COVID-19 Protection After Transplant Pilot Study (CPAT)

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Recipients
• Intervention / Treatment: Biological: mRNA-1273 vaccine (Moderna); Biological: BNT162b2 vaccine (Pfizer/BioNTech)

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Individuals who meet all the following criteria are eligible for enrollment as study participants-

1. Able to understand and provide informed consent;
2. Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment;
3. 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,
4. 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.

Exclusion Criteria:

Individuals who meet any of these criteria are not eligible for enrollment as study participants-

1. 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;
2. Known history of severe allergic reaction to any component of either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine;
3. Thrombotic events, myocarditis, or pericarditis temporally associated with prior dose of COVID-19 vaccine;
4. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months;
5. Significant graft dysfunction;
6. Receipt of any cellular depleting agent (e.g. ATG, Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment;
7. Receiving systemic immunomodulatory medication(s) for any condition other than transplant;
8. Any untreated active infection, including BK viremia >10^4 copies;
9. Infection with human immunodeficiency virus (HIV);
10. Maintenance immunosuppressive regimen that includes belatacept or abatacept;
11. Recent (within one year) or ongoing treatment for malignancy; or
12. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: mRNA-1273 vaccine (Moderna); The 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.	Biological: mRNA-1273 vaccine (Moderna); 100 microgram dose; Other Names: Moderna COVID-19 vaccine; SARS-CoV-2 mRNA vaccine; SPIKEVAX (COVID-19 vaccine, mRNA)
Experimental: BNT162b2 mRNA-based vaccine (Pfizer/BioNTech); The 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.	Biological: BNT162b2 vaccine (Pfizer/BioNTech); 30 microgram dose; Other Names: Pfizer-BioNTech COVID-19 vaccine; COMIRNATY (COVID-19 vaccine, mRNA); SARS-CoV-2 mRNA vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Outcome was measured at 30 days after study intervention (dose 3 vaccination)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through Day 60 Post-Vaccination (Dose 3)
Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody	Safety measure status post third dose of mRNA vaccine	Through Day 90 Post-Vaccination (Dose 3)
Proportion of Participants With Graft Loss	Safety measure status post third dose of mRNA vaccine.	Through Day 60 Post-Vaccination (Dose 3)
Occurrence of Death Among Participants	Safety measure status post third dose of mRNA vaccine.	Through Day 60 Post-Vaccination (Dose 3)
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	Through Day 7 Post-Vaccination (Dose 3)
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	Through Day 30 Post-Vaccination (Dose 3)

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: PPD Development, LP
• Investigators: Study Chair: Dorry L. Segev, MD, PhD, Department of Surgery, NYU Grossman School of Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2021
• Primary Completion (Actual): November 10, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: COVID-19 vaccine; SARS-CoV-2 antibody response
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: DAIT COVID19-TB-02; NIAID CRMS ID#: 38865 (Other Identifier: DAIT NIAID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: On average, within 24 months after database lock for the trial.
• IPD Sharing Access Criteria: Open access.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No