Clinical trial NCT04757883: Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients
Official title: Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Recipients
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: kidney transplants

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Month 1 after vaccination
measure: 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.
timeFrame: Month 3 after vaccination
measure: 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.
timeFrame: Month 6 after vaccination
measure: 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.
timeFrame: Month 12 after vaccination
measure: 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.
timeFrame: Month 24 after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Caillard Sophie
Study officials:
References: