Clinical Trial – HBV Vaccine in Renal Failure Patients – 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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