Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
Completed · Phase 1
Conditions studied: SARS-CoV-2 Infection, COVID-19
In brief
This was 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 (original/Omicron BA.4/BA.5) to select a safe and tolerable dose and to evaluate BNT162b4 + BNT162b2 Bivalent (original/Omicron BA.4/BA.5) when given as Dose 1 and Dose 2 (booster) in Cohorts 1 and 2 and BNT162b4 + BNT162b2 Monovalent (OMI XBB.1.5) when given as Dose 2 (booster) in Cohorts 3a, 3b, 4a, and 4b, and 30 microgram (mcg) BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5. The trial used a staggered dosing process schema, i.e., enrollment into the next higher dose level was 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 was opened after safety data for participants aged 18-55 years in Cohort 3a had been reviewed. Enrollment into Cohorts 4a and 4b was opened after safety data for Cohort 3a and 3b had been reviewed. Cohort 5 participants were not randomized and received two doses of BNT162b4 alone after which a safety review was performed after all participants received Dose 2 in this cohort. BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) was co-administered (as a single injection). BNT162b4 alone was administered as a single injection.
Key facts
- Study ID
- NCT05541861
- Run by
- BioNTech SE
- People needed
- 383
- Starts
- 2022-11-08
- Expected to finish
- 2024-11-22
- Last updated by the study team
- 2026-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Alliance for Multispecialty Research, LLC — Tempe, Arizona, United States
- Hoag Hospital — Newport Beach, California, United States
- California Research Foundation — San Diego, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- Clinical Research Consulting, LLC — Milford, Connecticut, United States
- Cenexel RCA (Research Centers of America) — Hollywood, Florida, United States
- Research Institute of South Florida, Inc. — Miami, Florida, United States
- Great Lakes Clinical Trials LLC - Andersonville — Chicago, Illinois, United States
- Johnson County Clin-Trials, Inc. (JCCT) — Lenexa, Kansas, United States
- University of Kentucky Center for Clinical and Translational Science (outpatient clinic) — Lexington, Kentucky, United States
- Alliance for Multispecialty Research, LLC (Kansas) — Kansas City, Missouri, United States
- Finger Lakes Clinical Research — Rochester, New York, United States
- CTI Clinical Research Center — Cincinnati, Ohio, United States
- Alliance for Multispecialty Research, LLC — Knoxville, Tennessee, United States
- Clinical Trials of Texas, LLC / Flourish Research — San Antonio, Texas, United States
- Endeavor Clinical Trials, LLC — San Antonio, Texas, United States
- DM Clinical Research — Tomball, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.