NCT00511095

Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 11 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.

Detailed description

This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity. Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	HEPLISAV	Intramuscular (IM) injections 0.5mL on Day 0 and Week 4

Timeline

• Start date: 2007-06-01
• Primary completion: 2007-10-01
• Completion: 2008-03-01
• First posted: 2007-08-03
• Last updated: 2019-04-30
• Results posted: 2017-04-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study