Immunological Safety and Effectiveness of the First Booster Dose of mRNA Vaccines Against COVID-19 in Kidney Transplant Recipients.

Institute for Clinical and Experimental Medicine

Status: Active, not recruiting

Conditions: COVID-19; Vaccine Adverse Reaction; Kidney Diseases; Rejection Acute Renal; Kidney Transplant; Complications; Rejection Chronic Renal

Treatments: Biological: Booster dose of mRNA vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT05483725

G-21-71

Details and patient eligibility

About

Prospective observational trial to assess immunological safety (anti-HLA antibodies, donor-derived cell-free DNA) and immunological effectiveness (anti-SARS-CoV-2 IgG) of the first booster dose of SARS-CoV-2 mRNA vaccines in kidney transplant recipients at least one year from transplantation.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Kidney transplant recipients followed at Institute for Clinical and Experimental Medicine (IKEM)
• vaccinated with 2 doses of mRNA vaccine (BNT-162b2 or mRNA-1273)
• immunosuppressive regimen includes or does not include mycophenolic acid or mycophenolate mofetil
• COVID naive

Exclusion criteria

• age < 18 years
• pregnant women, breastfeeding women
• unable/unwilling to give informed consent

Trial design

108 participants in 1 patient group

First booster dose group

Treatment:

Biological: Booster dose of mRNA vaccine