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History of Changes for Study: NCT04380701
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy Adults
Latest version (submitted January 12, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 7, 2020 None (earliest Version on record)
2 May 11, 2020 Contacts/Locations and Study Status
3 August 14, 2020 Arms and Interventions, Study Status, Eligibility, Outcome Measures, Study Design and Study Description
4 September 10, 2020 Study Status and Contacts/Locations
5 February 1, 2021 Study Status, Outcome Measures, Arms and Interventions, Sponsor/Collaborators, Study Identification, Contacts/Locations, Eligibility, Conditions and Study Description
6 April 20, 2021 Arms and Interventions, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Design
7 January 12, 2022 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT04380701
Submitted Date:  May 7, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: BNT162-01
Brief Title: A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-2019 in Healthy Adults
Official Title: A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy Adults
Secondary IDs: 2020-001038-36 [EudraCT Number]
U1111-1249-4220 [WHO UTN]
Open or close this module Study Status
Record Verification: May 2020
Overall Status: Recruiting
Study Start: April 23, 2020
Primary Completion: August 2020 [Anticipated]
Study Completion: August 2020 [Anticipated]
First Submitted: May 6, 2020
First Submitted that
Met QC Criteria:
May 7, 2020
First Posted: May 8, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
May 7, 2020
Last Update Posted: May 8, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: BioNTech RNA Pharmaceuticals GmbH
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The trial has two parts: a dose-finding part (Part A) with four dose cohorts (treatment groups) for each vaccine and one pre-defined and one optional dose level for a de-escalation approach and, a second part (Part B) dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, and BNT162b2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will be administered using a Single dose (SD) regimen.
Detailed Description:
Open or close this module Conditions
Conditions: Infections, Respiratory
Virus Diseases
Infection Viral
Vaccine Adverse Reaction
RNA Virus Infections
Keywords: SARS-CoV-2
Severe Acute Respiratory Syndrome (SARS)
Coronavirus Disease 2019
COVID-2019
Virus Diseases
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Sequential Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: BNT162a1 - Part A
Escalating dose levels
Biological: BNT162a1
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).
Experimental: BNT162b1 - Part A
Escalating dose levels
Biological: BNT162b1
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).
Experimental: BNT162b2 - Part A
Escalating dose levels
Biological: BNT162b2
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).
Experimental: BNT162c2 - Part A
Single dose
Biological: BNT162c2
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime only).
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7±1 days after each immunization.
[ Time Frame: up to 7 days following each dose administration ]

2. Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7±1 days after each immunization.
[ Time Frame: up to 7 days following each dose administration ]

3. The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):
[ Time Frame: 21 days following dose administration ]

For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 21±2 days after the prime immunization.
4. The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE):
[ Time Frame: 28 days following dose administration ]

For BNT162a1, BNT162b1, BNT162b2 (P/B): occurring up to 28±4 days after the boost immunization.

For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28±4 days after the immunization.

Secondary Outcome Measures:
1. For BNT162a1, BNT162b1, BNT162b2 (P/B):
[ Time Frame: up to 162 days following dose administration ]

Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
2. For BNT162a1, BNT162b1, BNT162b2 (P/B):
[ Time Frame: up to 162 days following dose administration ]

Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
3. For BNT162a1, BNT162b1, BNT162b2 (P/B):
[ Time Frame: up to 162 days following dose administration ]

Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 63±5 days, and 162±7 days after the boost immunization.
4. For BNT162c2 (SD):
[ Time Frame: up to 183 days following dose administration ]

Functional antibody responses at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
5. For BNT162c2 (SD):
[ Time Frame: up to 183 days following dose administration ]

Fold increase in functional antibody titers at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
6. For BNT162c2 (SD):
[ Time Frame: up to 183 days following dose administration ]

Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers as compared to baseline at 7±1 days, 21±2 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 55 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
  • They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial.
  • They must be able to understand and follow trial-related instructions.
  • They must be aged from 18 to 55 years, have a body mass index over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0.
  • They must be healthy based on medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at Visit 0.
  • Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential.
  • WOCBP must agree to practice two highly effective forms of contraception during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • WOCBP must confirm that they practice at least one highly effective form of contraception for the 14 days prior to Visit 0.
  • WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 days after receiving the last immunization.
  • They must have confirmation of their health insurance coverage prior to Visit 0.
  • They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 days after receiving the last immunization.

Exclusion Criteria:

  • Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the first immunization. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
  • Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization.
  • Have a known allergy, hypersensitivity, or intolerance to the planned investigational medicinal product (IMP) including any excipients of the IMP.
  • Had any medical condition or any major surgery (e.g., requiring general anesthesia) within the past 5 years which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
  • Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 days after receiving the last immunization.
  • Had any chronic use (more than 14 continuous days) of any systemic medications, including immunosuppressant or other immune-modifying drugs, within the 6 months prior to Visit 0 unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise subject safety.
  • Received any vaccination within the 28 days prior to Visit 0.
  • Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0.
  • Had administration of another investigational product including vaccines within 60 days or 5 half-lives (whichever is longer), prior to Visit 0.
  • Have a known history or a positive test of any of human immunodeficiency virus (HIV) 1 or 2, Hepatitis B, or Hepatitis C, within the 30 days prior to Visit 0.
  • Have a positive polymerase chain reaction-based test for SARS-CoV-2 within the 30 days prior to Visit 1.
  • Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or Visit 1.
  • Have a positive breath alcohol test at Visit 0 or Visit 1.
  • Previously participated in an investigational trial involving lipid nanoparticles.
  • Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial.
  • Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site).
  • Have a history (within the past 5 years) of substance abuse or known medical, psychological, or social conditions which, in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
  • Have a history of hypersensitivity or serious reactions to previous vaccinations.
  • Have a history of Guillain-Barré Syndrome within 6 weeks following a previous vaccination.
  • Have a history of narcolepsy.
  • Have history of alcohol abuse or drug addiction within 1 year before Visit 0.
  • Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0.
  • Have any abnormality or permanent body art (e.g., tattoo) that, in the opinion of the investigator, would obstruct the ability to observe local reactions at the injection site.
  • Have had any blood loss >450 mL, e.g., due to donation of blood or blood products or injury, within the 7 days prior to Visit 0 or plan to donate blood during the trial, starting after Visit 0 and continuously until at least 7 days after receiving the last immunization.
  • Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties.
  • Have had contact with persons diagnosed with COVID-19 or who tested positive for SARS-CoV-2 by any diagnostic test within the 30 days prior to Visit 1.
  • Are soldiers, subjects in detention, contract research organization (CRO) or sponsor staff or their family members.
Open or close this module Contacts/Locations
Central Contact Person: BioNTech clinical trials patient information
Telephone: +49 6131 9084 Ext. 1919
Email: patients@biontech.de
Central Contact Backup: BioNTech clinical trial information desk
Telephone: +49 6131 9084 Ext. 0
Email: info@biontech.de
Study Officials: BioNTech Responsible Person
Study Director
BioNTech SE
Locations: Germany
CRS Clinical Research Services Berlin GmbH
[Recruiting]
Berlin, Germany, 13353
CRS Clinical Research Services Mannheim GmbH
[Recruiting]
Mannheim, Germany, 68167
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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