COVID-19 3rd Dose Vaccine in Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients

Conditions
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Covid19

Intervention / Treatment
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* Biological: BNT162b2 vaccine
* Biological: JNJ-78436735 Vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNT162b2 vaccine Group<br>Participants in this arm will receive one booster dose of the BNT162b2. | Biological: BNT162b2 vaccine<br>* Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle<br>|
| Experimental: JNJ-78436735 vaccine Group<br>Participants in this arm will receive one booster dose of the JNJ-78436735 | Biological: JNJ-78436735 Vaccine<br>* Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 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 | Up to 1 month (post booster vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With a Positive COVID-19 Test | As assessed by medical records and or patient's report | Up to 1 month (post third dose) | 
| Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | 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 | Up to 1 month (post third dose) | 
| Number of Participants With Vaccine-related Adverse Events | Number of Participants with vaccine-related adverse events as collected by the study team. | Up to 7 days (post third dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transplant patients