Clinical trial NCT04816669: A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2 Infection
COVID-19
Keywords: COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine
Lead sponsor: BioNTech SE
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2021-03-25
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 Month after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 1
timeFrame: Within 7 days after Dose 1
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 2
timeFrame: Within 7 days after Dose 2
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Dose 1 to 1 Month After Dose 2
timeFrame: Dose 1 up to 1 Month after Dose 2 (for approximately 2 months)
Secondary outcomes:
measure: Geometric Mean Concentrations (GMCs) of Full-length S-binding IgG Levels at Baseline: Part 1
timeFrame: Baseline (Before Dose 1 on Day 1)
measure: Geometric Mean Fold Rises (GMFRs) in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 1
timeFrame: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2
Other outcomes:
measure: 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
timeFrame: 1 Month after Dose 2
measure: GMCs of Full-length S-binding IgG Levels at Baseline and 1 Month After Dose 2: Part 2
timeFrame: Baseline (Before Dose 1 on Day 1), 1 Month after Dose 2
measure: GMFRs in Full-length S-binding IgG Levels From Baseline to 1 Month After Dose 2: Part 2
timeFrame: From Baseline (Before Dose 1 on Day 1) up to 1 Month after Dose 2
measure: Percentage of Participants With Local Reactions Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3
measure: Percentage of Participants With Systemic Events Within 7 Days After Dose 3
timeFrame: Within 7 days after Dose 3
measure: Number of Participants With AEs and SAEs From Dose 3 to 1 Month After Dose 3
timeFrame: Dose 3 up to 1 Month after Dose 3 (1 month)
measure: GMFRs in Full-length S-binding IgG Levels From Before Dose 3 to 1 Month After Dose 3
timeFrame: From before Dose 3 to 1 Month after Dose 3
measure: GMCs of Full-Length S-Binding IgG Levels at Baseline, 1 Month After Dose 2, Before Dose 3, and 1 Month After Dose 3
timeFrame: Baseline, 1 Month after Dose 2, before Dose 3, and 1 Month after Dose 3
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials, LLC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood )
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Bardstown
country: United States
facility: Kentucky Pediatric/ Adult Research
state: Kentucky
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Raritan
country: United States
facility: Amici Clinical Research LLC
state: New Jersey
city: Wilmington
country: United States
facility: Accellacare (formerly PMG Research of Wilmington, LLC)
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, Inc.
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research (Administrative and Storage Office only)
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: