Phenotyping Seroconversion Following Vaccination Against COVID-19 in Patients on Haemodialysis Study

NCT04815850 | Completed Results DMC

• 1 other identifier: 0810
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Patients on haemodialysis are at higher risk of getting a severe form of COVID-19 if they become infected. Vaccinations are soon to arrive and offer great hope of controlling the current pandemic. It is likely that patients on haemodialysis will be amongst the first people to be offered vaccination against COVID-19 when they become available. While any vaccines offered to these patients will be safe to receive, the effectiveness of the vaccines at giving immunity to being infected with COVID-19 are not known as they have not been explicitly tested in patients on haemodialysis. This study will involve having 3 blood tests to test for an antibody response following vaccination for COVID-19. The first will be 1 month after the first vaccination dose to look at the initial antibody response and the second and third will be 1 month and 6 months after the second vaccination dose.

Conditions

End Stage Kidney Disease

Keywords

haemodialysis; COVID-19; seroconversion; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Change in COVID-19 IgG Antibody (Relative Light Units)

  Measured from a serum blood sample. Serum was tested for the presence of SARS-CoV-2 neutralising IgG and IgM antibodies directed against the receptor binding domain of the S1 spike protein, using the Siemens ADVIA Centaur XP/XPT assay and reported as positive or negative as per manufacturer guidelines (detectable antibody levels \>1RLU (relative light units) reported as positive to an upper limit of 10)

  1 month post first vaccine

Study Arms (2)

Patients on haemodialysis

Patients receiving haemodialysis

Healthy controls

Participants with no chronic kidney disease or history of immunosuppression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving haemodialysis at Leicester General Hospital.

You may qualify if:

• End stage kidney disease on haemodialysis
• Able and willing to give informed consent
• Have completed or due to complete vaccination against COVID-19

You may not qualify if:

• Acute kidney injury requiring temporary haemodialysis
• Unable to give informed consent
• Pregnancy

Sponsors & Collaborators

• University of Leicester: lead
• Leicester Hospitals Charity: collaborator
• Francis Crick Institute: collaborator

Study Sites (1)

University Hospital Leicester NHS Trust

Leicester, Leicestershire, LE5 4PW, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; COVID-19; HIV Seropositivity; Renal Insufficiency, Chronic

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; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr Matthew Graham-Brown
• Organization: University of Leicester

mgb23@le.ac.uk

01162588043

Study Officials

• Matthew PM Graham-Brown

  University of Leicester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: March 1, 2021
• Primary Completion: February 15, 2022
• Study Completion: December 5, 2022
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2022-05

Locations

GB (1)