CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 207 enrolled
Drug / intervention
HEPLISAVbiological
Likely dose
HEPLISAV 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00511095
NCT00511095Phase 2Completed
CompareCT.gov

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

Dynavax Technologies Corporation·interventional·Posted Aug 3, 2007·Updated Apr 30, 2019

In Brief

A Phase 2 clinical trial evaluating HEPLISAV for Hepatitis B. Completed, enrolled 207 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 3, 2007
Enrollment StartJun 1, 2007
Primary CompletionOct 1, 2007
Study CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.9 years ago

Interventions

HEPLISAVbiological

Intramuscular (IM) injections 0.5mL on Day 0 and Week 4