Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients

Phase 1

• Conditions: COVID-19 is associated with severely increased morbidity and mortality in kidney transplant patients. Available data show that the immune response after a standard regimen of two mRNA vaccinations is severely attenuated in kidney transplant patients compared to controls, especially when their immunosuppressive regimen contains mycophenolate mofetil (MMF) / mycophenolic acid (MPA).; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 100000004865; MedDRA version: 23.1Level: LLTClassification code 10084508Term: COVID-19 antibody testSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: PTClassification code 10023439Term: Kidney transplant rejectionSystem Organ Class: 10021428 - Immune system disorders; MedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 100000004865; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 100000004865

• Registration Number: EUCTR2021-004558-44-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-13
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

1. Age 18 years or older
2. Received 2 doses of mRNA-1273 according to the recommended vaccination schedule, with the last administration within the last nine months
3. Insufficient response to vaccination, defined as anti-spike IgG in serum < 10 BAU/mL measured between 25 and 56 days after the second dose of the mRNA-1273 vaccine with a validated test
4. Eligible for COVID-19 vaccination as described by the instructions of the manufacturers of the vaccine (Moderna and Janssen)
5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
6. Willing to adhere to the protocol and be available during the study period

Additional inclusion criteria to be eligible for stratum A:
7. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor (tacrolimus or cyclosporine), MMF/MPA, and prednisone
8. In case of tacrolimus treatment: last tacrolimus pre-dose level while on current dosage above 4 µg/l
9. In case of cyclosporine treatment: last cyclosporine pre-dose level while on current dosage above 75 µg/l
10. Prednisone dose at least 5 mg/day
11. First or second transplantation
12. Calculated level of panel reactive antibodies prior to last transplantation below 85%
13. No signs of acute rejection during the preceding year
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1. Multi-organ transplant recipient
2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
3. Previous or active COVID-19 disease
4. Active malignancy, except non-melanoma skin cancer
5. Inherited immune deficiency
6. Infection with Human Immunodeficiency Virus (HIV)
7. Administration of T cell, B cell, or plasma cell depleting antibodies during the last 6 months
8. Any vaccination within a month before enrolment
9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified