NCT00498212

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

A Phase 2, Single-Blind, Randomized Study of Safety and Immunogenicity Following Vaccination With Single or Double Doses of HEPLISAV™ in Adults With End-Stage Renal Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis. This study will evaluate the safety and immunogenicity of HEPLISAV™ when administered to adults who have end-stage renal disease (glomerular filtration rate \[GFR\] ≤ 45 mL/min). Once subjects have been consented, screened, and randomized to treatment, subjects will receive a total of three injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Subjects will receive 1 of the following 2 regimens: * HEPLISAV™ single dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months) * HEPLISAV™ double dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months) Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local and systemic reactogenicity. Immunogenicity will be evaluated by the proportion of subjects exhibiting a seroprotective immune response (anti-hepatitis B surface antigen antibodies \[anti-HBsAg\] ≥ 10 milli-international unit (mIU)/mL) at Weeks 4, 12, 24, 28 and 50.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	1018 ISS-HBsAg-Single	Intramuscular (IM) injection at Day 0, Week 4 and Week 24
BIOLOGICAL	1018 ISS-HBsAg-Double	Intramuscular (IM) injection at Day 0, Week 4 and Week 24

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-08-01
• Completion: 2008-10-01
• First posted: 2007-07-09
• Last updated: 2019-03-26

Locations

3 sites across 1 country: Canada