Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients
Recruiting
- Conditions
- Kidney Transplant Recipients
- Registration Number
- NCT04757883
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
The investigators goal is to assess the vaccine response of kidney transplant patients following vaccination against SARS-CoV-2.
The study population will be derived from cohorts of kidney transplant patients who have been transplanted for more than 3 months and have no contraindications to vaccination. These patients will be vaccinated as part of routine care with a CoV-2 SARS vaccine licensed in France.
In this cohort, the investigators wish to study the post-vaccination humoral response by assaying neutralizing antibodies against SARS CoV-2 and the specific cellular response of SARS Cov-2 by quantiferon and in vitro lymphocyte stimulation assays.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine. Month 24 after vaccination
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Caillard Sophie
🇫🇷Strasbourg, France