AzTrials
AzTrials

Kidney Transplant RecipientsPhase 2CPAT-ISRNCT05077254

COVID Protection After Transplant-Immunosuppression Reduction

A Phase 2 study testing Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024 and SOC IS Regimen in people with Kidney Transplant Recipients and Liver Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024 and SOC IS Regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
15 sitesUnited States
Study dates
6 Dec 2021to 21 Feb 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals who meet all the following criteria are eligible for enrollment as study participants-
  • 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:
Show all 12Show fewer
  • Tacrolimus plus Mycophenolate Mofetil (MMF) or Mycophenolic Acid (MPA), with or without a corticosteroid
  • Tacrolimus with trough ≥ 5ng/mL with or without ≤5 mg of prednisone or equivalent
  • 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.
  • Participant's transplant physician or midlevel practitioner who is clinically licensed to prescribe and manage immunosuppression must confirm the participant's eligibility based on medical history.

Who cannot join

  • Individuals who meet any of these criteria are not eligible for enrollment as study participants-
  • 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
  • Participant is pregnant
  • Any past history of Donor Specific Antibody (DSA) using local site standards
  • Prior receipt of the Moderna COVID-19 Vaccine 2023-2024 or Pfizer-BioNTech COVID-19 Vaccine 2023-2024.
Show all 24Show fewer
  • Currently taking any systemic immunosuppressive agent, other than their prescribed transplant immunosuppression
  • Known history of severe allergic reaction to any component of an authorized or licensed COVID-19 vaccine
  • Thrombotic events, myocarditis, or pericarditis temporally associated with a prior dose of COVID-19 vaccine
  • History of heparin-induced thrombocytopenia
  • Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months
  • More than minimal graft dysfunction, in accordance with study definition
  • Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG), rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
  • Concurrent autoimmune disease at risk for exacerbation with immunosuppression reduction
  • Any untreated active infection including BK viremia >10^4 copies
  • Infection with human immunodeficiency virus (HIV)
  • Recent (within one year) or ongoing treatment for malignancy with the exception of:
  • Non- melanomatous skin cancer definitively treated by local therapy, and
  • Definitively treated carcinoma-in-situ of the cervix (Stage 0 cervical cancer)
  • Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or convalescent plasma within 6 months preceding enrollment, or
  • Any past or current medical problems, treatments, or findings which, in the opinion of the investigator, may:
  • pose additional risks from participation in the study,
  • interfere with the candidate's ability to comply with study requirements, or
  • impact the quality or interpretation of the data obtained from the study.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • Emory Healthcare

    Atlanta, Georgia, 30322

  • Johns Hopkins Institute for Clinical and Translational Research: Broadway Adult Outpatient Clinical Research Unit

    Baltimore, Maryland, 21287

  • University of Illinois Health

    Chicago, Illinois, 60612

  • Northwestern University

    Evanston, Illinois, 60208

  • Houston Methodist

    Houston, Texas, 77030

  • University of Iowa Hospitals

    Iowa City, Iowa, 52242

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53706

  • Ochsner Health

    New Orleans, Louisiana, 70121

  • NYU Langone Transplant Institute

    New York, New York, 10016

  • Mt. Sinai Hospital

    New York, New York, 10029

  • Weill Cornell Medicine

    New York, New York, 10065

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

  • University of California, San Diego

    San Diego, California, 92093

  • University of California San Francisco Health

    San Francisco, California, 94143

Other trials in United States

About this study

Official title: A Randomized Study to Evaluate Antibody Response to an Additional Dose of SARS-CoV-2 Vaccination With and Without Immunosuppression Reduction in Kidney and Liver Transplant Recipients

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.

Read the detailed description

This study is a randomized, open-label multi-site trial designed to induce an enhanced antibody response to severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) in kidney and liver transplant recipients who have ≤ 2500 U/mL anti-spike antibody (as measured by the Roche Elecsys® anti-SARS-CoV-2 S assay) after a completed primary series (3 doses) of mRNA COVID-19 vaccines.

Participants will be randomized to either:

  1. Receive a study dose of mRNA based COVID-19 vaccine (booster) with no change in their immunosuppressive regimen, or
  2. Undergo a temporary, prescribed reduction in their maintenance immunosuppression (IS) regimen and receive a study dose (booster) of mRNA based COVID-19 vaccine.

Protocol Version 8.0 will include a booster dose of either Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or Moderna COVID-19 Vaccine 2023-2024, with or without IS reduction.

Duration of study participation for interested and eligible individuals: 13 months.

Being tested
Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024, SOC IS Regimen, SOC IS Reduction
Keywords
mRNA COVID-19 vaccines, SARS-CoV-2 antibody response, immunosuppression (IS), coronavirus infectious disease 19, COVID-19, severe acute respiratory syndrome coronavirus type 2, SARS-CoV-2 protection
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pfizer-BioNTech COVID-19 Vaccine 2023-2024Biological

    Also called mRNA COVID-19 vaccine, BNT162b2 mRNA COVID-19 vaccine, SARS-CoV-2 RNA vaccine, Comirnaty

    Administration: One dose administered intramuscularly.

  • Moderna COVID-19 Vaccine 2023-2024Biological

    Also called mRNA COVID-19 vaccine, Moderna COVID-19 vaccine, SARS-CoV-2 vaccine, Spikevax

    Administration: One dose administered intramuscularly.

  • SOC IS RegimenDrug

    Also called Standard of Care transplant immunosuppression regimen, Immunosuppression (IS), mycophenolate mofetil (MMF) or equivalent, tacrolimus

    Participants will continue to take their prescribed immunosuppression (IS) medications without alterations in schedule and dosing, per protocol instruction.

  • SOC IS ReductionDrug

    Also called Standard of Care (SOC) transplant immunosuppression regimen, Immunosuppression (IS) Reduction, mycophenolate mofetil (MMF) or equivalent, tacrolimus

    Participants will reduce their standard of care immunosuppression medications (IS) before and after the COVID-19 vaccine booster (1 dose), per protocol instruction.

Study groups in NCT05077254
Study groupRoleWhat they receive
Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS RegimenExperimentalParticipants 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
Receives: Biological: Pfizer-BioNTech COVID-19 Vaccine 2023-2024; Drug: SOC IS Regimen
Pfizer-BioNTech COVID-19 Vaccine 2023-2024 + SOC IS ReductionExperimentalParticipants 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
Receives: Biological: Pfizer-BioNTech COVID-19 Vaccine 2023-2024; Drug: SOC IS Reduction
Moderna COVID-19 Vaccine 2023-2024 + SOC IS RegimenExperimentalParticipants 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
Receives: Biological: Moderna COVID-19 Vaccine 2023-2024; Drug: SOC IS Regimen
Moderna COVID-19 Vaccine 2023-2024 + SOC IS ReductionExperimentalParticipants 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
Receives: Biological: Moderna COVID-19 Vaccine 2023-2024; Drug: SOC IS Reduction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Serum antibody titer will be measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay. Values > 1 represent increase from baseline; values < 1 represent decrease from baseline.

    Measured: Day 30 After Study Vaccination

Secondary outcomes (15)

  1. Frequency of Solicited Systemic Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 7 Post Study Vaccination

  2. Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 7 post Vaccine dose

  3. Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 7 post Vaccine dose

  4. Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 7 post Vaccine dose

  5. Frequency of Any Serious Adverse Events (SAEs) During the 30 Days Following the Additional Dose of Vaccine

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 30 Post Study Vaccination

  6. Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection

    Safety measure post receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 60 Post Study Vaccination

  7. Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 90 Post Study Vaccination

  8. Proportion of Participants With Graft Loss

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 60 Post Study Vaccination

  9. Occurrence of Death Among Participants

    Safety measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 60 Post Study Vaccination

  10. Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)

    A nasal mid-turbinate swab for SARS-CoV-2 PCR testing will be collected prior to administration of the COVID-19, at specified timepoints after receipt of vaccination and, in any case of suspected COVID-19 infection.

    Measured: Baseline (Day 0, Prior to Study Vaccination), Month 1, 3, 6, 9 and 12

  11. Occurrence of Symptomatic COVID-19

    Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 365 Post Study Vaccination

  12. Occurrence of COVID-19 Requiring Hospitalization

    Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Through Day 365 Post Study Vaccination

  13. Change From Baseline in Anti-SARS-CoV-2 Antibody Levels at Day 30

    Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Baseline (Day 0, Prior to Study Vaccination),Day 30 After Study Vaccination

  14. Change From Baseline in SARS-CoV-2 Antibody Levels

    Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: From Baseline (Day 0, Prior to Study Vaccination) to Day 365 Post Study Vaccination

  15. Fold Change in SARS-CoV-2 Antibody Levels: Limited to Participants With Detectable Antibody Levels at Baseline (Day 0). (Values > 1 Represent an Increase From Baseline; Values < 1 Represent a Decrease From Baseline).

    Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.

    Measured: Baseline (Day 0, Prior to Receipt of COVID-19 Study Vaccination), Day 30 After Study Vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2021
  2. Study start6 Dec 2021
  3. Primary completion28 Feb 2024
  4. Study completion21 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to: * A study dose of mRNA COVID-19 vaccine only, or * Immunosuppression (IS) reduction plus a study dose of mRNA COVID-19 vaccine. IS reduction will be based on the participant's IS regimen upon study entry, in accordance with the study's protocol.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05077254
Sponsor's protocol ID
DAIT COVID19-TB-03
Other IDs
U01AI138897, NIAID CRMS ID#: 38892
Acronym
CPAT-ISR
Status last verified
Apr 2026
First submitted
12 Oct 2021
Last updated
23 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Publications

  • Werbel WA, Boyarsky BJ, Ou MT, Massie AB, Tobian AAR, Garonzik-Wang JM, Segev DL. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series. Ann Intern Med. 2021 Sep;174(9):1330-1332. doi: 10.7326/L21-0282. Epub 2021 Jun 15. No abstract available.

    PubMed 34125572

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024 and SOC IS Regimen in people with Kidney Transplant Recipients and Liver Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 15 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Day 30 After Study Vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05077254, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in