A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

NCT04816669 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: C4591020
• Study Type: interventional
• Target: 629
• Locations: 1 country
• Sites: 21

Brief Summary

This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate). Additionally, the study will describe the safety and immunogenicity of an additional dose of frozen liquid BNT162b2 to participants who already received the 2-dose schedule of lyophilized BNT162b2.

• 2-dose schedule (separated by 21 days)
• At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
• In healthy adults 18 through 55 years of age
• The duration of the study for each participant will be approximately 2 months (3 visits in total)
• The study will be conducted in the United States

Conditions

SARS-CoV-2 Infection; COVID-19

Keywords

COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine

Outcome Measures

Primary Outcomes (6)

• Geometric Mean Titers (GMTs) of Full-Length S-Binding IgG Concentrations of Lyophilized Formulation SDVs and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2

  GMTs of full-length S-binding IgG level for lyophilized formulation in SDVs and frozen-Liquid formulation in MDVs were reported in this outcome measure as geometric mean concentration (GMCs) in descriptive data section. GMC and 95 percent (%) confidence interval (CI) were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was calculated as ratios of GMCs of BNT162b2 30 mcg lyophilized SDV and frozen-liquid MDV. GMR are reported in the statistical analysis section.

  1 Month after Dose 2

• Percentage of Participants With Local Reactions Within 7 Days After Dose 1

  Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.

  Within 7 days after Dose 1

• Percentage of Participants With Local Reactions Within 7 Days After Dose 2

  Local reactions were collected by the participant using an electronic diary. Local reactions included redness, swelling, and pain at injection site after each vaccination.

  Within 7 days after Dose 2

• Percentage of Participants With Systemic Events Within 7 Days After Dose 1

  Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree Celsius (C). Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 1 were reported.

  Within 7 days after Dose 1

• Percentage of Participants With Systemic Events Within 7 Days After Dose 2

  Systemic events were reported using an electronic diary. Fever was defined as temperature \>=38.0 degree C. Systemic events including fever, fatigue, headache, chills, new or worsened muscle pain, new or worsened joint pain, vomiting, and diarrhea after Dose 2 were reported.

  Within 7 days after Dose 2

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect or that was considered to be an important medical event. AEs included all non-SAEs and SAEs. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)

Secondary Outcomes (2)

• Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1

  Baseline (Before Dose 1 on Day 1)

• Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1

  From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2

Other Outcomes (8)

• GMTs of Full-Length S-Binding IgG Concentrations of Frozen Liquid With LNP Size at Upper End of Specification and Frozen-Liquid Formulation in MDVs 1 Month After Dose 2

  1 Month after Dose 2

• GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2

  Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2

• GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2

  From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2

Study Arms (5)

Lyophilized SDV

EXPERIMENTAL

Biological: BNT162b2

Frozen liquid MDV (control for lyo SDV)

EXPERIMENTAL

Control for lyophilized SDV

Biological: BNT162b2

Frozen-liquid with LNP size at the upper end of specification

EXPERIMENTAL

Biological: BNT162b2

RTU

EXPERIMENTAL

Biological: BNT162b2

Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2)

EXPERIMENTAL

Additional vaccine dose, using the frozen-liquid formulation, offered to participants who originally received 2 doses of the lyophilized formulation of BNT162b2

Biological: BNT162b2

Interventions

BNT162b2 BIOLOGICAL

Intramuscular injection

Frozen liquid MDV (control for lyo SDV); Frozen liquid MDV (given as third dose following a primary series of lyophilized BNT162b2); Frozen-liquid with LNP size at the upper end of specification; Lyophilized SDV; RTU

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.
• For Dose 3: Participants who received BOTH doses of the lyophilized formulation of BNT162b2 as part of the initial study.

You may not qualify if:

• 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(s).
• 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.
• Previous vaccination with any coronavirus vaccine.
• Receipt of medications intended to prevent COVID-19.
• Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• 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 (LNPs).
• 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.

Sponsors & Collaborators

• BioNTech SE: lead
• Pfizer: collaborator

Study Sites (21)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Research Centers of America ( Hollywood )

Hollywood, Florida, 33024, United States

Location

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Amici Clinical Research LLC

Raritan, New Jersey, 08869, United States

Location

Accellacare (formerly PMG Research of Wilmington, LLC)

Wilmington, North Carolina, 28401, United States

Location

Aventiv Research Inc

Columbus, Ohio, 43213, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

DM Clinical Research (Administrative and Storage Office only)

Tomball, Texas, 77375, United States

Location

Martin Diagnostic Clinic

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: BioNTech clinical trials patient information
• Organization: BioNTech SE

patients@biontech.de

+49 6131 9084

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 25, 2021
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 2, 2021
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)