COVATRANS: Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04828460

Collaborator

(none)

3,500

Enrollment

Location

23.7

Anticipated Duration (Months)

147.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Kidney Transplantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

3500 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

Actual Study Start Date :

Feb 9, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Kidney transplant recipients who receive Covid-19 vaccine

Outcome Measures

Primary Outcome Measures

Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies [One month after the 2nd injection of the COVID-19 vaccine]

Secondary Outcome Measures

Compare the seroconversion between different vaccines [At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine]
Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies [At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine and at Month 1 after the 3rd and 4th injection.]
Describe the patients characteristics associated with seroconversion [At Month 24 after the 2nd injection of the COVID-19 vaccine]
Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients [At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection]
Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies [At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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