Back to resultsCOVID-19 3rd Dose Vaccine in Transplant Patients
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BNT162b2 vaccine
JNJ-78436735 Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Covid19 focused on measuring transplant patients
Eligibility 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BNT162b2 vaccine Group
JNJ-78436735 vaccine Group
Arm Description
Participants in this arm will receive one booster dose of the BNT162b2.
Participants in this arm will receive one booster dose of the JNJ-78436735
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Proportion of Participants With a Positive COVID-19 Test
As assessed by medical records and or patient's report
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
Number of Participants With Vaccine-related Adverse Events
Number of Participants with vaccine-related adverse events as collected by the study team.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05047640
Brief Title
COVID-19 3rd Dose Vaccine in Transplant Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
October 25, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Giselle Guerra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
transplant patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BNT162b2 vaccine Group
Arm Type
Experimental
Arm Description
Participants in this arm will receive one booster dose of the BNT162b2.
Arm Title
JNJ-78436735 vaccine Group
Arm Type
Experimental
Arm Description
Participants in this arm will receive one booster dose of the JNJ-78436735
Intervention Type
Biological
Intervention Name(s)
BNT162b2 vaccine
Intervention Description
Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
Intervention Type
Biological
Intervention Name(s)
JNJ-78436735 Vaccine
Intervention Description
Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
Primary Outcome Measure Information:
Title
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Description
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 Outcome Measure Information:
Title
Proportion of Participants With a Positive COVID-19 Test
Description
As assessed by medical records and or patient's report
Time Frame
Up to 1 month (post third dose)
Title
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
Description
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
Time Frame
Up to 1 month (post third dose)
Title
Number of Participants With Vaccine-related Adverse Events
Description
Number of Participants with vaccine-related adverse events as collected by the study team.
Time Frame
Up to 7 days (post third dose)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giselle Guerra, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
COVID-19 3rd Dose Vaccine in Transplant Patients
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