COVID-19 3rd Dose Vaccine in Transplant Patients

Phase 3

Terminated

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)	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

Name	Time	Method
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale	Up to 1 month (post third dose)	World Health Organization (WHO) scale is scored between from 0 -10. 0: Uninfected; non-viral Ribonucleic Acid (RNA) detected 1. Asymptomatic; viral RNA detected 2. Symptomatic; Independent 3. Symptomatic; Assistance needed 4. Hospitalized; No oxygen therapy 5. Hospitalized; oxygen by mask or nasal prongs 6. Hospitalized; oxygen by Non-invasive Ventilation (NIV) or High flow 7. Intubation and Mechanical ventilation, partial pressure of oxygen (pO2) /fraction of inspired oxygen (FIO2) \>=150 or oxygen saturation (SpO2) /FIO2\>=200 8. Mechanical ventilation, (pO2/FIO2\<150 OR SpO2/FIO2\<200) or vasopressors (norepinephrine \>0.3 microg/kg/min) 9. Mechanical ventilation, pO2/FIO2\<150 and vasopressors (norepinephrine \>0.3 microg/kg/min), or Dialysis or extracorporeal membrane oxygenation (ECMO) 10. Dead
Number of Participants With Vaccine-related Adverse Events	Up to 7 days (post third dose)	Number of Participants with vaccine-related adverse events as collected by the study team.
Proportion of Participants With a Positive COVID-19 Test	Up to 1 month (post third dose)	As assessed by medical records and or patient's report