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

BioNTech

Status and phase: Completed; Phase 3

Conditions: COVID-19; SARS-CoV-2 Infection

Treatments: Biological: BNT162b2; Biological: BNT162b2.B.1.351

Study type: Interventional

Funder types: Industry

Identifiers

NCT04713553

C4591017

Details and patient eligibility

About

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):

• As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)
• As a 20-microgram dose, administered from 1 of the manufacturing lots
• As a 2-dose (separated by 21 days) schedule
• 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):

• Each as a 30-microgram dose
• Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2
• In people 18 through 50 years of age

Enrollment: 1,574 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary study: Male or female participants between the ages of 12 and 50 years, inclusive, at randomization.
• Booster study: Male or female participants between the ages of 18 and 50 years, inclusive, at rerandomization.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• 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.
• Capable of giving personal signed informed consent/have parent(s)/legal guardian capable of giving signed informed consent.

Exclusion criteria

• 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.

• Known infection with HIV, HCV, or HBV.

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.

• 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.

• 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.

• Primary study: Previous vaccination with any coronavirus vaccine.

• Booster study: Previous vaccination with any coronavirus vaccine outside of this study.

• Receipt of medications intended to prevent COVID-19.

• 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.

• Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.

• Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.

• Previous participation in other studies involving study intervention containing lipid nanoparticles.

• 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:

• Current febrile illness (body temperature ≥100.4°F [≥38.0°C]) or other acute illness within 48 hours before study intervention administration.
• 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.
• Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,574 participants in 7 patient groups

Arm 1

Experimental group

Description:

30-microgram dose of US manufactured drug substance (Lot 1)

Treatment:

Biological: BNT162b2

Arm 2

Experimental group

Description:

30-microgram dose of US manufactured drug substance (Lot 2)

Treatment:

Biological: BNT162b2

Arm 3

Experimental group

Description:

30-microgram dose of US manufactured drug substance (Lot 3)

Treatment:

Biological: BNT162b2

Arm 4

Experimental group

Description:

30-microgram dose of EU manufactured drug substance (Lot 4)

Treatment:

Biological: BNT162b2

Arm 5

Experimental group

Description:

20-microgram dose of US manufactured drug substance (corresponding to Arm 1, 2 or 3 lot)

Treatment:

Biological: BNT162b2

Booster 1: BNT162b2

Experimental group

Description:

30-microgram dose

Treatment:

Biological: BNT162b2

Booster 2: BNT162b2.B.1.351

Experimental group

Description:

30-microgram dose

Treatment:

Biological: BNT162b2.B.1.351