Clinical trial NCT04828460: Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients
Official title: Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Kidney Transplantation
Keywords: covid19
kidney transplantation
seroconversion
immunosuppression
vaccination
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-04-02
Enrollment: 3500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant recipients followed in French transplant centers

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
timeFrame: One month after the 2nd injection of the COVID-19 vaccine
Secondary outcomes:
measure: Compare the seroconversion between different vaccines
timeFrame: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
measure: Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
timeFrame: 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.
measure: Describe the patients characteristics associated with seroconversion
timeFrame: At Month 24 after the 2nd injection of the COVID-19 vaccine
measure: Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
timeFrame: At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
measure: Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
timeFrame: At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
References: