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OpenTrials
Terminated

NCT Number: NCT04757883

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

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.

Why the study stopped: the required number of patients has been reached
Terminated

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Key information

Conditions

Kidney Transplant Recipients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caillard Sophie

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: Month 1 after vaccination

  2. 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.

    Time frame: Month 3 after vaccination

  3. 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.

    Time frame: Month 6 after vaccination

  4. 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.

    Time frame: Month 12 after vaccination

  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.

    Time frame: Month 24 after vaccination

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: COVATRHUS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 17, 2021
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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