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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000460808
Acronym
C-VAK NZ study
Enrollment
600
Registered
2021-04-20
Start date
2021-06-01
Completion date
2022-02-01
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an observational cohort study assessing the serological response to COVID-19 vaccination in kidney and kidney pancreas transplant recipients and patients treated with maintenance dialysis at Auckland City Hospital. Three analyses will be undertaken: 1. Vaccine immunogenicity based on humoral and cellular responses. Serological testing for the antibody to SARS-CoV-2 will be done prior to vaccination and again at 1 and 3 weeks and 6 months after the booster vaccination in dialysis and transplant recipients. Cellular responses will be assessed at 3 weeks after the booster vaccination. 2. Development of anti-HLA antibodies in dialysis patients on the kidney transplant waiting list in the first 12 months after vaccination. 3. Development of acute rejection episodes at 1, 4, 8 and 12 weeks after vaccination in recipients of kidney and kidney-pancreas transplants.

Interventions

Assessment of serology for Covid -19 vaccination in kidney transplant and dialysis patients Testing at 1 and 3 weeks post Covid Vaccination and 6 months post covid vaccination follow up for one year with graft survival

Sponsors

Auckland District Health Board
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

o Adults aged 16 years and older. o Patients with kidney failure on dialysis o Kidney-only and simultaneous pancreas kidney transplant recipients, who are at least 3 months post transplantation. o Planned to receive a vaccine for SARS-CoV-2

Exclusion criteria

o Patients with current COVID-19 infection o Patients with a proven current bacterial, viral, fungal or parasitic infection o Pregnant o Unable to give informed consent o Refuse to get vaccinated

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026