COVID Protection After Transplant-Immunosuppression Reduction (NCT05077254) | Clinical Trial Compass
CompletedPhase 2
COVID Protection After Transplant-Immunosuppression Reduction
United States48 participantsStarted 2021-12-06
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Able to understand and provide informed consent
✓. Individual ≥18 years of age.
✓. Recipient of a kidney or liver transplant ≥12 months prior to enrollment, without allograft rejection in the 6 months preceding enrollment
✓. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening (Central Lab Test Determination).
✓. Currently taking one of the following tacrolimus-based immunosuppressive regimens:
✓. Received a minimum of 3 doses of either the Moderna coronavirus infectious disease 19 (COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine
✓. Participant must be ≥ 60 days after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent or bivalent COVID-19 vaccine at the time of study vaccine.
✓. Serum antibody negative or low (titer ≤ 2500 U/mL) at ≥ 30 days from the last dose of mRNA COVID-19 vaccine and ≥ 30 days following receipt of a monoclonal antibody product or convalescent plasma for COVID-19, measured using the Roche Elecsys® anti-SARS-CoV-2 S assay.
Exclusion criteria
✕. Currently on an immunosuppressive regimen different from the three regimens described in the Inclusion Criteria, for example (but not limited to) those including sirolimus, everolimus, belatacept, or azathioprine
✕. Recipient of any allograft other than a kidney or liver
What they're measuring
1
The -Fold Change 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.
Timeframe: Day 30 After Study Vaccination
Trial details
NCT IDNCT05077254
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)