Adjusting Immunosuppression to Improve COVID-19 Vaccine Response in Kidney Transplant Recipients
Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)
This study is testing if lowering the medication that suppresses the immune system can help kidney transplant recipients get a better response from their third COVID-19 vaccine shot.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT05060991 on ClinicalTrials.gov |
What this trial studies
This study investigates whether reducing immunosuppression can enhance the immune response to a third dose of mRNA COVID-19 vaccine in kidney transplant recipients. It is a prospective, randomized open-label trial involving participants who have previously received two doses of mRNA vaccines and are eligible for a third dose. The study aims to assess both the effectiveness of this approach in generating a better antibody response and the safety of reducing immunosuppression during the vaccination process.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients who have received two doses of mRNA COVID-19 vaccines and show low or negative antibody responses.
Not a fit: Patients who are pregnant or have contraindications to SARS-CoV-2 vaccination will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve COVID-19 vaccine responses in kidney transplant recipients, enhancing their protection against the virus.
How similar studies have performed: Previous studies have indicated that immunosuppressed individuals often have poor vaccine responses, but this specific approach of adjusting immunosuppression for improved vaccine efficacy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study * First or repeat kidney transplant recipient * Negative or low positive antibody titer on SARS-CoV-2 antibody assay * On a mycophenolate or azathioprine based immunosuppressive regimen * \> 6 months post-transplant Exclusion Criteria: * Pregnancy * Contraindication to SARS-CoV-2 vaccination (severe allergic reactions or anaphylaxis)
Where this trial is running
Sacramento, California
- University of California, Davis — Sacramento, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.