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Vaccine

Immunosuppression Adjustment for Kidney Transplant Recipients (CPAT-ISR Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening

Currently taking a tacrolimus-based immunosuppressive regimen as specified

Must not have

Recipients of any allograft other than a kidney or liver

Currently on an immunosuppressive regimen different from specified regimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people who have completed a 2-4 dose course of either the Moderna or Pfizer mRNA-based COVID-19 vaccine, and have an antibody response of ≤ 250 U/mL. This group is at high risk for severe COVID-19 disease.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical vaccine reactions like sore arm, fever, fatigue; risk of organ rejection due to reduced immunosuppression; and possible interaction with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I don't have antibodies against donor tissues.

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I am currently on a tacrolimus-based medication plan for my immune system.

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I have received at least 3 doses of Moderna or Pfizer COVID-19 vaccine.

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I understand the study and can give my consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received an organ transplant, but it was not a kidney or liver.

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I am on an immunosuppressive regimen not listed in the trial details.

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I am not on any immune-suppressing drugs except for those needed after a transplant.

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I have an autoimmune disease that could worsen if I reduce my immunosuppression treatment.

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I am HIV positive.

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I haven't taken COVID-19 treatment or prevention drugs in the last 6 months.

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I do not have any untreated active infections.

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I have not taken cell-depleting drugs in the last year.

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I have received specific COVID-19 vaccines.

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My graft is not functioning well.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0, prior to study vaccination), month 1, 3, 6, 9 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Change from Baseline in Anti-SARS-CoV-2 Antibody Levels at Day 30

Change from Baseline in SARS-CoV-2 Antibody Levels

Fold Increase in SARS-CoV-2 Antibody Levels: Limited to Participants With Detectable Antibody Levels at Baseline (Day 0)

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS RegimenExperimental Treatment2 Interventions

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

Group II: Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS ReductionExperimental Treatment2 Interventions

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

Group III: Moderna COVID-19 Vaccine 2023-2024 + SOC IS RegimenExperimental Treatment2 Interventions

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

Group IV: Moderna COVID-19 Vaccine 2023-2024 + SOC IS ReductionExperimental Treatment2 Interventions

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

0 / 14Eligibility criteria met