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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 and Immunocompromised 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 and Immunocompromised Adults

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 28 Apr 2021

At a glance

  • Drugs BNT 162a1 (Primary) ; BNT 162b1 (Primary) ; BNT 162c2 (Primary) ; Tozinameran (Primary)
  • Indications COVID 2019 infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Sponsors BioNTech
  • Most Recent Events

    • 01 Feb 2021 Planned End Date changed from 1 Nov 2020 to 1 Apr 2023.
    • 01 Feb 2021 Planned primary completion date changed from 1 Nov 2020 to 1 Apr 2023.
    • 14 Dec 2020 According to a BioNTech media release, additional data on neutralizing antibody and T cell responses from this study were published on the preprint server MedRxiv.

Trial Overview

Purpose

This trial has two parts. Part A and Part B. Due to changes in the overall clinical development plan, Part B will no longer be conducted. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). Part A is for dose ranging of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) which will be undertaken with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older participants. 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. Three additional cohorts aged from 18 to 85 years receiving BNT162b2 only. BNT162b2 has entered a Phase II/III evaluation of efficacy, with the intent to support an application for marketing authorization. The dosing regimen under investigation is two BNT162b2 doses given ~21 d apart.

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 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 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 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 days after the boost immunization.
For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 days after the immunization.
time_frame: 28 days following dose administration

immunogenicity

Other Endpoints

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

description: Functional antibody responses (titers) as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 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 as compared to baseline at 7 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 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 and 21 days after primary immunization and at 7, 14, 21, 28, 63, and 162 days after the boost immunization.
time_frame: up to 162 days following dose administration

For BNT162c2 (SD)

description: Functional antibody responses (titers) as compared to baseline at 7, 21, 28, 42, 84, and 183 days after the primary immunization.
time_frame: up to 183 days following dose administration

For BNT162c2 (SD)

description: Fold increase in functional antibody titers as compared to baseline at 7, 21, 28, 42, 84, and 183 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, 21, 28, 42, 84, and 183 days after the primary immunization.
time_frame: up to 183 days following dose administration

For BNT162b2 (P/B)

description: Functional antibody responses (titers) as compared to baseline at 7, 14, and 21 days after the primary immunization and at 7, 28, and 162 days after the boost immunization.
time_frame: up to 162 days following dose administration

For BNT162b2 (P/B)

description: Fold increase in functional antibody titers as compared to baseline at 7, 14, and 21 days after primary immunization and at 7, 28, and 162 days after the boost immunization.
time_frame: up to 162 days following dose administration

For BNT162b2 (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, 14, and 21 days after primary immunization and at 7, 28, and 162 days after the boost immunization.
time_frame: up to 162 days following dose administration [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 618

  • 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 adult cohorts, volunteers must be aged 18 to 55 years, have a body mass index (BMI) 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 BMI over 19 kg/m^2 and under 30 kg/m^2, and weigh at least 50 kg at Visit 0. OR For the immunocompromised adult cohort (Cohort 13), volunteers must be aged 18 to 85 years, have a BMI 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. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. OR For the immunocompromised cohort (Cohort 13); volunteers who have previously received solid organ transplant, or peripheral blood stem cell transplantation ≥6 months after transplantation, or individuals with human immunodeficiency virus (HIV) infection with a CD4+ T-cell count of ≥200 x 10^6 /L at Visit 0. Individuals with lower T-cell counts will be excluded from the trial on the basis that this represents a significant medical complication. In the clinical judgment of the investigator, volunteers must be immunocompromised but otherwise healthy. After consultation with the Medical Monitor, this may include individuals receiving immunosuppressant therapy due to another confounding disease at least 2 weeks prior to enrollment and/or at least 6 weeks following immunization with BNT162b2, and/or individuals with immunosuppressive treatment of an autoimmune disease if the disease is stable. - 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 (except for Cohort 13), 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. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. - Had 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 of active or ongoing hepatitis B or hepatitis C infection; or except for Cohort 13: HIV-1 or HIV-2 infection within the 30 days prior to Visit 0. - Have a positive polymerase chain reaction (PCR)-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. When entering the follow-up phase, i.e., after completing the end of treatment (EoT) visit, subjects are allowed to participate in other clinical trials not investigating COVID-19 vaccines or treatments; subjects immunized with BNT162 vaccines in this clinical trial are allowed to participate in other clinical trials involving immunization with BNT162b2. - 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. - (Except for Cohort 13) 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. - Have 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, volunteers in detention, contract research organization (CRO) or sponsor staff or their family members. - Regular receipt of inhaled/nebulized corticosteroids (except for Cohort 13). - For older volunteers and for Cohort 13 only: Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors: - Uncontrolled hypertension. - Diabetes mellitus (HbA1c >8.5% ≥3 months, according to the medical history reported by the subject). - Chronic obstructive pulmonary disease. - Asthma. - Chronic liver disease. - Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m^2); Except for post-renal transplant patients who should have (estimated) GFR ≥40 mL/min/1.73 m^2. - Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies. - Sickle cell disease. - Cancer (except for Cohort 13). - Are immune compromised due to stem cell or organ-transplantation with significant medical complications such as acute or chronic graft rejection or graft versus host disease requiring intensive immunosuppressive treatment, transplant failure or infectious complications or other conditions that would be considered a contraindication for vaccination. - Are immune compromised due to HIV infection with a CD4+ count of < 200 x 10^6 /L at screening or significant medical complications such as opportunistic infections, malignant complications (e.g., lymphoma, Kaposi sarcoma), other organ manifestations consistent with advanced AIDS or other conditions that would be considered a contraindication for vaccination. - 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

Trial Dates

  • Initiation Dates

    Planned : 30 Apr 2020

    Actual : 23 Apr 2020

  • Primary Completion Dates

    Planned : 01 Apr 2023

  • End Dates

    Planned : 01 Apr 2023

Other Details

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

Interventions

Drugs Route Formulation
BNT 162a1Primary Drug Intramuscular Injection
BNT 162b1Primary Drug Intramuscular Injection
BNT 162c2Primary Drug Intramuscular Injection
TozinameranPrimary 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 18-85 years of age (Expansion cohort 14)

Biomarker (B cell and plasma cell immunity) Biological: BNT162b2 (Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.)

BNT162b2 (P/B) - Part A 18-85 years of age (Expansion cohorts 11 to 13)

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

Immunogenicity

Updated results from phase I/II trial demonstrated combined adaptive humoral and cellular immune response against SARS-CoV-2 and induced T cell immunity. Vaccination with tozinameran showed newly generated spike protein-specific CD4+ T cell responses with almost 92% of participants demonstrated CD8+ T cell responses. Most of the vaccinated participants elicited robust expansion of CD4+ and CD8+ T cells even with lowest dose of 1 µg. Vaccination with tozinameran showed expression of cytokines, interferon and interleukin-2, however demonstrated low levels of interleukin-4 in tozinameran-induced CD4+ T cells indicated a TH1 profile. Tozinameran showed CD8+ T cell response against multiple region of spike proteins and against multiple epitopes of the virus. Induced T cell response was comparable or significantly higher than memory responses of the same individuals against common viruses, such as cytomegalovirus (CMV), Epstein Barr virus (EBV) and the influenza virus. Vaccine also gave protection against pseudo-viruses representing 19 diverse SARS-CoV-2 variants [2] . Earlier results from the trial in patients receiving tozinameran demonstrated strong immunogenicity in younger and older adults. Treatment with tozinameran showed 3.8 times geometric mean titters (GMT) of 38 sera of SARS-CoV2 convalescent patients in younger adult (18-55 years of age) and 1.6 times the GMT of same panel in older adult (65-85 year of age) after 7 days of treatment. In both younger and older adults, BNT162b1 and tozinameran elicited similar dose-dependent SARS-CoV-2–neutralizing antibody GMTs, which were substantially elevated after the second dose, showing clear benefit of a 2-dose regimen. The 50% GMT for BNT 162b2 and BNT 162b1 at the 30µg dose on day 28 or day 35 was 1.7 to 4.6 times for subjects aged 18-55 years, and was 1.1 to 2.2 times for subjects aged 65-85 years, than the GMT of a panel of SARS-CoV-2 human convalescent sera. Although both vaccine candidates elicited lower antigen-binding IgG and neutralizing responses in older adults (65 to 85 years of age), compared to younger adults (18 to 55 years of age), the neutralizing antibody GMTs measured 7 days after Dose 2 of 30µg of BNT162b1 or tozinameran in participants 65 to 85 years old were comparable to or higher than the GMT of a panel of SARS-CoV-2 convalescent sera from 38 patients (18 to 83 years of age) who had contracted SARS-CoV-2. Vaccination with tozinameran in human participants displayed a favorable breadth of epitopes recognised in T cell responses specific to the SARS-CoV-2 spike antigen, as compared to the BNT162b1 candidate. Also, vaccination with tozinameran demonstrated high induction of high CD4+ and CD8+ T cell responses against the receptor binding domain and against the remainder of the spike glycoprotein that is not contained in the BNT162b1 vaccine candidate
[3] .

Results from a phase I/II trial demonstrated that BNT 162b1 elicited receptor binding domain (RBD) binding IgG concentrations after the second dose, compared to baseline. SARS-CoV-2 neutralising geometric mean titers were in the range of 0.7-fold (1 µg) to 3.2-fold (50 µg) compared to that of a panel of SARS-CoV-2 infection convalescent human sera, at day 43. Furthermore, sera of vaccinated subjects displayed broadly neutralising activity in pseudovirus neutralizstion assays across a panel of sixteen SARS-CoV-2 RBD variants represented in publicly available SARS-CoV-2 sequences and against the newly dominant D614G strain. In addition, BNT 162 showed a concurrent induction of high level CD4+ and CD8+ T cell responses against the SARS-CoV-2 RBD. There was no clear dose level dependency of the T cell response between 1µg to 50µg, indicating that stimulation and robust expansion of T cells might be accomplished at low mRNA dose levels. All participants in the prime-boost cohorts, except for two at the lowest dose level, had CD4+ T cell responses. Cytokine profiling of the RBD-specific CD4+ T cells demonstrated a TH1-dominant profile for these cells. During the study, 29 of the 36 tested participants also mounted an RBD-specific functional, CD8+ T cell response that was comparable to memory responses observed against cytomegalovirus (CMV), Epstein Barr virus (EBV) and influenza virus [4] .

Publications

  1. BioNTech. Pfizer and BioNTech Provide Data from German Phase 1/2 Study Further Characterizing Immune Response Following Immunization with Lead COVID-19 Vaccine Candidate BNT162b2. Media-Rel 2020;.

    Media Release
  2. 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
  3. Sahin U, Muik A, Derhovanessian E, Vogler I, Kranz LM, Vormehr M, et al. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. Nature 2020;586(7830):594-599.

    PubMed | CrossRef Fulltext
  4. BioNTech. BioNTech and Pfizer Announce Nature Publication of German Phase 1/2 Study Data from mRNA-based Vaccine Candidate BNT162b1 Against SARS-CoV-2 . Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Baum A 1 - -
Becker D 1 - -
Bexon M 1 - -
BioNTech 3 2 3
Boesler C 1 - -
Bolte S 1 - -
Brachtendorf S 1 - -
Cooper D 1 - -
Cutler M 1 - -
Derhovanessian E 1 - -
Dormitzer PR 1 - -
Eller AK 1 - -
Fischer B 1 - -
Fontes-Garfias C 1 - -
Grutzner J 1 - -
Hilker R 1 - -
Jansen KU 1 - -
Kalina W 1 - -
Kariko K 1 - -
Kemmer-Bruck A 1 - -
Kranz LM 1 - -
Kuhnle MC 1 - -
Kyratsous CA 1 - -
Langer D 1 - -
Lorks V 1 - -
Loschko J 1 - -
Luxemburger U 1 - -
Maurus D 1 - -
Muik A 1 - -
Palanche T 1 - -
Pascal K 1 - -
Perez JL 1 - -
Pfizer 1 1 -
Quandt J 1 - -
Rosenbaum C 1 - -
Sahin U 1 1 -
Schultz A 1 - -
Scully IL 1 - -
Shi PY 1 - -
Sikorski J 1 - -
Swanson KA 1 - -
Tureci O 1 - 1
Vogler I 1 - -
Vormehr M 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 RNA Pharmaceuticals GmbH
-
BioNTech clinical trials patient information
+49 6131 9084 Ext: 1919
patients@biontech.de
show details
, Biontech RNA Pharmaceuticals GmbH
-
Clinical Study Management
An der Goldgrube 12
Mainz
Postcode: 55131
Germany
Telephone: 0049613190847593
Fax: 004961319084392010
Ruben.Rizzi@BioNTech.de
show details
BioNTech RNA Pharmaceuticals GmbH Germany

Centres

Centre Name Location Trial Centre Country
-
-
-
Biontech RNA Pharmaceuticals GmbH
-
-
BioNTech RNA Pharmaceuticals GmbH Mainz Germany
Contract Research Organization Berlin Germany
Contract Research Organization Kiel Germany
Contract Research Organization Mannheim Germany
Universitäts Klinikum Frankfurt am Main Germany
Universitäts Klinikum Heidelberg Germany

Trial History

Event Date Event Type Comment
28 Apr 2021 Other trial event Last checked against ClinicalTrials.gov record. Updated 28 Apr 2021
25 Mar 2021 Other trial event Last checked against European Clinical Trials Database. Updated 25 Mar 2021
01 Feb 2021 Completion date Planned End Date changed from 1 Nov 2020 to 1 Apr 2023. Updated 05 Feb 2021
01 Feb 2021 Other trial event Planned primary completion date changed from 1 Nov 2020 to 1 Apr 2023. Updated 05 Feb 2021
14 Dec 2020 Results According to a BioNTech media release, additional data on neutralizing antibody and T cell responses from this study were published on the preprint server MedRxiv. Updated 21 Dec 2020
14 Dec 2020 Results Results published in the BioNTech Media Release. Updated 21 Dec 2020
20 Oct 2020 Other trial event Planned number of patients changed from 456 to 618. Updated 20 Oct 2020
01 Oct 2020 Interim results Preliminary results (n=60) published in the Nature Updated 10 Nov 2020
30 Sep 2020 Interim results Preliminary Results published in the BioNTech Media Release. Updated 06 Oct 2020
30 Sep 2020 Interim results According to a BioNTech media release, preliminary, peer-reviewed data from this study were published online in the journal Nature. Updated 06 Oct 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 Protocol amendment Number of Treatment arm has increased and older subject also included (age range changed from 18-55 years to 18-85 years) Updated 02 Dec 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
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 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

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