Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in Hemodialysis Therapy (COVID-thIRd)

September 13, 2022 updated by: Fresenius Medical Care Deutschland GmbH

Observation of Humoral and Cellular Immune Response After Additional Vaccine Dose With Different COVID-19 Vaccines in ESKD Patients in Hemodialysis Therapy

Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In this open, prospective, observational trial the humoral and cellular immune response in ESKD patients undergoing hemodialysis shall be analyzed after administration of a fourth dose of vaccine. The total follow-up time per patient is up to 12 months after the fourth dose of vaccine.

In total, 340 patients (170 patients per country) shall be included. Only adult patients capable of giving consent will be enrolled. The humoral immune response will be analyzed in all patients, whereas the analysis of the cellular immune response will only be conducted in 15% of the enrolled patients.

The HD-COVID-IR-EU study shall be conducted in Portugal and in Spain.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Amadora, Portugal, 2700-391
        • NephroCare Amadora
      • Lisboa, Portugal, 1400-195
        • NephroCare Restelo
      • Lisboa, Portugal, 1750-130
        • NephroCare Lumiar
      • Vila Franca De Xira, Portugal, 2600-076
        • NephroCare Vila Franca de Xira
  • Spain
      • Barcelona, Spain, 08013
        • Centro de Diálisis Barcelona - Glories
      • Barcelona, Spain, 08029
        • Centro de Diálisis Barcelona - Rosselló
      • Granollers, Spain, 08401
        • Centro de Diálisis Granollers
      • Madrid, Spain, 28009
        • Centro de Diálisis Dialcentro
      • Madrid, Spain, 28041
        • Centro de Diálisis San Luciano
      • Sant Boi de Llobregat, Spain, 08830
        • Centro de Diálisis Sant Boi
      • Terrassa, Spain, 08223
        • Centro de Diálisis Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Prevalent hemodialysis patients treated who receive three hemodialysis treatments per week.

Description

Inclusion Criteria:

  • Informed consent signed and dated by study patient and investigator/authorized physician
  • Minimum age of 18 years
  • Ability to understand the nature and requirements of the study
  • ESKD patients on maintenance hemodialysis with a minimum of 4hrs three times a week at the time of recruitment and a dialysis vintage ≥3 months in NC clinics
  • Patients that already received three doses against COVID-19 as detailed in the manufacturer's instructions
  • Patients that are scheduled to receive a fourth vaccine dose of either Comirnaty (BioNTech/Pfizer) or Spikevax (Moderna) after approval of respective national authority.

Exclusion Criteria:

  • Any conditions which could interfere with the patient's ability to comply with the study
  • Participation in an interventional clinical study during the preceding 30 days
  • Previous participation in the same study
  • Patients with proven current COVID-19 infection as identified by routine clinical practice
  • Patient in therapy with immunosuppressive medications / immunomodulators
  • Patients who already received a fourth COVID-19 vaccination dose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral immune response
Time Frame: 12 months after start of study
The humoral immune response will be assessed at four different timepoints (Sample 1: prior to the fourth vaccine dose; sample 2: 1 months after the fourth vaccine dose; sample 3: 6 months after the fourth vaccine dose; sample 4: 12 months after the fourth vaccine dose or max. 4 weeks prior to the fifth vaccine dose, whichever comes first) through the measurement of the titers of Bioplex IgG antibody panel in study participant's blood samples.
12 months after start of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Investigators

  • Principal Investigator: Pedro Ponce, Dr, Nephrocare Portugal
  • Principal Investigator: Maria Eva Baró Salvador, Dr, Fresenius Medical Care España, S.A.U.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2022

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

September 2, 2022

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-COVID-IR-EU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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