Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04816669
Recruitment Status : Active, not recruiting
First Posted : March 25, 2021
Last Update Posted : August 11, 2021
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
BioNTech SE

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).

  • 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 disease Intervention/treatment Phase
SARS-CoV-2 Infection COVID-19 Biological: BNT162b2 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 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 : April 1, 2021
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Arm Intervention/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




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 [ Time Frame: 1 month after Dose 2 ]
    As measured at the central laboratory

  2. Percentage of participants reporting local reactions [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From Dose 1 through 1 month after Dose 2 ]
    As elicited by investigational site staff

  5. Percentage of participants reporting serious adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month after Dose 2 ]
    As measured at the central laboratory

  2. Geometric mean ratio of RTU formulation to lyophilized formulation in single-dose vials 1 month after Dose 2 in participants without evidence of SARS-CoV-2 infection [ Time Frame: 1 month after Dose 2 ]
    As measure at the central laboratory

  3. 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 [ Time Frame: At baseline (before Dose 1) and 1 month after Dose 2 ]
    As measured at the central laboratory

  4. 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 [ Time Frame: From baseline (before Dose 1) and 1 month after Dose 2 ]
    As measured at the central laboratory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04816669


Locations
Show Show 21 study locations
Sponsors and Collaborators
BioNTech SE
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04816669    
Other Study ID Numbers: C4591020
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioNTech SE:
COVID-19
Coronavirus
Vaccine
SARS-CoV-2
RNA Vaccine