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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04828460
Recruitment Status : Recruiting
First Posted : April 2, 2021
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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
Covid19 Kidney Transplantation

Study Design
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Study Type : Observational
Estimated 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 : February 9, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Kidney transplant recipients who receive Covid-19 vaccine


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies [ Time Frame: One month after the 2nd injection of the COVID-19 vaccine ]

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Kidney transplant recipients followed in French transplant centers
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04828460


Contacts
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Contact: Sophie Ohlmann, MD 0369551320 ext 33 sophie.ohlmann@chru-strasbourg.fr

Locations
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France
Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Sophie Ohlmann, MD    0369551320 ext 33    sophie.ohlmann@chru-strasbourg.fr   
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04828460    
Other Study ID Numbers: 8133
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
covid19
kidney transplantation
seroconversion
immunosuppression
vaccination
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases