Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

NCT04828460 | Unknown

• 1 other identifier: 8133
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Kidney Transplantation

Keywords

covid19; kidney transplantation; seroconversion; immunosuppression; vaccination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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.

• Describe the patients characteristics associated with seroconversion

  At Month 24 after the 2nd injection of the COVID-19 vaccine

• 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

• 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

Study Arms (1)

Kidney transplant recipients who receive Covid-19 vaccine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Kidney transplant recipients followed in French transplant centers

You may qualify if:

• 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

You may not qualify if:

• History of anaphylactic shock or known allergy to PEG
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

MeSH Terms

Conditions

COVID-19; HIV Seropositivity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Sophie Ohlmann, MD

CONTACT

0369551320; sophie.ohlmann@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 2, 2021
• Study Start: February 9, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-03

Locations

FR (1)