A Phase II trial to evaluate the safety and immunogenicity of SARS-CoV-2 monovalent and multivalent RNA-based vaccines in healthy subjects

BioNTech SE0 sites1,470 target enrollmentAugust 13, 2021

ConditionsProtection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2).MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 23.0Level: HLTClassification code 10084510Term: Coronavirus infectionsSystem Organ Class: 10021881 - Infections and infestations MedDRA version: 23.1Level: LLTClassification code 10084529Term: 2019 novel coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Protection against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV 2).
Sponsor: BioNTech SE
Enrollment: 1470
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 13, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BioNTech SE

Eligibility Criteria

Inclusion Criteria

•1\. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial\-specific procedures.
•2\. Volunteers who at the time of consent are:
•\- Part A: 18 to 55 years old.
•\- Part B: 18 to 85 years old (\~60% should be 18 to 55 years old and \~40% 56 to 85 years old).
•\- Part C: 18 to 85 years old (\~60% should be 18 to 55 years old and \~40% 56 to 85 years old).
•3\. For Cohorts 1 to 5: in Part A, have received BNT162b2 vaccine (30 µg, two\-dose regimen) in either a clinical trial or as part of the governmental vaccination programs at least 6 months before Visit 0\. Subjects who are currently enrolled in the Phase III BNT162\-02 / C4591001 trial, have already been unblinded, and have previously received two doses of BNT162b2 with Dose 2 at least 6 months earlier can be included (for Cohorts 1 and 4 in Part B, prior enrollment and dosing in the BNT162\-02/C4591001 trial is mandatory). At enrollment into Part B of this trial, their participation in the BNT162\-02 / C4591001 trial will be terminated. Subjects should have not experienced COVID 19 based on medical history.
•4\. For Cohort 6: Are COVID 19 vaccine–naïve and have not experienced COVID 19 based on their medical history.
•5\. Are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other trial procedures.
•6\. Are overall healthy at Visit 0 in the clinical judgment of the investigator based on the medical history, clinical assessment (including physical examination, vital signs, blood and urine clinical laboratory tests, 12\-lead ECG, and oral swab for NAAT\-based SARS\-CoV\-2 testing).
•Note: Healthy volunteers with pre\-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before Visit 0, can be included.

Exclusion Criteria

•1\. Any existing condition which may affect vaccine injection and/or assessment of local reactions assessment, e.g., tattoos, severe scars, etc.
•2\. Any bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
•3\. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that, in the investigator’s judgment, make the subject inappropriate for the trial.
•4\. Any current febrile illness (body temperature \=38\.0°C/\=100\.4°F) or other acute illness within 48 h prior to Day 1/IMP injection in this trial.
•5\. Any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, unless such disease is not considered relevant for participation in this trial in the investigator's judgment.
•6\. History of COVID 19 and/or clinical (based on clinical confirmed COVID 19 symptoms/signs alone, if a SARS CoV 2 NAAT result was not available) or microbiological (based on COVID 19 symptoms/signs and a positive SARS CoV 2 NAAT result) evidence of prior infection with SARS CoV 2 at screening (Visit 0\).
•Note: not applicable for Part C.
•7\. History of Guillain\-Barré syndrome.
•8\. Known or suspected immunodeficiency.
•9\. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the trial IMPs.