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Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

NCT ID: NCT04828460

Last Updated: 2021-11-09

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

UNKNOWN

Total Enrollment

3500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-09

Study Completion Date

2023-02-28

Brief Summary

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Vaccination against SARS CoV-2 appears to be the best strategy today to control the COVID-19 pandemic. The first published studies with Pfizer, Moderna and Astra-Zeneca vaccines show very good vaccine protection in the general population and good short-term tolerance. The efficacy of these vaccines ranges from 62 to 95%, which is particularly remarkable, especially for mRNA vaccines. Nevertheless, these studies do not report the vaccine response in organ transplant patients.

It is known that transplant patients have lower vaccine responses than immunocompetent patients due to some degree of immunosuppression.

Therefore, the investigators are interested in evaluating the vaccine response of organ transplant recipients after vaccination against SARS- CoV-2. For non-responder patients, new strategies can be proposed: 3rd or 4th boost of vaccine or perfusion/injection of antiS monoclonal antibodies. These strategies must be evaluated.

Detailed Description

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Conditions

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Covid19 Kidney Transplantation

Keywords

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covid19 kidney transplantation seroconversion immunosuppression vaccination

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Kidney transplant recipients who receive Covid-19 vaccine

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient, male or female, adult or child (15 years and older)
* Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the 2 injections
* Solid organ transplant recipient
* Transplantation for more than 3 months

Exclusion Criteria

* History of anaphylactic shock or known allergy to PEG
* Known history of COVID or positive Covid serology in the 3 months preceding inclusion
* Formal contraindication to an intra-muscular injection
* Impossibility to give the subject informed information (subject in emergency situation, difficulties in understanding the subject, ...)
* Subject under legal protection
* Subject under guardianship or curatorship
* Patient having expressed his opposition to participate
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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Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sophie Ohlmann, MD

Role: CONTACT

Phone: 0369551320

Email: [email protected]

Facility Contacts

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Sophie Ohlmann, MD

Role: primary

Other Identifiers

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8133

Identifier Type: -

Identifier Source: org_study_id