Immunosuppression Adjustment for Kidney Transplant Recipients
(CPAT-ISR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best way to protect kidney transplant patients from severe COVID-19. It compares the effects of two COVID-19 vaccines—Moderna and Pfizer-BioNTech—combined with varying levels of immunosuppressive medication, which lowers immune response to prevent organ rejection. The trial seeks participants who have had a kidney transplant for over a year, are on specific immunosuppressive treatments, and have a low antibody response to the COVID-19 vaccine. Kidney transplant recipients concerned about COVID-19 may find this trial suitable. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on specific immunosuppressive regimens, so you may need to adjust your current medications if they don't match the required regimens. It's best to discuss this with your transplant physician to confirm your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both the Moderna and Pfizer-BioNTech COVID-19 vaccines are generally well-tolerated. Studies on the Moderna vaccine indicate it creates a strong immune response in organ transplant recipients, such as those with kidney transplants, which is a positive sign for its safety in this group. The Pfizer-BioNTech vaccine is approved for preventing COVID-19 across different age groups, with safety data gathered from many participants. Some report side effects like sore arms, tiredness, and mild flu-like symptoms, but these usually resolve quickly.
As this study is in an early phase, researchers continue to monitor the safety of these vaccines in transplant recipients. However, their approval for widespread use suggests a good safety record.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores how to best adjust immunosuppressive therapy for kidney transplant patients receiving COVID-19 vaccinations. The trial is investigating whether reducing standard immunosuppressive medications when administering either the Moderna or Pfizer-BioNTech bivalent COVID-19 vaccines can enhance immune response without compromising the transplant's success. This is particularly intriguing because balancing the immune system's protection against COVID-19 while ensuring the transplanted kidney is not rejected is a critical challenge. By potentially optimizing the timing and dosage of immunosuppressive drugs with these vaccines, this study aims to improve health outcomes and quality of life for kidney transplant recipients.
What evidence suggests that this trial's treatments could be effective for kidney transplant recipients at high risk for severe COVID-19?
This trial will evaluate the effects of different COVID-19 vaccination strategies for kidney transplant recipients. Participants will receive either the Pfizer-BioNTech or Moderna bivalent COVID-19 vaccines. Some will continue their standard immunosuppression regimen, while others will undergo a reduction. Research has shown that these vaccines help protect kidney transplant patients from severe COVID-19. One study found that only about a third of kidney transplant recipients developed a strong antibody response after full vaccination with Pfizer-BioNTech, suggesting that booster doses might help. Another study found that the Moderna vaccine successfully triggered immune responses in these patients, who are at higher risk due to weakened immune systems. Updated versions of the Moderna vaccine are believed to offer significant health benefits in preventing COVID-19 in high-risk groups. Overall, these vaccines effectively reduce severe illness and hospitalization in transplant patients.12567
Who Is on the Research Team?
Dorry L. Segev, MD, PhD
Principal Investigator
Transplant Surgery, Johns Hopkins University School of Medicine
Peter S. Heeger, MD
Principal Investigator
Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai
Christian P. Larsen, MD, DPhil
Principal Investigator
Emory Transplant Center, Emory University School of Medicine
Are You a Good Fit for This Trial?
Adults over 18 who've had a kidney or liver transplant at least a year ago without recent rejection, on specific tacrolimus-based immunosuppression, with low antibody response after COVID-19 vaccination. Excludes those with other organ transplants, severe vaccine allergies, certain medical conditions or treatments that could affect the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a booster dose of mRNA COVID-19 vaccine with or without immunosuppression reduction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Moderna Bivalent COVID-19 Vaccine
- Moderna COVID-19 Vaccine Booster
- Pfizer-BioNTech Bivalent COVID-19 Vaccine
- Pfizer-BioNTech COVID-19 Vaccine Booster
- SOC IS Reduction
- SOC IS Regimen
Trial Overview
The study tests if reducing immunosuppression and administering updated Pfizer-BioNTech or Moderna COVID-19 vaccines can better protect transplant recipients against COVID-19 while maintaining organ function.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. SOC IS: Standard of Care transplant immunosuppression regimen
Participants will receive an additional dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024, with concurrent reduction of their standard of care transplant immunosuppression regimen (IS), per protocol. SOC IS Reduction: Standard of Care transplant immunosuppression regimen reduction, per protocol
Participants will receive an additional dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. SOC IS: Standard of Care transplant immunosuppression regimen
Participants will receive a study dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024, with concurrent reduction of their standard of care transplant immunosuppression regimen (IS), per protocol. SOC IS Reduction: Standard of Care transplant immunosuppression regimen reduction, per protocol
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
PPD DEVELOPMENT, LP
Industry Sponsor
David Simmons
PPD DEVELOPMENT, LP
Chief Executive Officer since 2012
BSc in Applied Science from Georgia Institute of Technology
Martina Flammer
PPD DEVELOPMENT, LP
Chief Medical Officer since 2024
MD
PPD Development, LP
Industry Sponsor
PPD
Industry Sponsor
Dr. Austin Smith
PPD
Chief Medical Officer since 2020
Doctor of Medicine from the Royal College of Surgeons in Ireland
David Simmons
PPD
Chief Executive Officer since 2012
Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University
Johns Hopkins University
Collaborator
Citations
Moderna COVID-19 Vaccine (2024-2025 Formula) Letter of ...
effectiveness data reported in two manuscripts on solid organ transplant recipients. The first study was a double-blind, randomized ...
Moderna COVID-19 Resources - Presentations and ...
mRNA-1273 COVID-19 vaccine induces CD4+ T-cell responses among solid organ transplant recipients ... This study evaluated the effectiveness of mRNA-1273 bivalent ...
Clinical Impact and Cost-Effectiveness of Updated 2023/24 ...
Updated 2023/24 Moderna COVID-19 vaccination was estimated to provide significant health benefits through prevention of COVID-19 in high-risk populations.
COVID Protection After Transplant-Immunosuppression ...
Participants will receive an additional dose (1 dose) of the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant ...
Impact of Immunosuppressive Therapy, Vaccination, and ...
Outcomes after COVID‐19 in organ transplant recipients by vaccine doses received. Patients by number of vaccine doses received before COVID‐19.
Spikevax (previously COVID-19 Vaccine Moderna)
Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.
FACT SHEET FOR HEALTHCARE PROVIDERS ...
Safety data for Moderna COVID-19 Vaccine from the blinded portion of. Study 3 included data in 4,002 participants 6 years through 11 years of age who ...
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