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
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• COVID-19
• Hemodialysis
• Kidney Diseases
• Renal Insufficiency, Chronic

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