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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Sep 2020

At a glance

  • Drugs BNT 162 (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man
  • Sponsors BioNTech
  • Most Recent Events

    • 20 Aug 2020 According to a Pfizer, BioNTech AG media release, the companies expect to share T cell immune response data from this trial in the near future.
    • 14 Aug 2020 Planned number of patients changed from 200 to 456.
    • 14 Aug 2020 Planned End Date changed from 1 Aug 2020 to 1 Nov 2020.

Trial Overview

Purpose

The trial has two parts: Part A is for dose ranging with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older subjects. Part B is dedicated to recruit expansion cohorts with dose levels which are selected from data generated in Part A. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen.

Comments

According to a Pfizer media release, the company along with BioNTech SE today announced that two of the company's vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2, received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies ongoing in the United States and Germany as well as animal immunogenicity studies.

Primary Endpoints

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

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

The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE)

description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21±2 days after the prime immunization.
time_frame: 21 days following dose administration

The proportion of subjects with at least 1 unsolicited treatment emergent adverse event (TEAE)

description: For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (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.
time_frame: 28 days following dose administration

Other Endpoints

For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B)

description: Functional antibody responses at 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
time_frame: up to 162 days following dose administration

For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B)

description: Fold increase in functional antibody titers 7±1 days and 21±2 days after primary immunization and at 21±2 days, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
time_frame: up to 162 days following dose administration

For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B)

description: 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, 28±4 days, 63±5 days, and 162±7 days after the boost immunization.
time_frame: up to 162 days following dose administration

For BNT162c2 (SD)

description: Functional antibody responses at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
time_frame: up to 183 days following dose administration

For BNT162c2 (SD)

description: Fold increase in functional antibody titers at 7±1 days, 21±2 days, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
time_frame: up to 183 days following dose administration

For BNT162c2 (SD)

description: 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, 29±3 days, 42±3 days, 84±5 days, and 183±7 days after the primary immunization.
time_frame: up to 183 days following dose administration [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 456

  • Sex male & female
  • Age Group 18-85 years; adult; elderly

Patient 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. - For younger subject cohorts, volunteers must be aged 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. OR For older adult cohorts, volunteers must be aged 56 to 85 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, in the clinical judgment of the investigator, 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 a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 days after receiving the last immunization. WOCBP must agree to require their male partners to use condoms during sexual contact (unless male partners are sterilized or infertile). - 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.

Patient 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 21 continuous days) of any systemic medications, including immunosuppressant's 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 medicinal 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. - Regular receipt of inhaled/nebulized corticosteroids. - For older adults only: Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors: - Hypertension - Diabetes mellitus - Chronic pulmonary disease - Asthma - Chronic liver disease - Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m^2) - Anticipating the need for immunosuppressive treatment within the next 6 months - Resident in a long-term facility - Current vaping or smoking (occasional smoking is acceptable) - History of chronic smoking within the prior year

Trial Details

Identifiers

Identifier Owner
NCT04380701 ClinicalTrials.gov: US National Institutes of Health
EudraCT2020-001038-36 European Clinical Trials Database
U1111-1249-4220 World Health Organisation
BNT162-01 -

Organisations

  • Sponsors BioNTech
  • Affiliations BioNTech; Pfizer; Shanghai Fosun Pharmaceutical

Trial Dates

  • Initiation Dates

    Planned : 30 Apr 2020

    Actual : 23 Apr 2020

  • Primary Completion Dates

    Planned : 01 Nov 2020

  • End Dates

    Planned : 01 Nov 2020

Other Details

  • Design multicentre; open; parallel; prospective; sequential
  • Phase of Trial Phase I/II
  • Location Europe; Germany
  • Focus Adverse reactions; First in man

Interventions

Drugs Route Formulation
BNT 162Primary Drug Intramuscular Injection

BNT162a1 (P/B) - Part A 18-55 years of age

Escalating dose levels Biological: BNT162a1 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162b1 (P/B) - Part A 18-55 years of age

Escalating dose levels Biological: BNT162b1 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162b1 (P/B) - Part A 56-85 years of age

Escalating dose levels Biological: BNT162b1 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162b2 (P/B) - Part A 18-55 years of age

Escalating dose levels Biological: BNT162b2 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162b2 (P/B) - Part A 56-85 years of age

Escalating dose levels Biological: BNT162b2 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162c2 (P/B) - Part A 18-55 years of age

Escalating dose levels Biological: BNT162c2 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162c2 (prime only) - Part A 18-55 years of age

Single dose Biological: BNT162c2 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

Results

Publications

  1. Pfizer, BioNTech. Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
BioNTech 1 - 1
Pfizer 1 1 -

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
BioNTech clinical trial information desk
+49 6131 9084 Ext: 0 info@biontech.de
show details
-
BioNTech clinical trials patient information
+49 6131 9084 Ext: 1919 patients@biontech.de
show details
-
BioNTech Responsible Person BioNTech SE
-
Clinical Study Management
An der Goldgrube 12
Mainz
Postcode: 55131
Germany
Telephone: 0049613190841204
Fax: 004961319084392010
David.Langer@BioNTech.de
show details
BioNTech RNA Pharmaceuticals GmbH Germany

Centres

Centre Name Location Trial Centre Country
-
-
-
BioNTech RNA Pharmaceuticals GmbH Mainz Germany
BioNTech SE
-
-
Contract Research Organization Berlin Germany
Contract Research Organization Mannheim Germany

Trial History

Event Date Event Type Comment
13 Sep 2020 Other trial event Last checked against Clinicaltrials.gov record. Updated 13 Sep 2020
20 Aug 2020 Other trial event According to a Pfizer, BioNTech AG media release, the companies expect to share T cell immune response data from this trial in the near future. Updated 24 Aug 2020
14 Aug 2020 Other trial event Planned number of patients changed from 200 to 456. Updated 19 Aug 2020
14 Aug 2020 Completion date Planned End Date changed from 1 Aug 2020 to 1 Nov 2020. Updated 19 Aug 2020
14 Aug 2020 Other trial event Planned primary completion date changed from 1 Aug 2020 to 1 Nov 2020. Updated 19 Aug 2020
30 Jul 2020 Other trial event Last checked against European Clinical Trials Database. Updated 30 Jul 2020
20 Jul 2020 Other trial event According to a Pfizer media release, preliminary data from both the German and U.S. Phase 1/2 studies, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to an anticipated large, global Phase 2b/3 safety and efficacy trial. Updated 23 Jul 2020
20 Jul 2020 Other trial event According to a Pfizer media release, the new preliminary data from this study support and expand upon the recently disclosed early results from the corresponding U.S. trial with BNT162b1 Updated 23 Jul 2020
20 Jul 2020 Other trial event According to a Pfizer media release, data are undergoing scientific peer-review for potential publication. Updated 23 Jul 2020
20 Jul 2020 Interim results According to a Pfizer media release, preliminary data are available on an online preprint server at medrxiv. Updated 23 Jul 2020
20 Jul 2020 Interim results Preliminary data (n=60 ) presented in a Pfizer Media Release. Updated 23 Jul 2020
13 Jul 2020 Other trial event According to a Pfizer media release, early data from this trial are expected to be released in July 2020. Updated 16 Jul 2020
13 Jul 2020 Other trial event According to a Pfizer media release, the company along with BioNTech SE today announced that two of the company's vaccine candidates from their BNT162 mRNA-based vaccine program (BNT162b1 and BNT162b2) being developed to help protect against SARS-CoV-2, received Fast Track designation from the U.S. Food and Drug Administration (FDA). This designation was granted based on preliminary data from Phase 1/2 studies ongoing in the United States and Germany as well as animal immunogenicity studies. Updated 16 Jul 2020
11 May 2020 Other trial event New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04380701). Updated 11 May 2020
05 May 2020 Other trial event The first subjects immunized in Stage 1 of the study will be healthy adults 18-55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate once testing of that candidate and dose level in younger adults has provided initial evidence of safety and immunogenicity. Updated 07 May 2020
29 Apr 2020 Other trial event According to a BioNTech media release, The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine. Updated 05 May 2020
29 Apr 2020 Other trial event According to a BioNTech media release, BioNTech and Pfizer have announced that the first cohort of this Phase 1/2 clinical trial has been dosed.Twelve study participants were dosed with vaccine candidate BNT162 in Germany since dosing began on April 23, 2020. Updated 05 May 2020
23 Apr 2020 Other trial event Status changed from planning to recruiting. Updated 28 Apr 2020
23 Apr 2020 Other trial event New source identified and integrated(European Clinical Trials Database;EudraCT2020-001038-36). Updated 23 Apr 2020
22 Apr 2020 Other trial event According to a BioNTech media release, the company has received approval from the German regulatory authority, the Paul-Ehrlich-Institut to commence this trial. Updated 27 Apr 2020
22 Apr 2020 Other trial event According to European Clinical Trials Database record trial has been started in Germany. Updated 23 Apr 2020
19 Mar 2020 New trial record New trial record Updated 19 Mar 2020
17 Mar 2020 Other trial event According to a Pfizer media release, Pfizer and BioNTech today announced that the companies have agreed to a letter of intent regarding the co-development and distribution (excluding China) of a potential mRNA-based coronavirus vaccine (BNT162) aimed at preventing COVID-19 infection.The collaboration aims to accelerate global development of BNT162. Updated 20 Mar 2020
17 Mar 2020 Other trial event According to a Pfizer media release, the company expects to start this trial by the end of April 2020. Updated 19 Mar 2020
16 Mar 2020 Other trial event According to a BioNTech media release, as part of its global development program, BioNTech is in advanced discussions with its existing collaborator Pfizer regarding the development of the vaccine outside China. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a BioNTech media release, BioNTech will supply the mRNA vaccine for clinical trials from GMP manufacturing facilities in Europe along with its partner Polymun. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a BioNTech media release, BioNTech and Fosun Pharma announced today a strategic development and commercialization collaboration to advance mRNA vaccine candidate BNT162 in China for the prevention of COVID-19 infections.Under the terms of the agreement, the two companies will work jointly on the development of BNT162 in China.The companies will collaborate to conduct clinical trials in China. Updated 20 Mar 2020
16 Mar 2020 Other trial event According to a BioNTech media release, BioNTech intends to initiate this trial (late April 2020) subject to regulatory approval, as part of a global clinical development program in Europe (commencing in Germany), the United States and China. Updated 20 Mar 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. BioNTech. BioNTech and Pfizer announce regulatory approval from German authority Paul-Ehrlich-Institut to commence first clinical trial of COVID-19 vaccine candidates. Media-Rel 2020;.

    Media Release
  3. Pfizer, BioNTech. Pfizer and BioNTech Announce Early Positive Update from German Phase 1/2 COVID-19 Vaccine Study, Including First T Cell Response Data. Media-Rel 2020;.

    Media Release
  4. European Clinical Trials Database. Trial-Reg 2016;.

    Available from: URL: https://www.clinicaltrialsregister.eu
  5. Pfizer, BioNTech. Pfizer and BioNTech Announce Further Details on Collaboration to Accelerate Global COVID-19 Vaccine Development. Media-Rel 2020;.

    Media Release
  6. Pfizer. Pfizer and BioNTech Dose First Participants in the U.S. as Part of Global COVID-19 mRNA Vaccine Development Program. Media-Rel 2020;.

    Media Release
  7. BioNTech. BioNTech reports rapid progress on COVID-19 vaccine program to address global public health threat. Media-Rel 2020;.

    Media Release
  8. Pfizer. Pfizer and BioNTech to Co-Develop Potential COVID-19 Vaccine. Media-Rel 2020;.

    Media Release
  9. BioNTech, Fosun Pharma. BioNTech and Fosun Pharma form COVID-19 vaccine strategic alliance in China. Media-Rel 2020;.

    Media Release
  10. Pfizer, BioNTech AG. Pfizer and BioNTech Share Positive Early Data on Lead mRNA Vaccine Candidate BNT162b2 Against COVID-19. Media-Rel 2020;.

    Media Release
  11. BioNTech. BioNTech and Pfizer announce completion of dosing for first cohort of Phase 1/2 trial of COVID-19 vaccine candidates in Germany. Media-Rel 2020;.

    Media Release
  12. Pfizer. Pfizer and BioNTech Granted FDA Fast Track Designation for Two Investigational mRNA-based Vaccine Candidates Against SARS-CoV-2. Media-Rel 2020;.

    Media Release
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