COVID-19 Protection After Transplant Pilot Study

Kidney Transplant Recipients Clinical Trial

— CPAT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969263
• Other study ID #: DAIT COVID19-TB-02
• Secondary ID: NIAID CRMS ID#:
• Status: Completed
• Phase: Phase 2
• Start date: August 10, 2021
• Est. completion date: March 10, 2023

Study information

• Verified date: January 2024
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: March 10, 2023
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Kidney Transplant Recipients

Intervention

Biological:
• BNT162b2 vaccine (Pfizer/BioNTech)
30 microgram dose
• mRNA-1273 vaccine (Moderna)
100 microgram dose

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	PPD

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency of 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)
Secondary	Frequency of Any Serious Adverse Events (SAEs) to the Third Dose of an mRNA Vaccine	Safety measure status post third dose of mRNA vaccine	Through Day 30 Post-Vaccination (Dose 3)
Secondary	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)
Secondary	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)
Secondary	Proportion of Participants With Graft Loss	Safety measure status post third dose of mRNA vaccine.	Through Day 60 Post-Vaccination (Dose 3)
Secondary	Occurrence of Death Among Participants	Safety measure status post third dose of mRNA vaccine.	Through Day 60 Post-Vaccination (Dose 3)