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Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients

NCT00985426 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 521

Last updated 2021-05-19

Study results available
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Summary

The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.

Conditions

Interventions

BIOLOGICAL

HEPLISAV-B

Intramuscular (IM) injections of HEPLISAV-B at Weeks 0, 4, and 24

BIOLOGICAL

Engerix-B

Intramuscular (IM) injections at Weeks 0, 4, 8, and 24

OTHER

Placebo

Placebo(saline) intramuscular (IM) injection at Week 8

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    lead INDUSTRY

Principal Investigators

  • Robert Janssen, MD · Dynavax Technologies Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-01-31
Completion
2012-01-31

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 NCT00985426 on ClinicalTrials.gov