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NCT05142501 Clinical Trial

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

COVID-19 Clinical Trial

— COVID-thIRd  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05142501
Other study ID # HD-COVID-IR-EU
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 25, 2022
Est. completion date September 2, 2022

Study information
Verified date September 2022
Source Fresenius Medical Care Deutschland GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 23
Est. completion date September 2, 2022
Est. primary completion date September 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Blood samples
Four consecutive blood sampling throughout the overall follow-up period of 12 months.

Locations
Country Name City State
Portugal NephroCare Amadora Amadora
Portugal NephroCare Lumiar Lisboa
Portugal NephroCare Restelo Lisboa
Portugal NephroCare Vila Franca de Xira Vila Franca De Xira
Spain Centro de Diálisis Barcelona - Glories Barcelona
Spain Centro de Diálisis Barcelona - Rosselló Barcelona
Spain Centro de Diálisis Granollers Granollers
Spain Centro de Diálisis Dialcentro Madrid
Spain Centro de Diálisis San Luciano Madrid
Spain Centro de Diálisis Sant Boi Sant Boi de Llobregat
Spain Centro de Diálisis Terrassa Terrassa

Sponsors (1)
Lead Sponsor Collaborator
Fresenius Medical Care Deutschland GmbH

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Humoral immune response 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
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