Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.
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
23
Four consecutive blood sampling throughout the overall follow-up period of 12 months.
NephroCare Amadora
Amadora, Portugal
NephroCare Restelo
Lisbon, Portugal
NephroCare Lumiar
Lisbon, Portugal
NephroCare Vila Franca de Xira
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.
Time frame: 12 months after start of study
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Vila Franca de Xira, Portugal
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
...and 1 more locations