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

Terminated

• Conditions: COVID-19; Hemodialysis; Chronic Kidney Diseases

• Registration Number: NCT05142501
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-12-01
• Study First Submitted QC: 2021-12-01
• Study First Posted: 2021-12-02
• Study Start: 2022-04-25
• Status Verified: 2022-09
• Primary Completion: 2022-09-02
• Study Completion: 2022-09-02
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral immune response	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.

Trial Locations

Locations (11)

NephroCare Restelo; 🇵🇹 Lisboa, Portugal

NephroCare Amadora; 🇵🇹 Amadora, Portugal

Centro de Diálisis Dialcentro; 🇪🇸 Madrid, Spain

NephroCare Lumiar; 🇵🇹 Lisboa, Portugal

NephroCare Vila Franca de Xira; 🇵🇹 Vila Franca De Xira, Portugal

Centro de Diálisis Barcelona - Glories; 🇪🇸 Barcelona, Spain

Centro de Diálisis Barcelona - Rosselló; 🇪🇸 Barcelona, Spain

Centro de Diálisis San Luciano; 🇪🇸 Madrid, Spain

Centro de Diálisis Sant Boi; 🇪🇸 Sant Boi de Llobregat, Spain

Centro de Diálisis Granollers; 🇪🇸 Granollers, Spain

Centro de Diálisis Terrassa; 🇪🇸 Terrassa, Spain