Clinical trial NCT05142501: Observation of the Immune Response After COVID-19 Additional Vaccine Doses in Chronic Patients in Hemodialysis Therapy
Official title: Observation of Humoral and Cellular Immune Response After Additional Vaccine Dose With Different COVID-19 Vaccines in ESKD Patients in Hemodialysis Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Kidney Diseases
COVID-19
Hemodialysis
Keywords: Chronic Kidney Disease
COVID-19
Immune responses
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2021-12-02
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prevalent hemodialysis patients treated who receive three hemodialysis treatments per week.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Humoral immune response
timeFrame: 12 months after start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Amadora
country: Portugal
facility: NephroCare Amadora
city: Lisboa
country: Portugal
facility: NephroCare Restelo
city: Lisboa
country: Portugal
facility: NephroCare Lumiar
city: Vila Franca De Xira
country: Portugal
facility: NephroCare Vila Franca de Xira
city: Barcelona
country: Spain
facility: Centro de Diálisis Barcelona - Glories
city: Barcelona
country: Spain
facility: Centro de Diálisis Barcelona - Rosselló
city: Granollers
country: Spain
facility: Centro de Diálisis Granollers
city: Madrid
country: Spain
facility: Centro de Diálisis Dialcentro
city: Madrid
country: Spain
facility: Centro de Diálisis San Luciano
city: Sant Boi de Llobregat
country: Spain
facility: Centro de Diálisis Sant Boi
city: Terrassa
country: Spain
facility: Centro de Diálisis Terrassa
Study officials:
affiliation: Nephrocare Portugal
name: Pedro Ponce, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Fresenius Medical Care España, S.A.U.
name: Maria Eva Baró Salvador, Dr
role: PRINCIPAL_INVESTIGATOR
References: