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

NCT00498212 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-03-26

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Eduardo Martins, MD, D Phil · Dynavax Technologies Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-08-31
Completion
2008-10-31

Countries

  • Canada

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 NCT00498212 on ClinicalTrials.gov