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Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis

End Stage Renal Disease Clinical Trial

Official title:
An Open-Label, Randomized, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis Who Have Previously Received Hepatitis B Vaccination and Are Not Seroprotected

Clinical Trial Summary

The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.

Clinical Trial Description

The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01195246
Study type Interventional
Source Dynavax Technologies Corporation
Contact
Status Completed
Phase Phase 3
Start date December 2010
Completion date August 2012
View Details
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