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

Sponsor
BioNTech SE (Industry)
Overall Status
Completed
CT.gov ID
NCT04816669
Collaborator
Pfizer (Industry)
629
Enrollment
21
Locations
5
Arms
8
Actual Duration (Months)
30
Patients Per Site
3.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: BNT162b2
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
629 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Dec 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: Lyophilized SDV

Biological: BNT162b2
Intramuscular injection

Experimental: Frozen liquid MDV (control for lyo SDV)

Control for lyophilized SDV

Biological: BNT162b2
Intramuscular injection

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

Biological: BNT162b2
Intramuscular injection

Experimental: RTU

Biological: BNT162b2
Intramuscular injection

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

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

Biological: BNT162b2
Intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Geometric mean ratio of lyophilized BNT162b2 in single-dose vials is noninferior to frozen-liquid BNT162b2 in multi-dose vials in participants without evidence of SARS-CoV-2 infection [1 month after Dose 2]

    As measured at the central laboratory

  2. Percentage of participants reporting local reactions [For 7 days after Dose 1 and Dose 2]

    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries

  3. Percentage of participants reporting systemic events [For 7 days after Dose 1 and Dose 2]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries

  4. Percentage of participants reporting adverse events [From Dose 1 through 1 month after Dose 2]

    As elicited by investigational site staff

  5. Percentage of participants reporting serious adverse events [From Dose 1 through 1 month after Dose 2]

    As elicited by investigational site staff

Secondary Outcome Measures

  1. Geometric mean concentration of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with lyophilized BNT162b2 in single-dose vials and frozen-liquid BNT162b2 in multi-dose vials [At baseline (before Dose 1) and at 1 month after Dose 2]

    As measured at the central laboratory

  2. Geometric mean fold rise of SARS-CoV-2 full-length S-binding antibody levels in participants vaccinated with lyophilized BNT162b2 in single-dose vials and frozen-liquid BNT162b2 in multi-dose vials [From baseline (before Dose 1) to 1 month after Dose 2]

    As measured at the central laboratory

Other Outcome Measures

  1. Geometric mean ratio of frozen-liquid BNT162b2 with LNP size at the upper end of specification to frozen-liquid BNT162b2 in multi-dose vials in participants without evidence of SARS-CoV-2 infection [1 month after Dose 2]

    As measured at the central laboratory

  2. Geometric mean concentrations of SARS-CoV-2 full-length S-binding antibody levels and/or geometric mean titers of SARS-CoV-2 neutralizing titers in participants receiving BNT162b2 with LNP size at the upper end of specification and RTU BNT162b2 [At baseline (before Dose 1) and 1 month after Dose 2]

    As measured at the central laboratory

  3. Geometric mean fold rise of SARS-CoV-2 full-length S-binding antibody levels and/or SARS-CoV-2 neutralizing titers in participants receiving BNT162b2 with LNP size at the upper end of specification and RTU BNT162b2 [From baseline (before Dose 1) and 1 month after Dose 2]

    As measured at the central laboratory

  4. Percentage of participants reporting local reactions following frozen-liquid BNT162b2 formulation when given as third dose following a primary series of lyophilized BNT162b2 [For 7 days after Dose 3]

    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries

  5. Percentage of participants reporting systemic events following frozen-liquid BNT162b2 formulation when given as third dose following a primary series of lyophilized BNT162b2 [For 7 days after Dose 3]

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries

  6. Percentage of participants reporting adverse events following frozen-liquid BNT162b2 formulation when given as third dose following a primary series of lyophilized BNT162b2 [From Dose 3 through 1 month after Dose 3]

    As elicited by investigational site staff

  7. Percentage of participants reporting serious adverse events following frozen-liquid BNT162b2 formulation when given as third dose following a primary series of lyophilized BNT162b2 [From Dose 3 through 1 month after Dose 3]

    As elicited by investigational site staff

  8. Geometric mean fold rise of SARS-CoV-2 full-length S-binding antibody levels and/or SARS-CoV-2 neutralizing titers in participants receiving frozen-liquid BNT162b2 formulation given as third dose following a primary series of lyophilized BNT162b2 [Prior to Dose 3 to 1 month after Dose 3]

    As measured at the central laboratory

  9. Geometric mean concentrations of SARS-CoV-2 full-length S-binding AB levels and/or geometric mean titers of SARS-CoV-2 neutralizing titers in participants receiving frozen-liquid formulation given as third dose following a primary series of lyo BNT162b2 [At baseline, at 1 month after Dose 2, prior to Dose 3 and 1 month after Dose 3]

    As measured at the central laboratory

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

  • 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. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.

  • 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.

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(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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Anaheim Clinical Trials, LLCAnaheimCaliforniaUnited States92801
2Diablo Clinical Research, Inc.Walnut CreekCaliforniaUnited States94598
3Indago Research & Health Center, IncHialeahFloridaUnited States33012
4Research Centers of America ( Hollywood )HollywoodFloridaUnited States33024
5Clinical Neuroscience Solutions, Inc. dba CNS HealthcareJacksonvilleFloridaUnited States32256
6Clinical Neuroscience SolutionsOrlandoFloridaUnited States32801
7Clinical Research AtlantaStockbridgeGeorgiaUnited States30281
8East-West Medical Research InstituteHonoluluHawaiiUnited States96814
9Solaris Clinical ResearchMeridianIdahoUnited States83646
10Kentucky Pediatric/ Adult ResearchBardstownKentuckyUnited States40004
11Meridian Clinical Research, LLCOmahaNebraskaUnited States68134
12Amici Clinical Research LLCRaritanNew JerseyUnited States08869
13Accellacare (formerly PMG Research of Wilmington, LLC)WilmingtonNorth CarolinaUnited States28401
14Aventiv Research IncColumbusOhioUnited States43213
15Benchmark ResearchAustinTexasUnited States78705
16University of Texas Medical BranchGalvestonTexasUnited States77555
17Texas Center for Drug Development, Inc.HoustonTexasUnited States77081
18DM Clinical Research (Administrative and Storage Office only)TomballTexasUnited States77375
19Martin Diagnostic ClinicTomballTexasUnited States77375
20J. Lewis Research, Inc. / Foothill Family ClinicSalt Lake CityUtahUnited States84109
21J. Lewis Research, Inc. / Foothill Family Clinic SouthSalt Lake CityUtahUnited States84121

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.
Responsible Party:
BioNTech SE
ClinicalTrials.gov Identifier:
NCT04816669
Other Study ID Numbers:
  • C4591020
First Posted:
Mar 25, 2021
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by BioNTech SE
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022