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

Phase 3

Completed

• Conditions: kidney transplant; niertransplantatie; 10038430

• Registration Number: NL-OMON50602
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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. Capable of understanding the purpose and risks of the study, fully informed
and given written informed consent (signed informed consent form has been
obtained)

Additional inclusion criteria to be eligible for stratum A:
5. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor
(tacrolimus or cyclosporine), MMF/MPA, and prednisone
6. In case of tacrolimus treatment: last tacrolimus pre-dose level while on
current dosage above 4 *g/l
7. In case of cyclosporine treatment: last cyclosporine pre-dose level while on
current dosage above 75 *g/l
8. Prednisone dose at least 5 mg/day
9. First or second transplantation
10. Calculated level of panel reactive antibodies prior to last transplantation
below 85%
11. No signs of acute rejection during the preceding year

Exclusion Criteria

1. Multi-organ transplant recipient
2. Previous or active COVID-19 disease
3. Active malignancy, except non-melanoma skin cancer
4. Inherited immune deficiency
5. Infection with Human Immunodeficiency Virus (HIV)
6. Administration of T cell, B cell, or plasma cell depleting antibodies during
the last 6 months
7. Any vaccination within a month before enrolment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the percentage of subjects with a serum anti-S1 IgG<br /><br>concentration *10 BAU/mL at 28 days after the third vaccine administration.</p><br>