A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Study Details
Study Description
Brief Summary
This is a Phase 3, randomized, observer-blind study in healthy individuals.
The primary study will evaluate the safety, tolerability, and immunogenicity of the
SARS-CoV-2 RNA vaccine candidate (BNT162b2):
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As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
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As a 20-microgram dose, administered from 1 of the manufacturing lots
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As a 2-dose (separated by 21 days) schedule
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In people 12 through 50 years of age
The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2
RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):
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Each as a 30-microgram dose
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Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2
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In people 18 through 50 years of age
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm 1 30-microgram dose of US manufactured drug substance (Lot 1) |
Biological: BNT162b2
Intramuscular injection
|
Experimental: Arm 2 30-microgram dose of US manufactured drug substance (Lot 2) |
Biological: BNT162b2
Intramuscular injection
|
Experimental: Arm 3 30-microgram dose of US manufactured drug substance (Lot 3) |
Biological: BNT162b2
Intramuscular injection
|
Experimental: Arm 4 30-microgram dose of EU manufactured drug substance (Lot 4) |
Biological: BNT162b2
Intramuscular injection
|
Experimental: Arm 5 20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot) |
Biological: BNT162b2
Intramuscular injection
|
Experimental: Booster 1: BNT162b2 30-microgram dose |
Biological: BNT162b2
Intramuscular injection
|
Experimental: Booster 2: BNT162b2.B.1.351 30-microgram dose |
Biological: BNT162b2.B.1.351
Intramuscular injection
|
Outcome Measures
Primary Outcome Measures
- Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-binding antibody levels between US lots (Arms 1, 2 and 3) in participants without evidence of infection during the study [At 1 month after Dose 2]
As measured at the central laboratory
- GMR of SARS-CoV-2 full-length S-binding antibody levels between the EU lot (Arm 4) and pooled US lots (Arms 1, 2, and 3) in participants without evidence of infection during the study [At 1 month after Dose 2]
As measured at the central laboratory
- GMR of SARS-CoV-2 neutralizing antibody levels between the 20-microgram dose group (Arm 5) and the corresponding 30-microgram dose group (Arm 1, 2, or 3) in participants without evidence of SARS-C0V-2 infection during the study. [At 1 month after Dose 2]
As measured at the central laboratory
- Percentage of participants reporting local reactions [For 7 days after Dose 1 and Dose 2. For 7 days after Dose 3 (booster).]
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
- Percentage of participants reporting systemic events [For 7 days after Dose 1 and Dose 2. For 7 days after Dose 3 (booster).]
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 [From Dose 1 through 1 month after Dose 2. From Dose 3 to 1 month after Dose 3.]
As elicited by investigational site staff
- Percentage of participants reporting serious adverse events [From Dose 1 through 1 month after Dose 2. From Dose 3 to 1 month after Dose 3.]
As elicited by investigational site staff
- Geometric Mean Titers (GMT) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [Before Dose 1, 1 month after Dose 2, before Dose 3, and 1 week after and 1 month after Dose 3.]
As measured at the central laboratory
- Geometric Mean IgG Concentrations (GMC) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [Before Dose 1, 1 month after Dose 2, before Dose 3, and 1 week after and 1 month after Dose 3.]
As measured at the central laboratory
- Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [From 1 month after Dose 2 to 1 week after and 1 month after Dose 3 and from before Dose 3 to 1 week after and 1 month after Dose 3.]
As measured at the central laboratory
- Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351). [From 1 month after Dose 2 to 1 week after and 1 month after Dose 3 and from before Dose 3 to 1 week after and 1 month after Dose 3.]
As measured at the central laboratory
- Percentages of participants with seroresponse (based on neutralizing titers) to the reference strain. [At 1 month after Sode 2, before Dose 3, and 1 week after and 1 month after Dose 3.]
As measured at the central laboratory
- Percentages of participants with seroresponse (based on neutralizing titers) to the B.1.351 strain. [At 1 month after Sode 2, before Dose 3, and 1 week after and 1 month after Dose 3.]
As measured at the central laboratory
Secondary Outcome Measures
- Geometric Mean Concentrations (GMCs) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with one of the 30-microgram lots (US or EU). [At baseline (before Dose 1) and at 1 month after Dose 2]
As measured at the central laboratory
- Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with one of the 30-microgram lots (US or EU) [From baseline (before Dose 1) to 1 month after Dose 2]
As measured at the central laboratory
- GMTs of SARS CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot) [At baseline (before Dose 1) and 1 month after Dose 2]
As measured at the central laboratory
- GMFRs of SARS-CoV-2 neutralizing antibody levels in participants vaccinated with the 20-microgram or 30-microgram dose (from same US lot). [From baseline (before Dose 1) to 1 month after Dose 2]
As measured at the central laboratory
Eligibility Criteria
Criteria
Inclusion Criteria:
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Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
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Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
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Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
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Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
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Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.
Exclusion Criteria:
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Other 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.
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Known infection with HIV, HCV, or HBV.
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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 intervention.
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Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
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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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Primary study: Previous vaccination with any coronavirus vaccine.
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Booster study: Previous vaccination with any coronavirus vaccine outside of this study.
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Receipt of medications intended to prevent COVID-19.
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Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
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Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
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Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
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Previous participation in other studies involving study intervention containing lipid nanoparticles.
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Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Additional Exclusion Criteria for the Booster study:
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Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
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Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other nonstudy vaccine within 28 days, before or after study intervention administration.
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Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Kaiser Permanente Oakland | Oakland | California | United States | 94611 |
2 | Clinical Research Consulting | Milford | Connecticut | United States | 06460 |
3 | Indago Research & Health Center, Inc | Hialeah | Florida | United States | 33012 |
4 | Research Centers of America | Hollywood | Florida | United States | 33024 |
5 | Clinical Neuroscience Solutions | Orlando | Florida | United States | 32801 |
6 | Clinical Research Atlanta | Stockbridge | Georgia | United States | 30281 |
7 | East-West Medical Research Institute | Honolulu | Hawaii | United States | 96814 |
8 | Solaris Clinical Research | Meridian | Idaho | United States | 83646 |
9 | Kentucky Pediatric/Adult Research | Bardstown | Kentucky | United States | 40004 |
10 | Amici Clinical Research LLC | Raritan | New Jersey | United States | 08869 |
11 | Accellacare - Wilmington | Wilmington | North Carolina | United States | 28401 |
12 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45206 |
13 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229-3039 |
14 | Texas Center for Drug Development, Inc. | Houston | Texas | United States | 77081 |
15 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
16 | Martin Diagnostic Clinic | Tomball | Texas | United States | 77375 |
17 | 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.- C4591017