Vaccination of kidney transplant and dialysis patients and their close household contacts against COVID-19

Not Applicable

Completed

• Conditions: Kidney Transplant; Dialysis; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12621000532808
• Lead Sponsor: Central Adelaide Local Health Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-06
• Study Completion: 2021-11-30
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

For patient group:
Have a current kidney transplant >3 months or currently on dialysis.
Have a close household contact able to participate.

Exclusion Criteria

For patient group:
Prior exposure to SARS-CoV-2 (positive serology).
Have previously received a COVID-19 vaccination.
Due to receive a transplant within the ensuing 6 months.

Control/comparison group:
Prior exposure to SARS-CoV-2 (positive serology).
Have previously received a COVID-19 vaccination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Capacity of serum to neutralise SARS-CoV-2 spike protein-expressing pseudovirus will be assessed by a pseudovirus neutralisation assay.[Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.];Detectable seroconversion of IgG against SARS-CoV-2 spike protein and receptor-binding domain will be assessed by enzyme-linked immunosorbent assay. [Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.];SARS-CoV-2 spike protein-specific T cell response will be assessed by IFN-gamma ELISpot. [Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.]