Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
58 participants
INTERVENTIONAL
2021-09-14
2022-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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BNT162b2 vaccine Group
Participants in this arm will receive one booster dose of the BNT162b2.
BNT162b2 vaccine
Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
JNJ-78436735 vaccine Group
Participants in this arm will receive one booster dose of the JNJ-78436735
JNJ-78436735 Vaccine
Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
Interventions
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BNT162b2 vaccine
Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
JNJ-78436735 Vaccine
Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
Eligibility Criteria
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Inclusion Criteria
* Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors.
* Patients with active graft with at least one immunosuppressive medication
* Completed two doses of BNT162b2 vaccination at least 28 days ago
Exclusion Criteria
* Any significant side effect with previous COVID-19 vaccination
* Within 28 days of BNT162b2 vaccine completion
* Already received more than and equal to three doses of COVID-19 vaccination
* Previously received COVID-19 vaccine other than BNT162b2 vaccine
* Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination.
* Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)
* History of Capillary Leak Syndrome
* Adults unable to consent
* Individuals who are not yet adults (younger than 18 year old)
* Vulnerable patients (prisoners)
* Pregnant women
18 Years
ALL
No
Sponsors
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Giselle Guerra
OTHER
Responsible Party
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Giselle Guerra
Medical Director of Transplant Services
Principal Investigators
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Giselle Guerra, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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References
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Natori Y, Martin E, Mattiazzi A, Arosemena L, Burke GW, Munagala MR, Manickavel S, Sota K, Pallikkuth S, Chen J, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. Post hoc analysis: 6 Months immunogenicity after third dose of BNT162b2 vs JNJ-78,436,735 after two doses of BNT162b2 vaccine in solid organ transplant recipients. Immunol Lett. 2025 Jun;273:106968. doi: 10.1016/j.imlet.2024.106968. Epub 2025 Jan 9.
Natori Y, Martin E, Mattiazzi A, Arosemena L, Ortigosa-Goggins M, Shobana S, Roth D, Kupin WL, Burke GW, Ciancio G, Morsi M, Phancao A, Munagala MR, Butrous H, Manickavel S, Sinha N, Sota K, Pallikkuth S, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients. Transpl Int. 2023 Apr 5;36:10938. doi: 10.3389/ti.2023.10938. eCollection 2023.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20210641
Identifier Type: -
Identifier Source: org_study_id
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