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 :
||Triple (Participant, Investigator, Outcomes Assessor)
||Efficacy of Intradermal Hepatitis B Vaccine in Renal Failure Patients
|Study Start Date :
|Estimated Primary Completion Date :
|Estimated Study Completion Date :
For enrollment please visit www.clinicaltrials.gov.