CClinicalTrials.gg
Status unknownNCT04828460COVATRANSUpdated Nov 9, 2021

Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients

An observational study in Covid19 and Kidney Transplantation, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2021-11-09.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,500
Sex
All
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Study 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.

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Conditions studied

  • Covid19
  • Kidney Transplantation

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Keywords

  • covid19
  • kidney transplantation
  • seroconversion
  • immunosuppression
  • vaccination
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 3,500 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 966 studies on the registry; 342 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Kidney transplant recipients followed in French transplant centers

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Kidney transplant recipients who receive Covid-19 vaccine
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What researchers measure

Primary outcomes

  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 outcomes

  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

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Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04828460
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Apr 2, 2021
Start date
Feb 9, 2021
Primary completion
Dec 2021 (estimated)
Completion
Feb 2023 (estimated)
Last update
Nov 9, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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