Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

Covid19 Clinical Trial

— COVATRANS  

Official title:

Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04828460
• Other study ID #: 8133
• Status: Recruiting
• Start date: February 9, 2021
• Est. completion date: February 2023

Study information

• Verified date: March 2021
• Source: University Hospital, Strasbourg, France
• Contact: Sophie Ohlmann, MD
• Phone: 0369551320
• Email: sophie.ohlmann[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Est. completion date: February 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Kidney Transplantation

Locations

Country	Name	City	State
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare the seroconversion between different vaccines		At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
Secondary	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.
Secondary	Describe the patients characteristics associated with seroconversion		At Month 24 after the 2nd injection of the COVID-19 vaccine
Secondary	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
Secondary	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