This study will enroll individuals who have: * Completed primary series of mRNA COVID-19 vaccine, and * An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine. This group of patients is at high risk for severe COVID-19 disease due to pharmacologic immunosuppression and a high prevalence of non-transplant risk factors such as obesity and diabetes.
This study is a randomized, open-label multi-site trial designed to induce an enhanced antibody response to severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in kidney and liver transplant recipients who have ≤ 2500 U/mL anti-spike antibody (as measured by the Roche Elecsys® anti-SARS-CoV-2 S assay) after a completed primary series (3 doses) of mRNA COVID-19 vaccines. Participants will be randomized to either: 1. Receive a study dose of mRNA based COVID-19 vaccine (booster) with no change in their immunosuppressive regimen, or 2. Undergo a temporary, prescribed reduction in their maintenance immunosuppression (IS) regimen and receive a study dose (booster) of mRNA based COVID-19 vaccine. Protocol Version 8.0 will include a booster dose of either Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or Moderna COVID-19 Vaccine 2023-2024, with or without IS reduction. Duration of study participation for interested and eligible individuals: 13 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Administration: One dose administered intramuscularly.
Administration: One dose administered intramuscularly.
Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.
University of California, San Diego
San Diego, California, United States
University of California San Francisco Health
San Francisco, California, United States
The primary endpoint is the -fold increase in antibody titer (using the Roche Elecsys® anti-SARS-CoV-2 S assay) from before receiving the study dose of vaccine to 30 days after the study dose of vaccine.
Serum antibody titer will be measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay.
Time frame: Day 30 After Study Vaccination
Frequency of Solicited Local Reactogenicity Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 7 Post Study Vaccination
Frequency of Solicited Local Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 7 Post Study Vaccination
Frequency of Solicited Systemic Reactogenicity Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 7 Post Study Vaccination
Frequency of Solicited Systemic Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 7 Post Study Vaccination
Frequency of Any Serious Adverse Events (SAEs)
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 30 Post Study Vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.
Emory Healthcare
Atlanta, Georgia, United States
University of Illinois Health
Chicago, Illinois, United States
Northwestern University
Evanston, Illinois, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
Ochsner Health
New Orleans, Louisiana, United States
Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit
Baltimore, Maryland, United States
NYU Langone Transplant Institute
New York, New York, United States
Mt. Sinai Hospital
New York, New York, United States
...and 5 more locations
Frequency of Any Unsolicited Adverse Events (AEs)
Safety measure. An AE associated with the receipt of the study's COVID-19 mRNA vaccine and/or study mandated procedures.
Time frame: Through Day 30 Post Study Vaccination
Frequency of Any Serious Adverse Events (SAEs)
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 60 Post Study Vaccination
Frequency of Any Serious Adverse Events (SAEs)
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 365 Post Study Vaccination
Frequency of Any Unsolicited Adverse Events (AEs)
Safety measure. An AE associated with the receipt of of the study's COVID-19 mRNA vaccine and/or study mandated procedures.
Time frame: Through Day 365 Post Study Vaccination
Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection
Safety measure post receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 60 Post Study Vaccination
Proportion of Participants who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 60 Post Study Vaccination
Proportion of Participants with Graft Loss
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 60 Post Study Vaccination
Occurrence of Death Among Participants
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 60 Post Study Vaccination
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
A nasal mid-turbinate swab for SARS-CoV-2 PCR testing will be collected prior to administration of the COVID-19, at specified timepoints after receipt of vaccination and, in any case of suspected COVID-19 infection.
Time frame: Baseline (Day 0, Prior to Study Vaccination), Month 1, 3, 6, 9 and 12
Occurrence of Symptomatic COVID-19
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 365 Post Study Vaccination
Occurrence of COVID-19 Requiring Hospitalization
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Through Day 365 Post Study Vaccination
Change from Baseline in Anti-SARS-CoV-2 Antibody Levels at Day 30
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Baseline (Day 0, Prior to Study Vaccination),Day 30 After Study Vaccination
Change from Baseline in SARS-CoV-2 Antibody Levels
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: From Baseline (Day 0, Prior to Study Vaccination) to Day 365 Post Study Vaccination
Fold Increase in SARS-CoV-2 Antibody Levels: Limited to Participants With Detectable Antibody Levels at Baseline (Day 0)
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Time frame: Baseline (Day 0, Prior to Receipt of COVID-19 Study Vaccination), Day 30 After Study Vaccination