NCT00426712

Brief Summary

The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe in patients at least 40 years of age who have progressive loss of kidney function with more advanced stage 3 (GFR ≤ 45 mL/min) or stage 4 chronic kidney disease, and are expected to eventually go on hemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

January 23, 2007

Last Update Submit

March 18, 2019

Conditions

Hepatitis B

Keywords

Chronic kidney failureChronic kidney diseaseHemodialysisHBV vaccineHepatitis B vaccineHepatitis BHepatitisHBVPrevention & Control

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events and local and systemic reaction rates

    28 weeks

Secondary Outcomes (1)

  • Portion of subjects who have a seroprotective immune response (anti-HBsAg antibody ≥ 10 mIU/mL)

    28 days

Study Arms (4)

1

EXPERIMENTAL

Low dose

Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen

2

EXPERIMENTAL

Middle dose

Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen

3

EXPERIMENTAL

High dose

Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen

4

ACTIVE COMPARATOR
Biological: Hepatitis B Vaccine (Recombinant)

Interventions

1018 ISS immunostimulatory oligonucleotide with HBV surface antigenBIOLOGICAL

Intramuscular (IM) injections on Day 0, Week 4 and Week 24, plus a placebo (salt solution) injection at Week 8

Also known as: HEPLISAV™
123
Hepatitis B Vaccine (Recombinant)BIOLOGICAL

IM (in the muscle) injections on Day 0, Week 4, Week 8 and Week 24

Also known as: ENGERIX-B®
4

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to give written informed consent
  • Progressive loss of kidney function with more advanced stage 3 (GFR at least 45 mL/min) or stage 4 chronic kidney disease by National Kidney Foundation classification, and are expected to eventually go on hemodialysis
  • Body mass index of 31 or less

You may not qualify if:

  • Received previous vaccination with any HBV vaccine (1 or more doses)
  • Any history of HBV infection
  • Pregnant or breast-feeding, or planning a pregnancy during the study
  • Has autoimmune disease
  • Diagnosis of chronic kidney failure due to autoimmune disease
  • Receiving hemodialysis treatment at the time of enrollment
  • Received any blood products or antibodies within 3 months prior to study entry, or is likely to require blood products during the study
  • Ever received an injection with DNA plasmids or oligonucleotides
  • Received erythropoietin within 7 days prior to the first study injection
  • Received vaccination with any vaccines during the 4 weeks prior to study entry
  • Received any other investigational medicinal agent during the 4 weeks prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

West Coast Clinical Trials

Costa Mesa, California, 92626, United States

Location

Twin Cities Clinical Research

Brooklyn Center, Minnesota, 55430, United States

Location

Covance

Austin, Texas, 78727, United States

Location

University of Virginia Health System, Nephrology Clinical Research Center

Charlottesville, Virginia, 22908, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis BKidney Failure, ChronicRenal Insufficiency, ChronicHepatitis

Interventions

Hepatitis B VaccinesEngerix-B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanLiver DiseasesDigestive System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Eduardo Martins, MD, DPhil

    Dynavax Technologies Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 25, 2007

Study Start

January 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 20, 2019

Record last verified: 2019-03

Locations

US(4)