A Study to Learn About a New COVID-19 RNA Vaccine Candidate as a Booster Dose in COVID-19 Vaccine-Experienced Healthy Adults
Study Details
Study Description
Brief Summary
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of a BNT162b, RNA-based SARS-CoV-2 vaccine candidate given as a booster dose in adults to prevent COVID-19.
This study is seeking participants who are:
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18 through 55 years of age and healthy (who may have preexisting disease if it is stable);
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have received 1 booster dose of a US-authorized COVID-19 vaccine, with the last dose being 90 or more days before the first visit of this study.
All participants in this study will receive 1 of the 2 study vaccines: BNT162b5 Bivalent or BNT162b2 Bivalent. Both vaccines are investigational but are very similar to BNT162b2 (Comirnaty), a COVID-19 RNA vaccine approved for use in the US and in many countries.
All participants will receive a single 30 microgram dose of the study vaccine at the first study clinic and will return to the study clinic 4 more times. At each clinic visit, a blood sample will be taken. They study is about 6 months long for each participant.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BNT162b5 Bivalent (WT/OMI BA.2) Participants will receive 30 µg of BNT162b5 Bivalent (WT/OMI BA.2) at Visit 1. |
Biological: BNT162b5 Bivalent (WT/OMI BA.2)
BNT162b5 Wild Type and BNT162b5 OMICRON [B.1.1.529 sublineage BA.2]
|
| Experimental: BNT162b2 Bivalent (WT/OMI BA.1) Participants will receive 30 µg of BNT162b2 Bivalent (WT/OMI BA.1) at Visit 1. |
Biological: BNT162b2 Bivalent (WT/OMI BA.1)
BNT162b2 Wild Type and BNT162b2 OMICRON [B.1.1.529 sublineage BA.1]
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Percentage of participants reporting adverse events [For 1 month following the study vaccination]
As elicited by the investigational staff
- Percentage of participants reporting serious adverse events [For 6 months following the study vaccination]
As elicited by the investigational staff
- 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 [Before study vaccination (Day 1).]
As measured at the central laboratory.
- Geometric Mean Fold Rise (GMFR) 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 6 months after study vaccination.]
As measured at the central laboratory.
- 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. [Before study vaccination (Day 1).]
As measured at the central laboratory.
- 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 week after study vaccination.]
As measured at the central laboratory.
- 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.
- 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 3 months after study vaccination.]
As measured at the central laboratory.
- 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 6 months after study vaccination.]
As measured at the central laboratory.
- Geometric Mean Fold Rise (GMFR) 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 3 months after study vaccination.]
As measured at the central laboratory.
- Geometric Mean Fold Rise (GMFR) 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.
- Geometric Mean Fold Rise (GMFR) 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 week after study vaccination.]
As measured at the central laboratory.
- 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 week after study vaccination.]
As measured at the central laboratory.
- 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.
- 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 3 months after study vaccination.]
As measured at the central laboratory.
- 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 6 months after study vaccination.]
As measured at the central laboratory.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy participants 18 through 55 years of age (stable pre-existing disease permitted).
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Willing and able to comply with all scheduled visits/contacts, study procedures and lifestyle considerations.
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Capable of giving signed informed consent.
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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.
Exclusion Criteria:
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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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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.
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Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study vaccination or planned receipt throughout the study.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anaheim Clinical Trials, LLC | Anaheim | California | United States | 92801 |
| 2 | Research Centers of America ( Hollywood ) | Hollywood | Florida | United States | 33024 |
| 3 | Clinical Research Atlanta | Stockbridge | Georgia | United States | 30281 |
| 4 | East-West Medical Research Institute | Honolulu | Hawaii | United States | 96814 |
| 5 | Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | United States | 40004 |
| 6 | Accellacare - Wilmington | Wilmington | North Carolina | United States | 28401 |
| 7 | Clinical Neuroscience Solutions, Inc. dba CNS Healthcare | Memphis | Tennessee | United States | 38119 |
| 8 | Benchmark Research | Austin | Texas | United States | 78705 |
| 9 | DM Clinical Research | Tomball | Texas | United States | 77375 |
| 10 | J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | United States | 84121 |
Sponsors and Collaborators
- BioNTech SE
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- C4591044