COVID-19 3rd Dose Vaccine in Transplant Patients

Phase 3TerminatedNCT05047640

Giselle Guerra58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Covid19

Interventions

BNT162b2 vaccineBIOLOGICAL

Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle

JNJ-78436735 VaccineBIOLOGICAL

Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: Up to 1 month (post booster vaccination)

Secondary Outcomes

Proportion of Participants With a Positive COVID-19 Test

As assessed by medical records and or patient's report

Time frame: 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 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

Time frame: 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.

Time frame: Up to 7 days (post third dose)

Data from ClinicalTrials.gov

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