COVID-19 VaccinAtion in patients with chronic Kidney disease in New Zealand (C-VAK NZ study)

Not Applicable

• Conditions: Kidney Transplant; Dialysis; Covid-19; Renal and Urogenital - Kidney disease; Infection - Other infectious diseases

• Registration Number: ACTRN12621000460808
• Lead Sponsor: Auckland District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-20
• Last Update Posted: 26 April 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

oAdults aged 16 years and older.
oPatients with kidney failure on dialysis
oKidney-only and simultaneous pancreas kidney transplant recipients, who are at least 3 months post transplantation.
oPlanned to receive a vaccine for SARS-CoV-2

Exclusion Criteria

oPatients with current COVID-19 infection
oPatients with a proven current bacterial, viral, fungal or parasitic infection
oPregnant
oUnable to give informed consent
oRefuse to get vaccinated

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
humoral responses measured by<br>1. Serology for Covid 19 - positive antibody response post vaccination for humoral response<br>[1, 3 and 6 months post booster dose of vaccination];Cellular responses measured using T cell responses post vaccination <br>specific assay to be determined<br><br>At 3 weeks post booster dose of vaccination[3 weeks post vaccination]

Secondary Outcome Measures

Name	Time	Method
Acute rejection - will be assessed by kidney biopsy if graft dysfunction[Post vaccination for 3 months at 1,4,8, and 12 weeks after booster vaccination];HLA antibodies by luminex assays - these are done routinely in all patients on the transplant waitlist 3 monthly and will be assessed for 1 year post vacciantion<br>[post vaccination as above- 3 monthly for one year]