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Trial registered on ANZCTR


Registration number
ACTRN12618000631202
Ethics application status
Approved
Date submitted
8/04/2018
Date registered
20/04/2018
Date last updated
23/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial to assess antibody response to hepatitis B vaccine in patients with chronic kidney disease.
Scientific title
A randomised trial to assess antibody response to hepatitis B vaccine in patients with chronic kidney disease.
Secondary ID [1] 294531 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic kidney disease 307309 0
Vaccination 307310 0
Hepatitis B 307497 0
Condition category
Condition code
Renal and Urogenital 306420 306420 0 0
Kidney disease
Inflammatory and Immune System 306421 306421 0 0
Normal development and function of the immune system
Infection 306582 306582 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 300831 0
Prevention
Comparator / control treatment
Hepatitis B vaccination standard primary schedule, three doses of 20mcg IM at 0,1 and 4 months or 0,1, and 6 months.

Booster hepatitis B vaccine of 20mcg IM stat in individuals who had previously completed primary hepatitis B vaccination schedule.
Seasonal influenza vaccine.
Control group
Active

Outcomes
Primary outcome [1] 305435 0
The rate of seroconversion to hepatitis B vaccination (defined as detectable HBsAb >10 mIU/ml) in patients with chronic kidney disease.
Timepoint [1] 305435 0
4 weeks after completion of the primary hepatitis B vaccine schedule.
Secondary outcome [1] 345223 0
Plasmablast response as measured by flow cytometry.
Timepoint [1] 345223 0
7 days after vaccination with either the first dose of primary hepatitis B vaccination, booster hepatitis B vaccination, or seasonal influenza vaccination.
Secondary outcome [2] 345224 0
Activation of follicular helper T cells as measured by flow cytometry.
Timepoint [2] 345224 0
7 days after vaccination with either the first dose of primary hepatitis B vaccination, booster hepatitis B vaccination, or seasonal influenza vaccination.
Secondary outcome [3] 345226 0
Rate of seroconversion after booster hepatitis B vaccine (defined as detectable HBsAb >10 mIU/ml) in patients with CKD on haemodialysis, compared to healthy controls.
Timepoint [3] 345226 0
4 weeks after booster vaccine.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 10598 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 22315 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 299158 0
Hospital
Name [1] 299158 0
Canberra Hospital Private Practice Trust Fund
Address [1] 299158 0
The Canberra Hospital
PO Box 11
WODEN ACT 2605
Country [1] 299158 0
Australia
Funding source category [2] 299159 0
Government body
Name [2] 299159 0
National Health and Medical Research Council
Address [2] 299159 0
GPO Box 1421
Canberra ACT 2601
Country [2] 299159 0
Australia
Primary sponsor type
Individual
Name
Professor Matthew C Cook
Address
Department of Immunology
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 298414 0
Individual
Name [1] 298414 0
Dr Krishna Karpe
Address [1] 298414 0
Department of Renal Medicine
The Canberra Hospital
Yamba Drive
Garran ACT 2605
Country [1] 298414 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300083 0
The Canberra Hospital Human Research and Ethics Committee
Ethics committee address [1] 300083 0
The Canberra Hospital
Garran ACT 2605
Ethics committee country [1] 300083 0
Australia
Date submitted for ethics approval [1] 300083 0
Approval date [1] 300083 0
11/10/2010
Ethics approval number [1] 300083 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82510 0
Prof Matthew Cook
Address 82510 0
Department of Immunology
The Canberra Hospital
Yamba Drive
GARRAN ACT 2605
Country 82510 0
Australia
Phone 82510 0
+61 2 6244 2222
Fax 82510 0
Email 82510 0
Matthew.Cook@act.gov.au
Contact person for public queries
Name 82511 0
Prof Matthew Cook
Address 82511 0
Department of Immunology
The Canberra Hospital
Yamba Drive
GARRAN ACT 2605
Country 82511 0
Australia
Phone 82511 0
+61 2 6244 2222
Fax 82511 0
Email 82511 0
Matthew.Cook@act.gov.au
Contact person for scientific queries
Name 82512 0
Prof Matthew Cook
Address 82512 0
Department of Immunology
The Canberra Hospital
Yamba Drive
GARRAN ACT 2605
Country 82512 0
Australia
Phone 82512 0
+61 2 6244 2222
Fax 82512 0
Email 82512 0
Matthew.Cook@act.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary