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

NCT ID: NCT04757883

Last Updated: 2025-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-02

Study Completion Date

2024-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Recipients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caillard Sophie

Strasbourg, , France

Site Status

Countries

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France

Other Identifiers

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8135

Identifier Type: -

Identifier Source: org_study_id

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