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

This study has been terminated.
(Voluntary halt of further dosing due to an FDA Clinical Hold issued in relation to Dynavax study DV2-HBV-10)
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00498212
First received: July 5, 2007
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Biological: 1018 ISS immunostimulatory oligonucleotide with recombinant HB surface antigen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase 2, Single-Blind, Randomized Study of Safety and Immunogenicity Following Vaccination With Single or Double Doses of HEPLISAV™ in Adults With End-Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Occurrence of adverse events and local and systemic reaction rates [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Portion of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 mIU/ml) [ Time Frame: 50 weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single dose (3000 µg 1018 immunostimulatory sequence (ISS) + 20 µg rHBsAg)
Biological: 1018 ISS immunostimulatory oligonucleotide with recombinant HB surface antigen
Intramuscular (IM) injection at Day 0, Week 4 and Week 24
Other Name: HEPLISAV™
Experimental: 2
Double dose (6000 µg 1018 ISS + 40 µg rHBsAg)
Biological: 1018 ISS immunostimulatory oligonucleotide with recombinant HB surface antigen
Intramuscular (IM) injection at Day 0, Week 4 and Week 24
Other Name: HEPLISAV™

Detailed Description:

Infection with hepatitis B virus (HBV) is a major global health problem. Worldwide, it is estimated that 2 billion people have been infected previously and 350 million are chronically infected. While acute HBV infection is associated with significant illness, the risk of chronic infection is of great importance since 5-10% of infected adults will not clear the infection after the initial phase of the illness. About 25% of people who do not initially clear the infection will later develop chronic active hepatitis.

This study will evaluate the safety and immunogenicity of HEPLISAV™ when administered to adults who have end-stage renal disease (glomerular filtration rate [GFR] ≤ 45 mL/min). Once subjects have been consented, screened, and randomized to treatment, subjects will receive a total of three injections over a 24-week period, with follow-up visits at 28 and 50 weeks. Subjects will receive 1 of the following 2 regimens:

  • HEPLISAV™ single dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)
  • HEPLISAV™ double dose at Day 0, 4 weeks (1 month) and 24 weeks (6 months)

Safety and tolerability will be evaluated by occurrence of adverse events, periodic laboratory tests, vital signs, and local and systemic reactogenicity.

Immunogenicity will be evaluated by the proportion of subjects exhibiting a seroprotective immune response (anti-hepatitis B surface antigen antibodies [anti-HBsAg] ≥ 10 milli-international unit (mIU)/mL) at Weeks 4, 12, 24, 28 and 50.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498212

Locations
Canada, Newfoundland and Labrador
White Hills Medical Clinic
St Johns, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Nova Scotia
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1E7
Canada, Quebec
SMBD - Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
Study Director: Eduardo Martins, MD, D Phil Dynavax Technologies Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00498212     History of Changes
Other Study ID Numbers: DV2-HBV-11
Study First Received: July 5, 2007
Last Updated: June 16, 2014
Health Authority: Canada: Health Canada

Keywords provided by Dynavax Technologies Corporation:
Heplisav
Hepatitis B
Hepatitis
HBV
Hepatitis B vaccine
kidney disease
renal disease
kidney failure
renal failure

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Kidney Diseases
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on October 16, 2014