Protection against COVID-19 MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: BNT162b3
Product Code: RBP020.8
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
BioNTech SE
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 64 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the safety and tolerability profile of a prophylactic BNT162 vaccine in healthy adults after prime/boost (P/B) immunization.;Secondary Objective: 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.;Primary 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.;Timepoint(s) of evaluation of this end point: see Clinical Trial Protocol, Section 9.4.2 Primary endpoints | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(s) of evaluation of this end point: see Clinical Trial Protocol, Section 9.4.3 Secondary endpoints | — |
Countries
Germany
Contacts
Public ContactClinical Study Management
BioNTech SE
Outcome results
None listed