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    Summary
    EudraCT Number:2020-003267-26
    Sponsor's Protocol Code Number:BNT162-04
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-07-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2020-003267-26
    A.3Full title of the trial
    A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of a prophylactic SARS-CoV-2 RNA vaccine (BNT162b3) against COVID-19 using different dosing regimens in healthy adults
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the safety and effects of a vaccine in healthy adults.
    A.3.2Name or abbreviated title of the trial where available
    Phase I/II Trial Investigating the Safety and Effects of a BNT162 Vaccine Against COVID-19
    A.4.1Sponsor's protocol code numberBNT162-04
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1254-4840
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioNTech SE
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBioNTech SE
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioNTech SE
    B.5.2Functional name of contact pointClinical Study Management
    B.5.3 Address:
    B.5.3.1Street AddressAn der Goldgrube 12
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number0049613190841204
    B.5.5Fax number004961319084 392010
    B.5.6E-mailBNT162-010414@biontech.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBNT162b3
    D.3.2Product code RBP020.8
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Protection against COVID-19
    E.1.1.1Medical condition in easily understood language
    Healthy volunteers (prevention of infection with the Corona virus)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10051905
    E.1.2Term Coronavirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the safety and tolerability profile of a prophylactic BNT162 vaccine in healthy adults after prime/boost (P/B) immunization.
    E.2.2Secondary objectives of the trial
    To describe the immune response in healthy adults after P/B immunization measured by a functional antibody titer, e.g., virus neutralization test (VNT) or an equivalent assay available by the time of trial conduct.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
    2. 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.
    3. They must be able to understand and follow trial-related instructions.
    4. For younger subject cohorts, volunteers must be aged 18 to 55 years, have a body mass index over 19 kg/m2 and under 30 kg/m2, 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/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.
    5. They must be healthy based on medical history, physical examination, 12-lead 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.
    6. 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.
    7. WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
    8. WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0.
    9. 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 d after receiving the last immunization.
    10. 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 d after receiving the last immunization.
    11. Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until 60 d after receiving the last immunization.
    12. They must have confirmation of their health insurance coverage prior to Visit 0.
    13. They must agree to not be vaccinated during the trial, starting after Visit 0 and continuously until 28 d after receiving the last immunization.
    E.4Principal exclusion criteria
    • Have had any acute illness, as determined by the investigator, with or without fever, within 72 h prior to any 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 wellbeing if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
    • Have a known allergy, hypersensitivity, or intolerance to the planned 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 wellbeing 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 d after receiving the last immunization.
    • Had any chronic use (more than 21 continuous days) of any systemic medications, including immunosuppressants 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.
    • 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 wks before enrollment, can be included.
    • Regular receipt of inhaled/nebulized corticosteroids.
    • Had any vaccination within the 28 d 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 IMP including vaccines within 60 d 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 d prior to Visit 0.
    • Have a positive PCR-based test for SARS-CoV-2 within the 30 d prior to Visit 1.
    • Previously participated in an investigational trial involving lipid nanoparticles.
    • 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 wellbeing 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 wks following a previous vaccination.
    • Have a history of narcolepsy.
    • Have a history of or suspected immunosuppressive condition, acquired or congenital, as determined by medical history and/or physical examination at Visit 0.
    • Have symptoms of the Coronavirus Disease 2019 (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 d prior to Visit 1.
    • Are soldiers, persons in detention, CRO or sponsor staff or their family members.
    • Have a condition known to put them at high risk for severe COVID-19, including those with any of the following risk factors:
    o Cancer
    o COPD (chronic obstructive pulmonary disease)
    o Immunocompromised state (weakened immune system) from solid organ transplant
    o Obesity (BMI of 30 or higher)
    o Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
    o Sickle cell disease
    o Diabetes mellitus
    o Hypertension
    o Asthma
    o Chronic liver disease
    o Known Stage 3 or worse chronic kidney disease (glomerular filtration rate <60 mL/min/1.73 m2)
    o Anticipating the need for immunosuppressive treatment within the next 6 months
    o Resident in a long-term facility
    o Current vaping or smoking (occasional smoking is acceptable)
    o History of chronic smoking within the prior year
    E.5 End points
    E.5.1Primary end point(s)
    - Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7 d after each immunization.
    - Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 d after each immunization.
    - The proportion of subjects with at least 1 unsolicited TEAE occurring after prime immunization up to boost immunization or 28 d after prime immunization (whichever comes first) and up to 28 d after the boost immunization.
    E.5.1.1Timepoint(s) of evaluation of this end point
    see Clinical Trial Protocol, Section 9.4.2 Primary endpoints
    E.5.2Secondary end point(s)
    As compared to baseline, at 7 d and 21 d after prime immunization and at 7 d, 14 d, 21 d, 28 d, 63 d, 162 d, and 365 d after the boost immunization:
    • Functional antibody responses.
    • Fold increase in functional antibody titers.
    • Number of subjects with seroconversion defined as a minimum of 4-fold increase of functional antibody titers
    E.5.2.1Timepoint(s) of evaluation of this end point
    see Clinical Trial Protocol, Section 9.4.3 Secondary endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II, Dose-Escalation Trial
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Part A: dose-escalation design
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit (LSLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 32
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    healthy adults aged 56 to 85
    F.4 Planned number of subjects to be included
    F.4.1In the member state96
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No plans since healthy subjects
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-02-07
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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