COVID-19 3rd Dose Vaccine in Transplant Patients
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: BNT162b2 vaccine 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 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
|
Outcome Measures
Primary Outcome Measures
- Anti-spike protein of SARS-CoV-2 virus IgG positive rate [Up to 1 month (post booster vaccination)]
Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples
Secondary Outcome Measures
- Incidence of COVID-19 infection [Up to 1 month (post infection)]
As assessed by medical records and or patient's report
- Number of participants with COVID-19 symptom severity as measured by the WHO scale [Up to 1 month (post infection)]
World Health Organization (WHO) scale is scored between from 0 -10. 0: Uninfected; non-viral Ribonucleic Acid (RNA) detected Asymptomatic; viral RNA detected Symptomatic; Independent Symptomatic; Assistance needed Hospitalized; No oxygen therapy Hospitalized; oxygen by mask or nasal prongs Hospitalized; oxygen by Non-invasive Ventilation (NIV) or High flow Intubation and Mechanical ventilation, partial pressure of oxygen (pO2) /fraction of inspired oxygen (FIO2) >=150 or oxygen saturation (SpO2) /FIO2>=200 Mechanical ventilation, (pO2/FIO2<150 OR SpO2/FIO2<200) or vasopressors (norepinephrine >0.3 microg/kg/min) Mechanical ventilation, pO2/FIO2<150 and vasopressors (norepinephrine >0.3 microg/kg/min), or Dialysis or extracorporeal membrane oxygenation (ECMO) Dead
- Incidence of vaccine-related adverse events [Up to 7 days (post vaccination)]
As assessed by treating physician
Eligibility Criteria
Criteria
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 SARS-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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- Giselle Guerra
Investigators
- Principal Investigator: Giselle Guerra, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20210641