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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04757883
Acronym
COVATRHUS
Enrollment
37
Registered
2021-02-17
Start date
2021-02-02
Completion date
2024-11-01
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

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.

Interventions

OTHERStudy 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.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026