Clinical Trials Logo
  1. Home
  2. Covid19
  3. NCT05483725
  4. Details
NCT05483725 Clinical Trial

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

COVID-19 Clinical Trial

Official title:
Assessment of Association Between 3rd Dose of mRNA Vaccine and Risk of SARS-CoV-2 Infection in Kidney Transplant Recipients, Safety and Immunogenicity Assessment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05483725
Other study ID # G-21-71
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 4, 2021
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source Institute for Clinical and Experimental Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 108
Est. completion date December 31, 2024
Est. primary completion date December 4, 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Booster dose of mRNA vaccine
Administration of SARS-CoV-2 mRNA vaccine.

Locations
Country Name City State
Czechia Institute for Clinical and Experimental Medicine Praha

Sponsors (1)
Lead Sponsor Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
Primary 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 Immunological effectiveness - anti-SARS-CoV-2 antibodies Emergence or increase of anti-SARS-CoV-2 IgG. Comparison of anti-SARS-CoV-2 IgG assays at booster dose and three months later.
See also
  Status Clinical Trial Phase
Recruiting NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Active, not recruiting NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure