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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04949490
Recruitment Status : Active, not recruiting
First Posted : July 2, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
BioNTech SE

Tracking Information
First Submitted Date  ICMJE June 25, 2021
First Posted Date  ICMJE July 2, 2021
Last Update Posted Date January 13, 2022
Actual Study Start Date  ICMJE July 26, 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2021)
  • 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 ]
    SAE/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 [ Time Frame: 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 [ Time Frame: 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) or at least one adverse event (AE) related to IMP occurring up to 28 days after IMP injection in each treatment group [ Time Frame: up to 28 days after IMP injection ]
    For Group A participants only.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2021)
  • Antibody titers to recombinant S1 and receptor binding domain (RBD) protein derived from reference and SARS-CoV-2 Republic of South Africa (SA) 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.
  • Antibody titers to recombinant S1 and RBD protein derived from reference and SARS-CoV-2 SA 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.
  • SARS-CoV-2 functional cross-neutralization of SA variant (B.1.351) to reference strain [ Time Frame: up to 26 weeks after the first IMP injection ]
    For Group A only.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19
  • SARS-CoV-2 Infection
Intervention  ICMJE
  • Biological: BNT162b2s01
    intramuscular (IM) injection
  • Biological: BNT162b2
    IM injection
    Other Name: Comirnaty
Study Arms  ICMJE
  • Experimental: Group A, BNT162b2s01 30 µg (1 dose)
    Intervention: Biological: BNT162b2s01
  • Experimental: Group A, BNT162b2 30 µg (1 dose)
    Intervention: Biological: BNT162b2
  • Experimental: Group B, BNT162b2 30 µg (2 doses)
    Intervention: Biological: BNT162b2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 12, 2022)
137
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2021)
549
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04949490
Other Study ID Numbers  ICMJE BNT162-14
2021-002387-50 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioNTech SE
Study Sponsor  ICMJE BioNTech SE
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: BioNTech Responsible Person BioNTech SE
PRS Account BioNTech SE
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP