NCT05142501

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Diseases
• COVID-19
• Hemodialysis

Interventions

Type	Name	Description
OTHER	Blood samples	Four consecutive blood sampling throughout the overall follow-up period of 12 months.

Timeline

• Start date: 2022-04-25
• Primary completion: 2022-09-02
• Completion: 2022-09-02
• First posted: 2021-12-02
• Last updated: 2022-09-15

Locations

11 sites across 2 countries: Portugal, Spain