COVID-19 3rd Dose Vaccine in Transplant Patients

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

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 Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Biological: BNT162b2 vaccine; Biological: JNJ-78436735 Vaccine

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Giselle Guerra
• Investigators: Principal Investigator: Giselle Guerra, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): October 25, 2022
• Study Completion (Actual): October 25, 2022

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Estimated): June 4, 2024
• Last Update Submitted That Met QC Criteria: May 31, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: transplant patients
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 20210641

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No