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

NCT05142501 | Terminated

• 1 other identifier: HD-COVID-IR-EU
• Study Type: observational
• Target: 23
• Locations: 2 countries
• Sites: 11

Brief Summary

Observation of humoral and cellular immune response after additional dose vaccine with different COVID-19 vaccines in ESKD patients in hemodialysis therapy.

Conditions

Chronic Kidney Diseases; COVID-19; Hemodialysis

Keywords

Chronic Kidney Disease; COVID-19; Immune responses

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Blood samples OTHER

Four consecutive blood sampling throughout the overall follow-up period of 12 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Prevalent hemodialysis patients treated who receive three hemodialysis treatments per week.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead

Study Sites (11)

NephroCare Amadora

Amadora, 2700-391, Portugal

Location

NephroCare Restelo

Lisbon, 1400-195, Portugal

Location

NephroCare Lumiar

Lisbon, 1750-130, Portugal

Location

NephroCare Vila Franca de Xira

Vila Franca de Xira, 2600-076, Portugal

Location

Centro de Diálisis Barcelona - Glories

Barcelona, 08013, Spain

Location

Centro de Diálisis Barcelona - Rosselló

Barcelona, 08029, Spain

Location

Centro de Diálisis Granollers

Granollers, 08401, Spain

Location

Centro de Diálisis Dialcentro

Madrid, 28009, Spain

Location

Centro de Diálisis San Luciano

Madrid, 28041, Spain

Location

Centro de Diálisis Sant Boi

Sant Boi de Llobregat, 08830, Spain

Location

Centro de Diálisis Terrassa

Terrassa, 08223, Spain

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; COVID-19

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pedro Ponce, Dr

  Nephrocare Portugal

  PRINCIPAL INVESTIGATOR

• Maria Eva Baró Salvador, Dr

  Fresenius Medical Care España, S.A.U.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 2, 2021
• Study Start: April 25, 2022
• Primary Completion: September 2, 2022
• Study Completion: September 2, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (4); ES (7)