None listed
Conditions
Brief summary
This study aims to measure the efficacy of the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) and BNT162b2 mRNA (Pfizer-BioNTech) COVID-19 vaccines in transplant recipients and patients on dialysis, and in their close household contacts. Early reports indicate that kidney transplant recipients receiving immunosuppressive medications have a reduced protective immune response to COVID-19 vaccines. This is of concern as these are the individuals most at risk. These patient groups are adept at avoiding exposure to pathogens out in the world, and are therefore most likely to be exposed to the SARS-CoV-2 virus via a close household contact e.g. a spouse. In this study, transplant recipients and dialysis patients will receive their vaccination at the same time as a close household contact. By comparing the immune response of patient and cohabitant, we will develop an understanding of whether priority vaccination of household contacts is a worthwhile strategy for protecting transplant and dialysis patients from COVID-19 in the future.
Interventions
Immune responses in kidney transplant and dialysis patients are compared in each case with that of a close household contact (usually a spouse) over the age of 18.
This study is interventional in so much as close household contacts of transplant and dialysis patients will, in some instances, receive their vaccinations earlier than they otherwise would.
Both patients and cohabitants will be asked to provide up to four blood samples starting prior to-, and then up to 6 months post-, receipt of t
Immune responses in kidney transplant and dialysis patients are compared in each case with that of a close household contact (usually a spouse) over the age of 18. This study is interventional in so much as close household contacts of transplant and dialysis patients will, in some instances, receive their vaccinations earlier than they otherwise would. Both patients and cohabitants will be asked to provide up to four blood samples starting prior to-, and then up to 6 months post-, receipt of the initial ChAdOx1 nCoV-19 (Oxford-AstraZeneca) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Blood samples will be collected at the Royal Adelaide Hospital by trained staff. Samples for some participants will be collected at the Queen Elizabeth Hospital or at SA Pathology collection centres as dictated by convenience. Number and timing of vaccine doses received will not differ from that of the rest of the population i.e. an initial and booster dose, 21 days apart in the case of Pfizer-BioNTech and 12 weeks apart in the case of Oxford-AstraZeneca. Participants will also be asked to provide a one-off stool sample prior to vaccination using a provided at-home collection kit. In conjunction with this, participants will be asked to complete a four-day food diary. Participation in this study will amount to four appointments for blood collection, and two visits to vaccination clinics.
Sponsors
Central Adelaide Local Health Network
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Outcome results
None listed