Clinical Trial â HBV Vaccine in Renal Failure Patients â Kidney Failure
The investigators propose a prospective, randomized study to compare the safety and immunogenicity of intradermal hepatitis B vaccination with a novel device with intramuscular in patients on renal replacement therapy.
The primary end point is the seroprotection rate of the HBVv at 12 months after the first dose of vaccination. The secondary end points are the seroprotection rate of HBVv and the geometric mean titre (GMT) fold increase of the anti-HBs at 1, 3, 6, 12 (GMT only) and 18 months after the first dose of vaccination. Adverse reactions of the vaccine will also be assessed immediately and for 1 month after vaccination.
| Study Type : | Interventional  (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Efficacy of Intradermal Hepatitis B Vaccine in Renal Failure Patients |
| Study Start Date : | January 2016 |
| Estimated Primary Completion Date : | December 2018 |
| Estimated Study Completion Date : | March 2019 |
Contacts
| Contact: Ivan FN Hung, MD FRCP | 22554049 | ivanhung@hku.hk | |
| Contact: Kelvin To, MD | 22553111 | kelvinto@hku.hk |
| ClinicalTrials.gov Identifier: | NCT02621112 |
For enrollment please visit www.clinicaltrials.gov.
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