Clincosm LogoSign in Get a demo

COVID-19 3rd Dose Vaccine in Transplant Patients

Sponsor
Giselle Guerra (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05047640
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
13.5
Anticipated Duration (Months)
14.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BNT162b2 vaccine
  • Biological: JNJ-78436735 Vaccine
 Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 14, 2021
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: BNT162b2 vaccine

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

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

Outcome Measures

Primary Outcome Measures

  1. Anti-spike protein of SARS-CoV-2 virus IgG positive rate [Up to 1 month (post booster vaccination)]

    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

  1. Incidence of COVID-19 infection [Up to 1 month (post infection)]

    As assessed by medical records and or patient's report

  2. Number of participants with COVID-19 symptom severity as measured by the WHO scale [Up to 1 month (post infection)]

    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

  3. Incidence of vaccine-related adverse events [Up to 7 days (post vaccination)]

    As assessed by treating physician

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Miami Miami Florida United States 33136

Sponsors and Collaborators

  • Giselle Guerra

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Giselle Guerra, Medical Director of Transplant Services, University of Miami
ClinicalTrials.gov Identifier:
NCT05047640
Other Study ID Numbers:
  • 20210641
First Posted:
Sep 17, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Giselle Guerra, Medical Director of Transplant Services, University of Miami
transplant patients
Additional relevant MeSH terms:
COVID-19
Vaccines

Study Results

No Results Posted as of Aug 3, 2022