None listed
Conditions
Brief summary
The RIVASTIM trials aim to identify strategies to improve immunological responses to a 3rd booster dose of the mRNA Pfizer Comirnaty COVID-19 vaccine in a cohort of kidney transplant patients who have failed to achieve an adequate immune response to a standard two-dose COVID-19 vaccine course. Kidney transplant patients are a highly vulnerable group of immunosuppressed patients who suffer from disproportionately high COVID-19-related morbidity and mortality. The dietary fibre supplement inulin shows promise in enhancing immune responses to vaccination. In this study kidney transplant patients will be randomised to either take inulin supplements or placebo. Four weeks after randomisation, participants will receive a 3rd COVID-19 vaccine dose, and immunological responses will be assessed 4-6 weeks later.
Interventions
Kidney transplant patients who are non- or low-responders to conventional 2-dose COVID-19 vaccination regimen will be randomised to receive 20g inulin daily, divided into 2 doses of 10g dissolved in 200mL water. For a week patients will take 10g daily in a single dose, uptitrating to 20g daily in 2 divided doses thereafter until the conclusion of the trial (8-10 weeks total therapy). Adherence will be monitored through return and weighing of unused supplement powder at conclusion of the trial. 4
Kidney transplant patients who are non- or low-responders to conventional 2-dose COVID-19 vaccination regimen will be randomised to receive 20g inulin daily, divided into 2 doses of 10g dissolved in 200mL water. For a week patients will take 10g daily in a single dose, uptitrating to 20g daily in 2 divided doses thereafter until the conclusion of the trial (8-10 weeks total therapy). Adherence will be monitored through return and weighing of unused supplement powder at conclusion of the trial. 4 weeks after randomisation patients will receive a 3rd COVID-19 mRNA vaccine (Pfizer Comirnaty) dose. All participants will receive COVID vaccination during a clinical trial visit to ensure adherence.
Sponsors
Professor P. Toby H Coates (MBBS FRACP PhD)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Kidney transplant recipients Aged 18-80 years Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have demonstrably not responded (undetectable anti-spike protein antibodies) or low response (anti-RBD antibody titre < 100 U/mL)
Exclusion criteria
Aged <18 years or >80 years Multi-organ transplant recipients (e.g. kidney-pancreas) Patients who are currently pregnant Patient has an underlying condition predisposing to increased gut permeability (including, but not limited to: active or recent within 6 weeks gastrointestinal infection, inflammatory bowel disease, short-gut syndrome, or coeliac disease) Have not received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have mounted an adequate immune response (anti-spike protein antibodies above detection threshold)
Outcome results
None listed