COVID-19 3rd Dose Vaccine in Transplant Patients

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05047640
• Other study ID #: 20210641
• Status: Terminated
• Phase: Phase 3
• Start date: September 14, 2021
• Est. completion date: October 25, 2022

Study information

• Verified date: June 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Biological:
• BNT162b2 vaccine
Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
• JNJ-78436735 Vaccine
Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Giselle Guerra

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)