Back to resultsA Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
Primary Purpose
COVID-19, SARS-CoV-2 Infection
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
BNT162b2s01
BNT162b2
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction, RNA Virus Infections, Protection Against COVID-19 and Infections With SARS CoV 2, Prevention of COVID-19 disease
Eligibility Criteria
Inclusion Criteria:
- Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
- Willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the German and federal Governments, e.g., to follow good practices to reduce chances of spreading COVID 19), and other requirements of the trial.
- Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials.
- Remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. Screening clinical laboratory tests are to assess the participants "new baseline" unless required for eligibility. Note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia.
- Agree not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (day 50).
- Less than 18 months have passed since their last IMP injection in their parent trial.
- If they received 30 µg Comirnaty twice in the BNT162-01 trial, Visit 1 in this trial is ≥24 weeks after their last IMP injection, unless the subject is a Cohort 13 transplant subject of the BNT162-01 trial.
- If they received any other BNT162 vaccine candidate than Comirnaty in the BNT162-01 or BNT162-04 trial or are a Cohort 13 transplant subject, Visit 1 in this trial is ≥12 weeks after their last IMP injection.
- Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to day 1 (baseline). Participants who screen-fail on this criterion may be rescreened.
Exclusion Criteria:
- Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials.
- Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
- Have a current febrile illness (body temperature ≥38.0°C) or other acute illness within 48 hours prior to day 1/IMP injection in this trial. Participants who screen-fail on this criterion may be rescreened.
- Have received a live or live attenuated vaccine within 30 days prior to day 1/IMP injection, or any other vaccination within 14 days prior to day 1/IMP injection. Participants who screen-fail on this criterion may be rescreened.
- Have an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.
Sites / Locations
- CRS Clinical Research Services Berlin GmbH
- University Hospital Frankfurt, Infectiology
- University Hospital Heidelberg, Clinical Pharmacology
- CRS Clinical Research Services Mannheim GmbH
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group A, BNT162b2s01 30 µg (1 dose)
Group A, BNT162b2 30 µg (1 dose)
Group B, BNT162b2 30 µg (2 doses)
Group B transplant subjects, BNT162b2 30 µg (2 doses)
Arm Description
Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) will receive one booster injection of BNT162b2s01 on Day 1. Day 1 (baseline in this trial) must occur ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial.
Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) will receive one booster injection of BNT162b2 (Comirnaty) on Day 1. Day 1 (baseline in this trial) must occur ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial.
Trial participants in either the trial BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) will be offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. Day 1 (baseline in this trial) must occur ≥12 weeks after receiving the last BNT162 candidate vaccine in the respective parent BNT162-01 or BNT162-04 trial.
Transplant trial participants from Cohort 13 of the trial BNT162-01 will receive one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). Day 1 (baseline in this trial) must occur ≥12 weeks after receiving the last BNT162 candidate vaccine in the parent BNT162-01 trial.
Outcomes
Primary Outcome Measures
The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs)
occurring up to 26 weeks after the first investigational medicinal product (IMP) injection. For all Group A and Group B participants.
The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection
For Group A and for a selected subset of Group B participants.
The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection
For Group A and for a selected subset of Group B participants.
The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) occurring up to 28 days after IMP injection in each treatment group
For Group A and for a selected subset of Group B participants.
Secondary Outcome Measures
Neutralizing antibody titers and antibody titers (ELISA) to recombinant S1 and receptor binding domain (RBD) protein derived from reference and SARS-CoV-2 variant B.1.351 will be assessed at baseline (Day 1) and then Day 8, Weeks 4, 12, and 26
For Group A participants.
Neutralizing antibody titers and antibody titers (ELISA) to recombinant S1 and RBD protein derived from reference and SARS-CoV-2 variant B.1.351 will be assessed at baseline (Day 1) and then Day 8, Weeks 3, 4, 7, 12, and 26
For Group B participants (except transplant subjects).
SARS-CoV-2 functional cross-neutralization of variant B.1.351 to reference strain
For Group A only.
Neutralizing antibody titers and antibody titers (ELISA) to recombinant S1 and RBD protein derived from SARS-CoV-2 assessed at baseline and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2
For Group B transplant subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04949490
Brief Title
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
Official Title
A Phase II, Open-label, Rollover Trial to Evaluate the Safety and Immunogenicity of One or Two Boosting Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 Trial Subjects, or Two Boosting Doses of Comirnaty in BNT162-04 Trial Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 26, 2021 (Actual)
Primary Completion Date
April 14, 2022 (Actual)
Study Completion Date
September 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNTech SE
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern (VOC) strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in BNT162-04 trial participants.
Trial participants from BNT162-01 who received two injections of 30 μg Comirnaty will be randomized 2:1 to one booster injection (BNT162b2s01: Comirnaty). Trial participants in either the trial BNT162-01 or BNT162-04 who did not receive the full two vaccinations of 30 μg Comirnaty will be offered two injections of 30 μg Comirnaty as per the conditional marketing authorization. All potential rollover volunteers must enroll in this trial within less than 18 months of their last injection of a BNT162 candidate vaccine in the parent BNT162-01 or BNT162-04 trials.
Detailed Description
Group A trial participants will be randomized 2:1 to BNT162b2s01:Comirnaty. Group B trial participants will be allocated to trial treatment without active randomization and selected participants will be asked to participate in the detailed immunogenicity assessment based on their parent trial cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2 Infection
Keywords
Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction, RNA Virus Infections, Protection Against COVID-19 and Infections With SARS CoV 2, Prevention of COVID-19 disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A, BNT162b2s01 30 µg (1 dose)
Arm Type
Experimental
Arm Description
Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) will receive one booster injection of BNT162b2s01 on Day 1. Day 1 (baseline in this trial) must occur ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial.
Arm Title
Group A, BNT162b2 30 µg (1 dose)
Arm Type
Experimental
Arm Description
Trial participants from BNT162-01 (excluding transplant participants from Cohort 13) who received two injections of 30 μg BNT162b2 (Comirnaty) will receive one booster injection of BNT162b2 (Comirnaty) on Day 1. Day 1 (baseline in this trial) must occur ≥24 weeks after the last BNT162b2 (Comirnaty) injection in the parent BNT162-01 trial.
Arm Title
Group B, BNT162b2 30 µg (2 doses)
Arm Type
Experimental
Arm Description
Trial participants in either the trial BNT162-01 (excluding transplant participants from Cohort 13) or BNT162-04 who did not receive the full two vaccinations of 30 μg BNT162b2 (Comirnaty) will be offered two injections of 30 μg BNT162b2 (Comirnaty) as per the conditional marketing authorization on Day 1 and Day 21. Day 1 (baseline in this trial) must occur ≥12 weeks after receiving the last BNT162 candidate vaccine in the respective parent BNT162-01 or BNT162-04 trial.
Arm Title
Group B transplant subjects, BNT162b2 30 µg (2 doses)
Arm Type
Experimental
Arm Description
Transplant trial participants from Cohort 13 of the trial BNT162-01 will receive one injection of 30 μg BNT162b2 (Comirnaty) on Day 1 which will be followed 3 to 7 months afterward by a second injection of BNT162b2 (Comirnaty). Day 1 (baseline in this trial) must occur ≥12 weeks after receiving the last BNT162 candidate vaccine in the parent BNT162-01 trial.
Intervention Type
Biological
Intervention Name(s)
BNT162b2s01
Intervention Description
intramuscular (IM) injection
Intervention Type
Biological
Intervention Name(s)
BNT162b2
Other Intervention Name(s)
Comirnaty
Intervention Description
IM injection
Primary Outcome Measure Information:
Title
The proportion of participants in each treatment group with at least one serious adverse event (SAE) or the proportion of adverse events of special interest (AESIs)
Description
occurring up to 26 weeks after the first investigational medicinal product (IMP) injection. For all Group A and Group B participants.
Time Frame
up to 26 weeks after the first IMP injection
Title
The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 days after each IMP injection
Description
For Group A and for a selected subset of Group B participants.
Time Frame
up to 7 days after each IMP injection
Title
The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 days after each IMP injection
Description
For Group A and for a selected subset of Group B participants.
Time Frame
up to 7 days after each IMP injection
Title
The proportion of participants with at least one unsolicited treatment emergent adverse event (TEAE) occurring up to 28 days after IMP injection in each treatment group
Description
For Group A and for a selected subset of Group B participants.
Time Frame
up to 28 days after IMP injection
Secondary Outcome Measure Information:
Title
Neutralizing antibody titers and antibody titers (ELISA) to recombinant S1 and receptor binding domain (RBD) protein derived from reference and SARS-CoV-2 variant B.1.351 will be assessed at baseline (Day 1) and then Day 8, Weeks 4, 12, and 26
Description
For Group A participants.
Time Frame
day 1 and day 8; weeks 4, 12, and 26
Title
Neutralizing antibody titers and antibody titers (ELISA) to recombinant S1 and RBD protein derived from reference and SARS-CoV-2 variant B.1.351 will be assessed at baseline (Day 1) and then Day 8, Weeks 3, 4, 7, 12, and 26
Description
For Group B participants (except transplant subjects).
Time Frame
Day 1 and day 8; weeks 3, 4, 7, 12, and 26
Title
SARS-CoV-2 functional cross-neutralization of variant B.1.351 to reference strain
Description
For Group A only.
Time Frame
up to 26 weeks after the first IMP injection
Title
Neutralizing antibody titers and antibody titers (ELISA) to recombinant S1 and RBD protein derived from SARS-CoV-2 assessed at baseline and then Day 8, Weeks 4, 12, and 26 post Dose 1, and at Dose 2 (Day 1) and the Day 8, Weeks 4, 12, and 26 post Dose 2
Description
For Group B transplant subjects.
Time Frame
From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.
Willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the German and federal Governments, e.g., to follow good practices to reduce chances of spreading COVID 19), and other requirements of the trial.
Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials.
Remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. Screening clinical laboratory tests are to assess the participants "new baseline" unless required for eligibility. Note: in particular, caution should be used with a subject who has a history of cardiovascular disease, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy, or clinically significant arrhythmia.
Agree not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (day 50).
Less than 18 months have passed since their last IMP injection in their parent trial.
If they received 30 µg Comirnaty twice in the BNT162-01 trial, Visit 1 in this trial is ≥24 weeks after their last IMP injection, unless the subject is a Cohort 13 transplant subject of the BNT162-01 trial.
If they received any other BNT162 vaccine candidate than Comirnaty in the BNT162-01 or BNT162-04 trial or are a Cohort 13 transplant subject, Visit 1 in this trial is ≥12 weeks after their last IMP injection.
Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to day 1 (baseline). Participants who screen-fail on this criterion may be rescreened.
Exclusion Criteria:
Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials.
Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.
Have a current febrile illness (body temperature ≥38.0°C) or other acute illness within 48 hours prior to day 1/IMP injection in this trial. Participants who screen-fail on this criterion may be rescreened.
Have received a live or live attenuated vaccine within 30 days prior to day 1/IMP injection, or any other vaccination within 14 days prior to day 1/IMP injection. Participants who screen-fail on this criterion may be rescreened.
Have an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BioNTech Responsible Person
Organizational Affiliation
BioNTech SE
Official's Role
Study Director
Facility Information:
Facility Name
CRS Clinical Research Services Berlin GmbH
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University Hospital Frankfurt, Infectiology
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
University Hospital Heidelberg, Clinical Pharmacology
City
Heidelberg
ZIP/Postal Code
69117
Country
Germany
Facility Name
CRS Clinical Research Services Mannheim GmbH
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35653438
Citation
Quandt J, Muik A, Salisch N, Lui BG, Lutz S, Kruger K, Wallisch AK, Adams-Quack P, Bacher M, Finlayson A, Ozhelvaci O, Vogler I, Grikscheit K, Hoehl S, Goetsch U, Ciesek S, Tureci O, Sahin U. Omicron BA.1 breakthrough infection drives cross-variant neutralization and memory B cell formation against conserved epitopes. Sci Immunol. 2022 Sep 16;7(75):eabq2427. doi: 10.1126/sciimmunol.abq2427. Epub 2022 Sep 16.
Results Reference
derived
Learn more about this trial
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
We'll reach out to this number within 24 hrs