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COVID-19 Protection After Transplant Pilot Study (CPAT)

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ClinicalTrials.gov Identifier: NCT04969263
Recruitment Status : Active, not recruiting
First Posted : July 20, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Kidney Transplant Recipients Biological: mRNA-1273 vaccine (Pfizer/BioNTech) Biological: mRNA-1273 vaccine (Moderna) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label, non-randomized.
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : August 10, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mRNA-1273 vaccine (Pfizer/BioNTech)

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 Pfizer/BioNTech will receive a third dose of the the same vaccine.

Administration: One dose administered intramuscularly, upper arm.

Biological: mRNA-1273 vaccine (Pfizer/BioNTech)
30 microgram dose
Other Names:
  • BNT162b2 vaccine
  • SARS-CoV-2 RNA vaccine
  • Pfizer-BioNTech COVID-19 vaccine

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:
  • SARS-CoV-2 RNA vaccine
  • Moderna COVID-19 vaccine




Primary Outcome Measures :
  1. Proportion of Participants Who Achieve an Antibody Response >50 U/mL [ Time Frame: Day 30 Post-Vaccination (Dose 3) ]
    Efficacy measure status post third mRNA-1273 vaccination.


Secondary Outcome Measures :
  1. Frequency of Solicited Local Reactogenicity Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine [ Time Frame: Through Day 7 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  2. Frequency of Solicited Local Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine [ Time Frame: Through Day 7 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  3. Frequency of Solicited Systemic Reactogenicity Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine [ Time Frame: Through Day 7 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  4. Frequency of Solicited Systemic Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine [ Time Frame: Through Day 7 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  5. Frequency of Any Serious Adverse Events (SAEs) [ Time Frame: Through Day 30 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  6. Frequency of Any Unsolicited Adverse Events (AEs) [ Time Frame: Through Day 30 Post-Vaccination (Dose 3) ]
    Safety measure. An AE associated with the third dose of vaccine and/or study mandated procedures.

  7. Frequency of Any Serious Adverse Events (SAEs) [ Time Frame: Through Day 60 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  8. Frequency of Any Serious Adverse Events (SAEs) [ Time Frame: Through Day 365 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  9. Frequency of Any Unsolicited Adverse Events (AEs) [ Time Frame: Through Day 365 Post-Vaccination (Dose 3) ]
    Safety measure. An AE associated with the third dose of vaccine and/or study mandated procedures.

  10. Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection [ Time Frame: Through Day 60 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  11. Proportion of Participants who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody [ Time Frame: Through Day 60 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  12. Proportion of Participants with Graft Loss [ Time Frame: Through Day 60 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.

  13. Occurrence of Death Among Participants [ Time Frame: Through Day 60 Post-Vaccination (Dose 3) ]
    Safety measure status post third mRNA-1273 vaccination.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04969263


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
PPD
Investigators
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Study Chair: Dorry L. Segev, MD, PhD Department of Surgery, Johns Hopkins University School of Medicine
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04969263    
Other Study ID Numbers: DAIT COVID19-TB-02
NIAID CRMS ID#: 38865 ( Other Identifier: DAIT NIAID )
First Posted: July 20, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: On average, within 24 months after database lock for the trial.
Access Criteria: Open access.
URL: https://www.immport.org/home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
COVID-19 vaccine
SARS-CoV-2 antibody response
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs