Assessing vaccine response in kidney transplant patients after COVID-19 vaccination
Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients
This study is testing how well kidney transplant patients respond to the COVID-19 vaccine to understand their immune reaction better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT04757883 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the immune response of kidney transplant recipients following their vaccination against SARS-CoV-2. Participants will include individuals who have undergone kidney transplantation for more than three months and are receiving the vaccine as part of routine care. The study will analyze both the humoral response by measuring neutralizing antibodies and the cellular response through specific assays. The goal is to better understand how this patient population responds to the COVID-19 vaccine.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney or pancreatic kidney transplant recipients who are at least 18 years old and have been transplanted for more than three months.
Not a fit: Patients with a history of anaphylactic shock to PEG, known COVID-19 infection within three months prior to vaccination, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of COVID-19 vaccines in kidney transplant recipients, potentially guiding vaccination strategies for this vulnerable group.
How similar studies have performed: Other studies have shown varying responses to COVID-19 vaccines in immunocompromised populations, indicating that this area of research is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female, 18 years of age or older * Patient vaccinated against SARS-CoV-2 as part of routine care * Kidney or pancreatic kidney transplant * Transplantation for more than 3 months * Subject affiliated to a social protection health insurance * Subject able to understand the objectives and risks of the research and to give signed and dated informed consent Exclusion Criteria: * History of anaphylactic shock or known allergy to PEG * Known history of COVID or positive Covid serology in the 3 months prior to vaccination * Contraindication to an intramuscular injection * Impossibility to give informed information about the subject (subject in an emergency situation, difficulties in understanding the subject, ...) * Subject under safeguard of justice * Subject under guardianship
Where this trial is running
Strasbourg
- Caillard Sophie — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sophie Caillard, MD
- Email: sophie.caillard@chru-strasboourg.fr
- Phone: 003388116768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.