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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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05142501
Study type Observational
Source Fresenius Medical Care Deutschland GmbH
Contact
Status Terminated
Phase
Start date April 25, 2022
Completion date September 2, 2022

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