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Virus Vaccine

HEPLISAV-B® for End Stage Renal Disease

Phase 1
Waitlist Available
Research Sponsored by Dynavax Technologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 4, 8, 16, 20
Awards & highlights

Study Summary

This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis.

Eligible Conditions
  • End Stage Renal Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 4, 8, 16, 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4, 8, 16, 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of seroprotection rate (SPR)
Safety evaluation of clinically significant adverse events
Secondary outcome measures
Evaluation of immunogenicity

Trial Design

1Treatment groups
Experimental Treatment
Group I: HEPLISAV-B®Experimental Treatment1 Intervention
A single dose of 0.5 mL HEPLISAV-B® administered intramuscularly in the deltoid muscle at Week 0 (Visit 1), Week 4 (Visit 2), Week 8 (Visit 3), and Week 16 (Visit 4).

Find a Location

Who is running the clinical trial?

Dynavax Technologies CorporationLead Sponsor
28 Previous Clinical Trials
17,261 Total Patients Enrolled
Randall N Hyer, MD, PhD, MPHStudy DirectorDynavax Technologies Corporation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis
2019. "HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03934736.
All > Dialysis
~20 spots leftby May 2025
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