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

Kidney Transplant Recipients Clinical Trial

— COVATRHUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757883
• Other study ID #: 8135
• Status: Recruiting
• Start date: February 2, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Sophie Caillard, MD
• Phone: 003388116768
• Email: sophie.caillard[@]chru-strasboourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

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.

Locations

Country	Name	City	State
France	Caillard Sophie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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