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Clinical Trials associated with Recombinant hepatitis B vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)Efficacy of Intradermal Hepatitis B Vaccine in Renal Failure Patients
Hepatitis B virus infection remains an important clinical issue among patients on renal replacement therapy. Seroconversion rate as defined by an anti-HBs Ab titer > 10 IU/L after intramuscular hepatitis B vaccination (HBVv) remains poor in this cohort. Factors associated with inadequate anti-HBs response include older age, diabetes mellitus, obesity and low hepatitis B vaccine dose. Various small-scale studies including multiple high dose intramuscular vaccination or multiple small dose intradermal vaccination were attempted with variable response. Recent study on dose sparing seasonal influenza vaccine delivered via a novel intradermal microneedle has demonstrated good immunogenic responses similar to full-dose intramuscular vaccination. Imiquimod, a synthetic TLR7 agonist useful for the treatment of DNA virus infection, has been shown to improve vaccine immunogenicity. The investigators therefore propose a prospective, randomized study to compare the safety and immunogenicity of intradermal hepatitis B vaccination with this novel device with intramuscular in patients on renal replacement therapy.
/ Not yet recruitingPhase 3 Estudio con pacientes en prediálisis y diálisis renal para evaluar la seguridad, tolerabilidad e inmunogenicidad de la vacuna recombinante contra la hepatitis B fabricada mediante un proceso modificado A Study in Renal Predialysis and Dialysis Patients of the Safety,Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured with a Modified Process - Estudio en diálisis de la vacuna de la Hepatitis B (recombinante)
Start Date12 Mar 2007 |
Sponsor / Collaborator- |
100 Clinical Results associated with Recombinant hepatitis B vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)
100 Translational Medicine associated with Recombinant hepatitis B vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)
100 Patents (Medical) associated with Recombinant hepatitis B vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)
100 Deals associated with Recombinant hepatitis B vaccine(Dalian Hissen Bio-Pharmaceutical Co Ltd)