Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

• Conditions: Covid19; Kidney Transplantation

• Registration Number: NCT04828460
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-09
• Status Verified: 2021-03
• Study First Submitted: 2021-03-31
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-02
• Last Update Submitted: 2021-11-04
• Last Update Posted: 2021-11-09
• Primary Completion: 2021-12
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
Describe the patients characteristics associated with seroconversion	At 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.
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

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France