Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients

COVID-19 Clinical Trial

— ADIVKT  

Official title:

Impact of Immunosuppression Adjustment on the Immune Response to SARS-CoV-2 mRNA Vaccination in Kidney Transplant Recipients (ADIVKT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060991
• Other study ID #: 1801321-1
• Status: Recruiting
• Phase: Phase 4
• Start date: September 24, 2021
• Est. completion date: January 24, 2023

Study information

• Verified date: February 2022
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.

Description:

This is a prospective, randomized open-labeled study of kidney transplant recipients who have previously received two doses of mRNA COVID-19 vaccine (either BNT162b2, Pfizer-BioNTech or mRNA-1273, Moderna) and who are eligible to receive a 3rd dose of mRNA vaccine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 24, 2023
• Est. primary completion date: December 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19
• Immunosuppression
• Vaccine Response Impaired

Intervention

Drug:
• Reduction in antimetabolite immunosuppression
Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination

Locations

Country	Name	City	State
United States	University of California, Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	CareDx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline		6 weeks after receipt of 3rd dose mRNA vaccine
Primary	Percentage of participants who achieve high-positive antibody titer		6 weeks after receipt of 3rd dose mRNA vaccine
Secondary	Acute rejection		1 week to 16 weeks after intervention
Secondary	De Novo donor specific antibody (DSA) development		4 week to 16 weeks after intervention
Secondary	Change in donor-derived cell free DNA from baseline		1 week to 16 weeks after intervention
Secondary	Change in glomerular filtration rate (GFR) from baseline		1 week to 16 weeks after intervention
Secondary	Change in proteinuria from baseline		1 week to 16 weeks after intervention