A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal Disease

Summary

The purpose of this study is to find out if a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, is safe and effective for end-stage renal disease (ESRD) patients. Two dose levels will be studied: a single dose and a double dose. We expect both dose levels to safely immunize patients against HBV. The study will determine which dose does this best.

Timeline

Start

2007-07

Primary completion

2008-08

Completion

2008-10

Outcome

Outcome not reported

Stopped: “Voluntary halt due to an FDA Clinical Hold issued in relation to DV2-HBV-10.”

Drugs

Indications