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

NCT00511095 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2019-04-30

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

HEPLISAV

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

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Eduardo Martins, MD, DPhil · Dynavax Technologies Corporation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-10-31
Completion
2008-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00511095 on ClinicalTrials.gov