This is an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent to select a safe and tolerable dose. Cohorts 1, 2, 3a, 3b, 4a, and 4b are observer-blind for Dose 1, through Visit 5 only. Given that only prior recipients of BNT162b4 will receive Dose 2, Dose 2 will be open-label. In each cohort, the DLs for Dose 1 and Dose 2 will be the same.
The trial will use a staggered dosing process schema, i.e., enrollment into the next higher dose level is done sequentially and subject to safety data from the previous dose levels, with sentinel participants in Cohorts 1, 2, 3a, and 4a. Cohort 3b investigating the same dose level as cohort 3a but in participants aged >55 years will be opened after safety data for participants aged 18-55 years in Cohort 3a has been reviewed. Enrollment into Cohorts 4a and 4b will be opened after safety data for Cohort 3a and 3b has been reviewed.
BNT162b4 plus BNT162b2 Bivalent will be administered concomitantly (as a single injection).
Closest Location
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.
Condition
SARS-CoV-2 Infection, COVID-19
Sex
Male or Female
Age
18+ years