Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
- Conditions
- COVID-19SARS-CoV-2 Infection
- Interventions
- Biological: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µgBiological: BNT162b4 30 µgBiological: BNT162b4 5 µgBiological: BNT162b4 10 µgBiological: BNT162b4 15 µgBiological: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg
- Registration Number
- NCT05541861
- Lead Sponsor
- BioNTech SE
- Brief Summary
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 (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 μg BNT162b4 when given alone as Dose 1 and Dose 2 in Cohort 5.
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. Cohort 5 participants will not be randomized and will receive two doses of BNT162b4 alone after which a safety review will be performed after all participants have received Dose 2 in this cohort.
BNT162b4 plus BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) will be co-administered (as a single injection).
BNT162b4 alone will be administered as a single injection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 383
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BNT162b2 Bivalent 30 µg + BNT162b4 5 µg - participants aged 18-55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 5 µg. Cohort 1. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). BNT612b2 Bivalent 30 µg - participants aged 18-55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection at Day 1. Cohorts 1, 2 and 3a. BNT612b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg. BNT162b2 Bivalent 30 µg + BNT162b4 10 µg - participants aged 18-55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 10 µg. Cohort 2. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1) BNT162b4 30 µg - participants aged 18-55 years BNT162b4 30 µg Intramuscular injection. Cohort 5. Two doses (at Day 1 and 2 months post-Dose 1 BNT612b2 Bivalent 30 µg - participants aged >55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection at Day 1. Cohort 3b. BNT612b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg. BNT162b2 Bivalent 30 µg + BNT162b4 5 µg - participants aged 18-55 years BNT162b4 5 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 5 µg. Cohort 1. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). BNT162b2 Bivalent 30 µg + BNT162b4 10 µg - participants aged 18-55 years BNT162b4 10 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 10 µg. Cohort 2. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1) BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged 18-55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3a. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged 18-55 years BNT162b4 15 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3a. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged 18-55 years BNT162b2 Monovalent (OMI XBB.1.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3a. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged >55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3b. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged >55 years BNT162b4 15 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3b. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 15 µg - participants aged >55 years BNT162b2 Monovalent (OMI XBB.1.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg. Cohort 3b. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 15 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 15 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged 18-55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4a. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged 18-55 years BNT162b4 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4a. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged 18-55 years BNT162b2 Monovalent (OMI XBB.1.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4a. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged >55 years BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4b. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged >55 years BNT162b4 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4b. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg BNT162b2 Bivalent/Monovalent 30 µg + BNT162b4 30 µg - participants aged >55 years BNT162b2 Monovalent (OMI XBB.1.5) 30 µg Intramuscular injection. BNT162b2 Bivalent (original/Omicron BA.4/BA.5)/Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg. Cohort 4b. Two doses (at Day 1 and 6 to 7 months post-Dose 1, if the participant consents to a second dose of IMP, otherwise only one dose at Visit V1). Dose 1: BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 µg + BNT162b4 30 µg, Dose 2: BNT162b2 Monovalent (OMI XBB.1.5) 30 µg + BNT162b4 30 µg
- Primary Outcome Measures
Name Time Method Frequency of dosed participants with solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after every investigational medicinal product (IMP) dose for each DL cohort Up to 7 days after every IMP dose Frequency of dosed participants with solicited systemic events (vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills and fever) recorded up to 7 days after every IMP dose for each DL cohort Up to 7 days after every IMP dose Frequency of dosed participants with at least one adverse event (AE) for each DL cohort Up to 28 days after every IMP dose AEs occurring up to 28 days after every IMP dose
Frequency of dosed participants with at least one serious adverse event (SAE) for each DL cohort Up to 6 months after every lMP dose or up to 3 months after last dose SAEs occurring up to 6 months (Cohorts 1-4) and up to 3 months (Cohort 5) after every IMP dose (Cohorts 1-4) and after last dose (Cohort 5)
Percentage of dosed participants with abnormal hematology or chemistry laboratory values for each DL cohort Up to 7 days after every IMP dose Abnormal values 3 days (Dose 1 sentinel group only, Cohorts 1-4) and 7 days after every IMP dose (all cohorts)
Percentage of dosed participants with grading shifts in hematology or chemistry laboratory for each DL cohort Up to 7 days after every IMP dose Assessments between baseline and 3 days (Dose 1 sentinel group only, Cohorts 1-4) and 7 days after every IMP dose (all cohorts)
Percentage of dosed participants with new electrocardiogram (ECG) abnormalities for each DL cohort Up to 7 days after every IMP dose ECG abnormalities 3 days (Dose 1 sentinel group only, Cohorts 1-4) and 7 days after every IMP dose (all cohorts). ECG abnormalities will be included that are consistent with probable or possible myocarditis or pericarditis as defined in the protocol.
- Secondary Outcome Measures
Name Time Method Geometric mean titers (GMT) at baseline and at 28 days after every IMP dose For the SARS-CoV-2 ancestral strain and SARS-CoV-2 Omicron BA.4/5, at baseline and at 28 days after every IMP dose. For SARS-CoV-2 Omicron XBB1.5, at pre-Dose 2 and at 28 days after Dose 2 Only for Cohorts 1-4. SARS-CoV-2 ancestral strain neutralizing titers and SARS-CoV-2 Omicron BA.4/5 and SARS-CoV-2 Omicron XBB1.5 neutralizing titers.
Geometric mean fold rises (GMFRs) from baseline to 28 days after every IMP dose For the SARS-CoV-2 ancestral strain and SARS-CoV-2 Omicron BA.4/5, from baseline to 28 days after every IMP dose. For SARS-CoV-2 Omicron XBB1.5, from pre-Dose 2 to 28 days after Dose 2 Only for Cohorts 1-4. SARS-CoV-2 ancestral strain neutralizing titers and SARS-CoV-2 Omicron BA.4/5 and SARS-CoV-2 Omicron XBB1.5 neutralizing titers.
Percentages of participants with seroresponse at 28 days after every IMP dose For the SARS-CoV-2 ancestral strain and SARS-CoV-2 Omicron BA.4/5, at 28 days after every IMP dose. For SARS-CoV-2 Omicron XBB1.5, at 28 days after Dose 2 Only for Cohorts 1-4. SARS-CoV-2 ancestral strain neutralizing titers and SARS-CoV-2 Omicron BA.4/5 and SARS-CoV-2 Omicron XBB1.5 neutralizing titers.
Trial Locations
- Locations (16)
Alliance for Multispecialty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Clinical Research Consulting, LLC
🇺🇸Milford, Connecticut, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
University of Kentucky Center for Clinical and Translational Science (outpatient clinic)
🇺🇸Lexington, Kentucky, United States
Cenexel RCA (Research Centers of America)
🇺🇸Hollywood, Florida, United States
Johnson County Clin-Trials, Inc. (JCCT)
🇺🇸Lenexa, Kansas, United States
California Research Foundation
🇺🇸San Diego, California, United States
Research Institute of South Florida, Inc.
🇺🇸Miami, Florida, United States
Clinical Trials of Texas, LLC / Flourish Research
🇺🇸San Antonio, Texas, United States
Endeavor Clinical Trials, LLC
🇺🇸San Antonio, Texas, United States
Great Lakes Clinical Trials LLC - Andersonville
🇺🇸Chicago, Illinois, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Hoag Hospital
🇺🇸Newport Beach, California, United States
Alliance for Multispecialty Research, LLC (Kansas)
🇺🇸Kansas City, Missouri, United States