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

Sponsor
BioNTech SE (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04949490
Collaborator
(none)
549
Enrollment
4
Locations
3
Arms
23.2
Anticipated Duration (Months)
137.3
Patients Per Site
5.9
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: BNT162b2s01
  • Biological: BNT162b2
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
549 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 :
Jul 26, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Group A, BNT162b2s01 30 µg (1 dose)

Biological: BNT162b2s01
intramuscular (IM) injection

Experimental: Group A, BNT162b2 30 µg (1 dose)

Biological: BNT162b2
IM injection
Other Names:
  • Comirnaty
  • Experimental: Group B, BNT162b2 30 µg (2 doses)

    Biological: BNT162b2
    IM injection
    Other Names:
  • Comirnaty
  • Outcome Measures

    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) [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 [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 [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 [up to 28 days after IMP injection]

      For Group A and for a selected subset of Group B participants.

    Secondary Outcome Measures

    1. 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 [day 1 and day 8; weeks 4, 12, and 26]

      For Group A participants.

    2. 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 [day 1 and day 8; weeks 3, 4, 7, 12, and 26]

      For Group B participants.

    3. SARS-CoV-2 functional cross-neutralization of SA variant (B.1.351) to reference strain [up to 26 weeks after the first IMP injection]

      For Group A only.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    SiteCityStateCountryPostal Code
    1CRS Clinical Research Services Berlin GmbHBerlinGermany13353
    2University Hospital Frankfurt, InfectiologyFrankfurtGermany60590
    3University Hospital Heidelberg, Clinical PharmacologyHeidelbergGermany69117
    4CRS Clinical Research Services Mannheim GmbHMannheimGermany68167

    Sponsors and Collaborators

    • BioNTech SE

    Investigators

    • Study Director: BioNTech Responsible Person, BioNTech SE

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BioNTech SE
    ClinicalTrials.gov Identifier:
    NCT04949490
    Other Study ID Numbers:
    • BNT162-14
    • 2021-002387-50
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2021