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Purpose

The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients 18 years of age and older - 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

  • Patient with non-active graft - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BNT162b2 vaccine Group 		Participants in this arm will receive one booster dose of the BNT162b2.
  • Biological: BNT162b2 vaccine
    Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
Experimental
JNJ-78436735 vaccine Group 		Participants in this arm will receive one booster dose of the JNJ-78436735
  • Biological: JNJ-78436735 Vaccine
    Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle

Recruiting Locations

More Details

NCT ID
NCT05047640
Status
Terminated
Sponsor
Giselle Guerra

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.