NCT00498212

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

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

July 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

1.1 years

First QC Date

July 5, 2007

Last Update Submit

March 18, 2019

Conditions

Hepatitis B

Keywords

HeplisavHepatitis BHepatitisHBVHepatitis B vaccinekidney diseaserenal diseasekidney failurerenal failure

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 ≥ 10 mIU/ml)

    50 weeks

Study Arms (2)

1018 ISS-HBsAg-Single

EXPERIMENTAL

Single dose (3000 µg 1018 ISS + 20 µg rHBsAg)

Biological: 1018 ISS-HBsAg-Single

1018 ISS-HBsAg-Double

EXPERIMENTAL

Double dose (6000 µg 1018 ISS + 40 µg rHBsAg)

Biological: 1018 ISS-HBsAg-Double

Interventions

1018 ISS-HBsAg-SingleBIOLOGICAL

Intramuscular (IM) injection at Day 0, Week 4 and Week 24

Also known as: HEPLISAV™
1018 ISS-HBsAg-Single
1018 ISS-HBsAg-DoubleBIOLOGICAL

Intramuscular (IM) injection at Day 0, Week 4 and Week 24

Also known as: HEPLISAV™
1018 ISS-HBsAg-Double

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willing and able to give written informed consent
  • Have a glomerular filtration rate (GFR) ≤ 45 mL/min
  • Have an expectation of going on hemodialysis or are already on hemodialysis
  • Is serum negative for hepatitis B virus (HBV) antibodies, hepatitis C virus (HCV), and human immunodeficiency virus (HIV)
  • Have repeated resting blood pressure measurements ≤ 165/105 mmHg
  • Women of childbearing potential must be consistently using a highly effective method of birth control

You may not qualify if:

  • Women who are pregnant, breastfeeding or planning a pregnancy
  • Any previous HBV infection
  • Previous vaccination (1 or more doses) with any HBV vaccine
  • Any previous autoimmune diseases
  • Have a diagnosis of chronic renal failure due to autoimmune disease
  • Are at high risk for recent exposure to HBV, HCV or HIV
  • Received any antibodies within 3 months prior to study entry
  • Ever received an injection with DNA plasmids or oligonucleotides
  • Received any vaccines within 4 weeks prior to study entry
  • Received any other investigational medicinal agent within 4 weeks prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

White Hills Medical Clinic

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, B3H 1E7, Canada

Location

SMBD - Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Links

MeSH Terms

Conditions

Hepatitis BHepatitisKidney DiseasesRenal Insufficiency

Interventions

Hepatitis B Vaccines

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanLiver DiseasesDigestive System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Eduardo Martins, MD, D Phil

    Dynavax Technologies Corporation

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2007

First Posted

July 9, 2007

Study Start

July 1, 2007

Primary Completion

August 1, 2008

Study Completion

October 1, 2008

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(3)