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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

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ClinicalTrials.gov Identifier: NCT04949490
Recruitment Status : Completed
First Posted : July 2, 2021
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
BioNTech SE

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 SARS-CoV-2 Infection Biological: BNT162b2s01 Biological: BNT162b2 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 26, 2021
Actual Primary Completion Date : April 14, 2022
Actual Study Completion Date : September 16, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A, BNT162b2s01 30 µg (1 dose)
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.
 Biological: BNT162b2s01
intramuscular (IM) injection
Experimental: Group A, BNT162b2 30 µg (1 dose)
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.
 Biological: BNT162b2
IM injection
Other Name: Comirnaty
Experimental: Group B, BNT162b2 30 µg (2 doses)
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.
 Biological: BNT162b2
IM injection
Other Name: Comirnaty
Experimental: Group B transplant subjects, BNT162b2 30 µg (2 doses)
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.
 Biological: BNT162b2
IM injection
Other Name: Comirnaty


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: up to 26 weeks after the first IMP injection ]
    occurring up to 26 weeks after the first investigational medicinal product (IMP) injection. For all Group A and Group B participants.

  2. 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 [ Time Frame: up to 7 days after each IMP injection ]
    For Group A and for a selected subset of Group B participants.

  3. 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 [ Time Frame: up to 7 days after each IMP injection ]
    For Group A and for a selected subset of Group B participants.

  4. 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 [ Time Frame: up to 28 days after IMP injection ]
    For Group A and for a selected subset of Group B participants.


Secondary Outcome Measures :
  1. 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 [ Time Frame: day 1 and day 8; weeks 4, 12, and 26 ]
    For Group A participants.

  2. 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 [ Time Frame: Day 1 and day 8; weeks 3, 4, 7, 12, and 26 ]
    For Group B participants (except transplant subjects).

  3. SARS-CoV-2 functional cross-neutralization of variant B.1.351 to reference strain [ Time Frame: up to 26 weeks after the first IMP injection ]
    For Group A only.

  4. 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 [ Time Frame: From baseline (Day 1 of Dose 1) up to 26 weeks after Dose 2 ]
    For Group B transplant subjects.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04949490


Locations
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Germany
CRS Clinical Research Services Berlin GmbH
Berlin, Germany, 13353
University Hospital Frankfurt, Infectiology
Frankfurt, Germany, 60590
University Hospital Heidelberg, Clinical Pharmacology
Heidelberg, Germany, 69117
CRS Clinical Research Services Mannheim GmbH
Mannheim, Germany, 68167
Sponsors and Collaborators
BioNTech SE
Investigators
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Study Director: BioNTech Responsible Person BioNTech SE
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: BioNTech SE
ClinicalTrials.gov Identifier: NCT04949490    
Other Study ID Numbers: BNT162-14
2021-002387-50 ( EudraCT Number )
First Posted: July 2, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by BioNTech SE:
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
Additional relevant MeSH terms:
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Infections
COVID-19
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases