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- Klinische proef NCT04828460
Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients (COVATRANS)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Verwacht)
Contacten en locaties
Studie Locaties
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Strasbourg, Frankrijk, 67000
- Werving
- Hôpitaux Universitaires de Strasbourg
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Contact:
- Sophie Ohlmann, MD
- Telefoonnummer: 33 0369551320
- E-mail: sophie.ohlmann@chru-strasbourg.fr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Kidney transplant recipients who receive Covid-19 vaccine
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Tijdsspanne: One month after the 2nd injection of the COVID-19 vaccine
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One month after the 2nd injection of the COVID-19 vaccine
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Compare the seroconversion between different vaccines
Tijdsspanne: At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
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At Month 3, Month 6, Month12 and Month 24 after the 2nd injection of the COVID-19 vaccine
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Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies
Tijdsspanne: 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.
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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.
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Describe the patients characteristics associated with seroconversion
Tijdsspanne: At Month 24 after the 2nd injection of the COVID-19 vaccine
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At Month 24 after the 2nd injection of the COVID-19 vaccine
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Assess the tolerance of the 3rd and 4th doses of vaccine in transplant patients
Tijdsspanne: At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
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At the day of injection, Month 1, Month 2, Month 3, Month 6 and Month 12 post injection
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Percentage of patients who develop a Seroconversion for SARS Cov-2 anti Spike and anti N antibodies after injection of monoclonal antibodies
Tijdsspanne: At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
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At Month 1, Week 6, Week 8, Month 3, Month 6 and Month 12 afin injection of monoclonal antibodies
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 8133
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Covid19
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Henry Ford Health SystemVoltooid
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Ricardo Pereira MestreInstitute of Oncology Research (IOR); Istituto Cantonale di PatologiaVoltooid
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Instituto de Investigación Hospital Universitario...Instituto de Salud Carlos III; Spanish Clinical Research Network - SCReNActief, niet wervend
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Inmunova S.A.Hospital Italiano de Buenos Aires; Laboratorio Elea Phoenix S.A.; Hospital de Campaña... en andere medewerkersVoltooid
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Manchester University NHS Foundation TrustUniversity of ManchesterVoltooid
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Rush University Medical CenterHospital Civil de GuadalajaraVoltooidCovid19Verenigde Staten, Mexico
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Evelyne D.TrottierVoltooid
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Sinovac Research and Development Co., Ltd.Voltooid
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Mabwell (Shanghai) Bioscience Co., Ltd.Shanghai Public Health Clinical CenterVoltooid
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Anavasi DiagnosticsNog niet aan het werven