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Kidney Transplant RecipientsPhase 2CPATNCT04969263

COVID-19 Protection After Transplant Pilot Study

A Phase 2 study testing BNT162b2 vaccine (Pfizer/BioNTech) and mRNA-1273 vaccine (Moderna) in people with Kidney Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

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

Official record
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Trial summary

Antibodies are an important part of the body's defense against infection. Individuals who have no antibodies or very low antibody levels are considered less well protected from Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplant Recipients
What is being tested?
BNT162b2 vaccine (Pfizer/BioNTech) and mRNA-1273 vaccine (Moderna)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited States
Study dates
10 Aug 2021to 10 Mar 2023
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;
  • Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment;
  • Received 2 doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine as specified in the respective Food and Drug Administration Emergency Use Authorization (FDA EUAs), >30 days and <8 months prior to enrollment ; and,
  • Negative (antibody titer < 0.8U/mL) or low (antibodies detected at titer ≤ 50 U/mL) response to the vaccine at > 30 days from dose 2 of the Moderna COVID-19 vaccine or the Pfizer BioNTech vaccine, using the Roche Elecsys® anti-Receptor Binding Domain (RBD) assay.

Who cannot join

  • Individuals who meet any of these criteria are not eligible for enrollment as study participants-
  • Recipient of any number of doses of any COVID vaccine product other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine;
  • Known history of severe allergic reaction to any component of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine;
  • Thrombotic events, myocarditis, or pericarditis temporally associated with prior dose of COVID-19 vaccine;
  • Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months;
  • Significant graft dysfunction;
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  • Receipt of any cellular depleting agent (e.g. ATG, Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment;
  • Receiving systemic immunomodulatory medication(s) for any condition other than transplant;
  • Any untreated active infection, including BK viremia >10^4 copies;
  • Infection with human immunodeficiency virus (HIV);
  • Maintenance immunosuppressive regimen that includes belatacept or abatacept;
  • Recent (within one year) or ongoing treatment for malignancy; 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, may interfere with the candidate's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Immunogenicity of a Third Dose of Either the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine in Kidney Transplant Recipients Who Failed to Respond After Two Previous Doses

Antibodies are an important part of the body's defense against infection. Individuals who have no antibodies or very low antibody levels are considered less well protected from Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. What level of antibodies is necessary for protection is currently unknown.

Inadequate antibody response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination has been described among kidney transplant recipients. The aim of this study is to elicit an antibody response to vaccination against SARS-CoV-2 in kidney transplant recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) vaccine.

Read the detailed description

This is an open label, non-randomized study in kidney transplant recipients who received two doses of either mRNA COVID-19 vaccine and have a negative (<0.8 U/mL) or low (titer <50 U/mL) SARS-CoV-2 antibody response using the Roche Elecsys® anti-RBD assay. Eligible participants will receive a third dose of the same mRNA vaccine as the prior two doses.

Being tested
BNT162b2 vaccine (Pfizer/BioNTech), mRNA-1273 vaccine (Moderna)
Keywords
COVID-19 vaccine, SARS-CoV-2 antibody response

What participants receive

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

  • BNT162b2 vaccine (Pfizer/BioNTech)Biological

    Also called COMIRNATY (COVID-19 vaccine, mRNA), SARS-CoV-2 mRNA vaccine, Pfizer-BioNTech COVID-19 vaccine

    30 microgram dose

  • mRNA-1273 vaccine (Moderna)Biological

    Also called SARS-CoV-2 mRNA vaccine, Moderna COVID-19 vaccine, SPIKEVAX (COVID-19 vaccine, mRNA)

    100 microgram dose

Study groups in NCT04969263
Study groupRoleWhat they receive
BNT162b2 mRNA-based vaccine (Pfizer/BioNTech)ExperimentalThe BNT162b2 mRNA-based vaccine was developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Kidney transplant recipients who had a suboptimal antibody response to the standard two doses of vaccination with Pfizer/BioNTech will receive a third dose of the the same vaccine. Administration: One dose administered intramuscularly, upper arm.
Receives: Biological: BNT162b2 vaccine (Pfizer/BioNTech)
mRNA-1273 vaccine (Moderna)ExperimentalThe mRNA-1273 vaccine was developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. Kidney transplant recipients who had a suboptimal antibody response to the standard two doses of vaccination with Moderna will receive a third dose of the same vaccine. Administration: One dose administered intramuscularly, upper arm.
Receives: Biological: mRNA-1273 vaccine (Moderna)

What is being measured

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

  1. Proportion of Recipients Who Achieve an Antibody Response >50 U/mL After the Third Dose of mRNA COVID-19 Vaccine

    The proportion of participants who achieve an antibody response >50 U/mL after the third dose of vaccine using the Roche Elecsys® anti-RBD assay is considered to show positive response to the intervention, negative response otherwise.

    Measured: Outcome was measured at 30 days after study intervention (dose 3 vaccination)

Secondary outcomes (6)

  1. Frequency of/Proportion of Participants With Vaccine Reactogenicity (Local or Systemic) and/or Allergy to the mRNA-Based COVID-19 Vaccine

    Safety measure status post third dose of mRNA vaccine

    Measured: Through Day 7 Post-Vaccination (Dose 3)

  2. Frequency of/Proportion of Participants With Any Serious Adverse Events (SAEs) Following the Third Dose of an mRNA Vaccine

    Safety measure status post third dose of mRNA vaccine

    Measured: Through Day 30 Post-Vaccination (Dose 3)

  3. Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection (Clinical or Biopsy Proven)

    Safety measure status post third dose of mRNA vaccine

    Measured: Through Day 60 Post-Vaccination (Dose 3)

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

    Safety measure status post third dose of mRNA vaccine

    Measured: Through Day 90 Post-Vaccination (Dose 3)

  5. Proportion of Participants With Graft Loss

    Safety measure status post third dose of mRNA vaccine.

    Measured: Through Day 60 Post-Vaccination (Dose 3)

  6. Occurrence of Death Among Participants

    Safety measure status post third dose of mRNA vaccine.

    Measured: Through Day 60 Post-Vaccination (Dose 3)

Timeline

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

  1. First posted20 Jul 2021
  2. Study start10 Aug 2021
  3. Primary completion10 Nov 2022
  4. Study completion10 Mar 2023

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Open label, non-randomized.
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04969263
Sponsor's protocol ID
DAIT COVID19-TB-02
Other IDs
NIAID CRMS ID#: 38865
Acronym
CPAT
Status last verified
Jul 2025
First submitted
16 Jul 2021
Last updated
30 Jul 2025
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

  • Karaba AH, Morgenlander WR, Johnston TS, Hage C, Pekosz A, Durand CM, Segev DL, Robien MA, Heeger PS, Larsen CP, Blankson JN, Werbel WA, Larman HB, Tobian AAR. Epitope Mapping of SARS-CoV-2 Spike Antibodies in Vaccinated Kidney Transplant Recipients Reveals Poor Spike Coverage Compared to Healthy Controls. J Infect Dis. 2024 May 15;229(5):1366-1371. doi: 10.1093/infdis/jiad534.

    PubMed 38019656

  • Werbel WA, Karaba AH, Chiang TP, Massie AB, Brown DM, Watson N, Chahoud M, Thompson EA, Johnson AC, Avery RK, Cochran WV, Warren D, Liang T, Fribourg M, Huerta C, Samaha H, Klein SL, Bettinotti MP, Clarke WA, Sitaras I, Rouphael N, Cox AL, Bailey JR, Pekosz A, Tobian AAR, Durand CM, Bridges ND, Larsen CP, Heeger PS, Segev DL; CPAT investigators. Persistent SARS-CoV-2-specific immune defects in kidney transplant recipients following third mRNA vaccine dose. Am J Transplant. 2023 Jun;23(6):744-758. doi: 10.1016/j.ajt.2023.03.014. Epub 2023 Mar 24.

    PubMed 36966905

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNT162b2 vaccine (Pfizer/BioNTech) and mRNA-1273 vaccine (Moderna) in people with Kidney Transplant Recipients, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 5 inclusion and 13 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 22 Jan 2024). 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?

Proportion of Recipients Who Achieve an Antibody Response >50 U/mL After the Third Dose of mRNA COVID-19 Vaccine (time frame: Outcome was measured at 30 days after study intervention (dose 3 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 NCT04969263, which also lists 3 linked publications.

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 30 Jul 2025.

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