HBV Vaccine in Renal Failure Patients
Renal Failure
About this trial
This is an interventional prevention trial for Renal Failure
Eligibility Criteria
Inclusion Criteria:
- Patients recruited have to be aged ≥ 21 years, with history of chronic renal failure and on renal replacement therapy (continuous ambulatory peritoneal dialysis or hemodialysis).
- All patients have to give written informed consent and will have up to 1 week period to decide.
- Subjects must be available to complete the study and comply with study procedures.
- Patients are willing to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
- All recruited subjects have to be HBsAg, anti-HBs and anti-HIV negative before recruitment.
Exclusion Criteria:
- Inability to comprehend and to follow all required study procedures
- History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
- Have a recent history (documented, confirmed or suspected) of a flu-like disease within a week of vaccination.
- Have a known allergy to components of the Study Vaccines.
- Have a positive urine or serum pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding.
- Have an active neoplastic disease or a history of any hematologic malignancy.
- Have known chronic active hepatitis B and hepatitis C (HBsAg+ve and anti-HCV+ve).
- Have known active human immunodeficiency virus (HIV).
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study.
- Unwilling to refuse participation in another clinical study through the end of this study.
- Axillary temperature ≥ 38°C or oral temperature ≥ 38.5°C within 3 days of intended study vaccination.
- Have a history of alcohol or drug abuse in the last 5 years.
- Have any condition that the investigator believes may interfere with successful completion of the study.
Sites / Locations
- University of Hong Kong, Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Intradermal HBVv with imiquimod
Intradermal HBVv with aqueous cream
Intramuscular HBVv with aqueous cream
Intradermal hepatitis B vaccination with topical imiquimod pretreatment. Subjects to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical imiquimod ointment pretreatment 5 minutes before injection at 0, 1, 3, 6 months
Intradermal hepatitis B vaccination with topical aqueous cream. Subjects to receive intradermal 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical aqueous cream pretreatment 5 minutes before injection at 0, 1, 3, 6 months
Intramuscular hepatitis B vaccination with topical aqueous cream. Subjects to receive intramuscular 10mcg of recombinant hepatitis B vaccine at two separate sites (5mcg) with topical aqueous cream pretreatment 5 minutes before injection at 0, 1, 3, 6 months