
For Cohort 3, this study included participants who were:
* 18 years of age and older
* have received 3 prior doses of 30 micrograms BNT162b2, with the last dose being 150 to 365 days before Visit 1 of this study.
* Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 micrograms.
For Cohort 4, this study is seeking participants who are:
* 18 through 55 years of age
* have 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 BA.4/BA.5-adapted bivalent vaccine and dose level at least 150 days before Visit 1 of this study.
All participants in Cohort 4 will receive 1 of the 5 study vaccines at a 30 microgram dose: BNT162b2 Bivalent (Original/ OMI BA.4/BA.5), BNT162b5 Bivalent (Original/OMI BA.4/BA.5), BNT162b6 Bivalent (Original/OMI BA.4/BA.5), BNT162b7 Bivalent (Original/OMI BA.4/BA.5) or BNT162b7 Monovalent (OMI BA.4/BA.5).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1454
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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.
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Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
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Healthy participants (stable pre-existing disease permitted).
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Capable of giving signed informed consent.
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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.
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History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study vaccines.
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Known or suspected immunodeficiency.
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Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
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Women who are pregnant or breastfeeding.
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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.
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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.
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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.
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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.
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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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Cohort 4 only: History of myocarditis or pericarditis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1: BNT162b5 Bivalent (WT/OMI BA.2) BNT162b5 Bivalent (WT/OMI BA.2) Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1. Cohort 2 - Group 4: >55 years; 30 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants over 55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1. Cohort 4: BNT162b7 Bivalent (Original/OMI BA.4/BA.5) BNT162b7 Bivalent (Original/OMI BA.4/BA.5) Participants will receive 30 µg of BNT162b7 Bivalent (Original/OMI BA.4/BA.5) at Visit 1 Cohort 2 -Group 1: 12-17 years; 30 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants 12-17 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1. Cohort 2 - Group 2: 18-55 years; 30 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants 18-55 years old will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1. Cohort 2 - Group 5: >55 years; 60 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants over 55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1. Cohort 3 - Group 2: >55 years; 30 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1. Cohort 4: BNT162b5 Bivalent (Original/OMI BA.4/BA.5) BNT162b5 Bivalent (Original/OMI BA.4/BA.5) Participants will receive 30 µg of BNT162b5 Bivalent (Original/OMI BA.4/BA.5) at Visit 1 Cohort 3 - Group 1: 18-55 years; 30 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants will receive BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg at Visit 1. Cohort 4: BNT162b2 Bivalent (Original/OMI BA.4/BA.5) BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants will receive 30 µg of BNT162b2 Bivalent (Original/OMI BA.4/BA.5) at Visit 1 Cohort 4: BNT162b6 Bivalent (Original/OMI BA.4/BA.5) BNT162b6 Bivalent (Original/OMI BA.4/BA.5) Participants will receive 30 µg of BNT162b6 Bivalent (Original/OMI BA.4/BA.5) at Visit 1 Cohort 4: BNT162b7 Monovalent (OMI BA.4/BA.5) BNT162b7 Monovalent (OMI BA.4/BA.5) Participants will receive 30 µg of BNT162b7 Monovalent (OMI BA.4/BA.5) at Visit 1 Cohort 1: BNT162b2 Bivalent (WT/OMI BA.1) BNT162b2 Bivalent (WT/OMI BA.1) Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1. Cohort 2 - Group 3: 18-55 years; 60 µg BNT162b2 Bivalent (WT/OMI BA.4/BA.5) Participants 18-55 years old will receive 60 µg of BNT162b2 Bivalent (WT/OMI BA.4/BA.5) at Visit 1.
- Primary Outcome Measures
Name Time Method All Cohorts: Percentage of participants reporting serious adverse events For 6 months following the study vaccination As elicited by the investigational staff
Cohort 1: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg At 1 month after study vaccination. As measured at the central laboratory.
Cohorts 2+3 (>55 yrs) Noninferiority analysis: Differences in %s of participants with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg or BNT162b2 30 μg (C4591031 Substudy E). At 1 month after study vaccination. As measured at the central laboratory.
All Cohorts: Percentage of participants reporting local reactions For 7 days following the study vaccination Pain at the injection site, redness, and swelling, as self-reported in electronic diaries
Cohort 1: Percentages of participants with seroresponse to BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg in terms of GMTs of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels. At 1 month after study vaccination. As measured at the central laboratory.
Cohort 2: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg.. From before study vaccination (Day 1) to 1 month after study vaccination. As measured at the central laboratory.
Cohort 2: % of participants with seroresponse to BNT162b2 Bivalent(WT/OMI BA.4/BA.5) 30µg or 60µg and BNT162b2 Bivalent(WT/OMI BA.1) 30µg or 60µg for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), Omicron(BA.1), and reference strain neutralizing antibody levels. At 1 month after study vaccination As measured at the central laboratory.
Cohorts 2+3 (>55 yrs) Superiority analysis: Geometric Mean Ratio (GMR) of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E). At 1 month after study vaccination. As measured at the central laboratory.
Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in participants 18-55 yrs compared to participants >55 yrs. At 1 month after study vaccination. As measured at the central laboratory.
Cohort 4: GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent From before study vaccination (Day 1) to 1 month after study vaccination. As measured at the central laboratory
All Cohorts: Percentage of participants reporting systemic events For 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
All Cohorts: Percentage of participants reporting adverse events For 1 month following the study vaccination As elicited by the investigational staff
Cohort 1: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron (BA.2), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b5 Bivalent (WT/OMI BA.2) 30 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg. From before study vaccination (Day 1) to 1 month after study vaccination. As measured at the central laboratory.
Cohort 2: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5), Omicron (BA.1), and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 µg or 60 µg and BNT162b2 Bivalent (WT/OMI BA.1) 30 µg or 60 µg At 1 month after study vaccination. As measured at the central laboratory.
Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs) Noninferiority analysis: Differences in %s of pts with seroresponse to SARS-CoV-2 Omicron BA.4/BA.5 after vaccination with BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg in pts 18-55 yrs compared to pts >55 yrs. At 1 month after study vaccination. As measured at the central laboratory.
Cohort 4: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent At 1 month after study vaccination As measured at the central laboratory
Cohort 4: % of participants with seroresponse to 30µg BNT162b2 Bivalent, BNT162b5 Bivalent, BNT162b6 Bivalent, BNT162b7 Bivalent and BNT162b7 Monovalent for GMTs of SARS-CoV-2 Omicron(BA.4/BA.5), and reference strain neutralizing antibody levels At 1 month after study vaccination As measured at the central laboratory
- Secondary Outcome Measures
Name Time Method Cohorts 2+3 (18-55 yrs), Cohorts 2+3 (>55 yrs): GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). At 1 month after study vaccination. As measured at the central laboratory.
Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): GMFR (change between 2 timepoints) of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 Substudy E). From before study vaccination (Day 1) to 1 month after study vaccination. As measured at the central laboratory.
Cohorts 2+3 (>55 yrs) Noninferiority analysis: GMR of SARS-CoV-2 reference strain neutralizing antibody levels for BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg to BNT162b2 30 μg (C4591031 Substudy E). At 1 month after study vaccination. As measured at the central laboratory.
Cohorts 2+3 (18-55 yrs), C2+3 (>55 yrs): % of participants with seroresponse to BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 30 μg and BNT162b2 30 μg (C4591031 SSE) for GMTs of SARS-CoV-2 Omicron (BA.4/BA.5) and reference strain neutralizing antibody levels. At 1 month after study vaccination. As measured at the central laboratory.
Trial Locations
- Locations (31)
Bayview Research Group, LLC
🇺🇸Valley Village, California, United States
Clinical Research Professionals
🇺🇸Chesterfield, Missouri, United States
PharmQuest Life Sciences, LLC
🇺🇸Greensboro, North Carolina, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Clinical Neuroscience Solutions Inc.
🇺🇸Memphis, Tennessee, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
🇺🇸Memphis, Tennessee, United States
Sundance Clinical Research
🇺🇸Saint Louis, Missouri, United States
Research Centers of America ( Hollywood )
🇺🇸Hollywood, Florida, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Virginia Research Center
🇺🇸Midlothian, Virginia, United States
Centricity Research Columbus Ohio Multispecialty
🇺🇸Columbus, Ohio, United States
Accellacare - Wilmington
🇺🇸Wilmington, North Carolina, United States
South Jersey Infectious Disease
🇺🇸Somers Point, New Jersey, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Accellacare - Charlotte
🇺🇸Charlotte, North Carolina, United States
Kentucky Pediatric/ Adult Research
🇺🇸Bardstown, Kentucky, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Acevedo Clinical Research Associates
🇺🇸Miami, Florida, United States
Velocity Clinical Research, Omaha
🇺🇸Omaha, Nebraska, United States
Senders Pediatrics
🇺🇸Cleveland, Ohio, United States
California Research Foundation
🇺🇸San Diego, California, United States
Kaiser Permanente Northwest Center for Health Research
🇺🇸Portland, Oregon, United States
DM Clinical Research - Bellaire
🇺🇸Houston, Texas, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, 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
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Benchmark Research
🇺🇸Austin, Texas, United States
Tekton Research, LLC.
🇺🇸Austin, Texas, United States