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

NCT04757883 | Terminated

• 1 other identifier: 8135
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Recipients

Outcome Measures

Primary Outcomes (5)

• 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

Interventions

Study of the synthesis of antibodies directed against SARS OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

kidney transplants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Caillard Sophie

Strasbourg, 67000, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 17, 2021
• Study Start: February 2, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

FR (1)