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

NCT05483725 | Active Not Recruiting FDA Drug

• 1 other identifier: G-21-71
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

kidney transplantation; COVID-19; mRNA vaccine; vaccine safety; alloreactivity

Outcome Measures

Primary Outcomes (2)

• Immunological safety - anti-HLA antibodies

  Emergence of de novo anti-HLA/donor specific antibodies, increase of preformed anti-HLA/donor specific antibodies above 50% of pre-booster level.

  Comparison of anti-HLA single antigen bead assays at booster dose and three months later.

• Immunological safety - donor-derived cell-free DNA

  Elevation of dd-cfDNA above 1% threshold

  Comparison of dd-cfDNA assays at booster dose and three months later.

Secondary Outcomes (1)

• Immunological effectiveness - anti-SARS-CoV-2 antibodies

  Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.

Study Arms (1)

First booster dose group

Biological: Booster dose of mRNA vaccine

Interventions

Booster dose of mRNA vaccine BIOLOGICAL

Administration of SARS-CoV-2 mRNA vaccine.

First booster dose group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients, vaccinated with 2 doses of mRNA vaccines against COVID, scheduled for the first booster dose.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Related Publications (2)

• Petr V, Zahradka I, Modos I, Roder M, Fialova M, Machkova J, Kabrtova K, Hruba P, Magicova M, Slavcev A, Striz I, Viklicky O. Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine Booster Doses in Kidney Transplant Recipients: Results of a 12-mo Follow-up From a Prospective Observational Study. Transplant Direct. 2024 May 17;10(6):e1645. doi: 10.1097/TXD.0000000000001645. eCollection 2024 Jun.

  PMID: 38769974 DERIVED

• Petr V, Zahradka I, Modos I, Roder M, Prewett A, Fialova M, Machkova J, Hruba P, Magicova M, Slavcev A, Striz I, Viklicky O. First Booster of SARS-COV-2 mRNA Vaccine Is Not Associated With Alloimmunization and Subclinical Injury of Kidney Allograft. Transplantation. 2023 Feb 1;107(2):e62-e64. doi: 10.1097/TP.0000000000004421. Epub 2022 Oct 29. No abstract available.

  PMID: 36314999 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples, four 5ml vials of blood, taken on day of booster dose and 3 months later.

MeSH Terms

Conditions

Kidney Diseases; COVID-19

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ondrej Viklicky, MD, PhD

  Head of Department of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Transplant Center, Head of the Department of Nephrology, Principle Investigator, Clinical Professor

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: October 4, 2021
• Primary Completion: December 4, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)