Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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.

Official Title
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Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients

Conditions
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Kidney Transplant Recipients

Intervention / Treatment
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* Other: Study of the synthesis of antibodies directed against SARS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Study of the synthesis of antibodies directed against SARS|Between 5 mL and 45 mL of additional blood will be collected to study the synthesis of antibodies against CoV-2 SARS and to investigate whether specialised immune cells also show an effective response against the virus.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 1 after vaccination | 
| 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 3 after vaccination | 
| 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 6 after vaccination | 
| 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 12 after vaccination | 
| 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 |