None listed
Conditions
Brief summary
The purpose of the study is to compare two Hepatitis B vaccination (HBV) schedules of 40 µg at 0, 1, 2 and 6 months with schedule of 20 µg at 0, 1, 2 and 6 months in patients with stage 4 or 5 Chronic Kidney Disease (CKD), and the response to routine vaccination against influenza. The study will also examine responses to booster HBV in CKD patients who are receiving haemodialysis. This will enable us to determine the best way to vaccinate people with CKD against hepatitis B, and will provide us with information about changes that occur in the immune system in people with CKD.
Interventions
Study subjects requiring primary hepatitis B vaccination schedule were randomized to receive either four doses of 20mcg intramuscularly or four doses of 40mcg intramuscularly, at 0, 1, 2 and 6 months.
CKD patients and patients on dialysis who had previously completed primary hepatitis B vaccination schedule but required booster hepatitis B vaccination received a single dose of 40mcg intramuscularly. Healthy controls who had previously completed primary hepatitis B vaccination schedule but requi
Study subjects requiring primary hepatitis B vaccination schedule were randomized to receive either four doses of 20mcg intramuscularly or four doses of 40mcg intramuscularly, at 0, 1, 2 and 6 months. CKD patients and patients on dialysis who had previously completed primary hepatitis B vaccination schedule but required booster hepatitis B vaccination received a single dose of 40mcg intramuscularly. Healthy controls who had previously completed primary hepatitis B vaccination schedule but required booster hepatitis B vaccination received a single dose of 20mcg intramuscularly. All study participants who required seasonal influenza vaccine received 0.5ml of vaccine intramuscularly. For patients who received both hepatitis B vaccine (either first dose of primary schedule or booster vaccine) and influenza vaccine, they were administered more than 4 weeks apart. All vaccines were considered "one-off" events for recruitment. Repeated vaccinations eg. with seasonal influenza vaccine annually, was not specifically studied.
Sponsors
Professor Matthew C Cook
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients with stage 4 or 5 chronic kidney disease; requiring either hepatitis B vaccine or seasonal influenza vaccine for routine clinical care. Patients receiving haemodialysis for the treatment of chronic kidney disease requiring either booster hepatitis B vaccine or seasonal influenza vaccine for routine clinical care. Healthy controls requiring either primary hepatitis B vaccination, booster hepatitis B vaccination, or seasonal influenza vaccination.
Exclusion criteria
For patients with chronic kidney disease requiring primary hepatitis B vaccination (full schedule), exclusion criteria were dialysis or kidney transplant. For both patients with chronic kidney disease and healthy controls, other exclusion criteria were detectable hepatitis B surface antibody, previous hepatitis B infection, cancer, active infection, chronic inflammatory disease, immunosuppressive medication or immunodeficiency.
Outcome results
None listed