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Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine

This study has been completed.
Sponsor:
Information provided by:
Dynavax Technologies Corporation
ClinicalTrials.gov Identifier:
NCT00511095
First received: July 25, 2007
Last updated: June 17, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to further evaluate the safety and seroprotective immune response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects 11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dynavax Technologies Corporation:

Primary Outcome Measures:
  • Occurrence of adverse events and local and systemic reaction rates [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Portion of subjects who have a seroprotective immune response (anti-HBsAg ≥ 10 mIU/ml) at Weeks 4, 8, 12 and 28. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 1018 ISS immunostimulatory oligonucleotide with HBV surface antigen
IM (in the muscle) injections on Day 0 and Week 4
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 efficacy of two injections of HEPLISAV™ in subjects 11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been consented and screened, they will receive a total of two injections over a 28-day period, with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by ocurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic reactogenicity.

Comparison: This study does not include a control treatment; all subjects will receive treatment with HEPLISAV™.

  Eligibility

Ages Eligible for Study:   11 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing and able to give written informed consent
  • Women of childbearing potential must be willing to consistently use a highly effective method of birth control

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Any previous HBV infection
  • Previous vaccination (1 or more doses) with any HBV vaccine
  • Any previous autoimmune diseases
  • Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
  • Received any blood products or 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511095

Locations
United States, Ohio
Beeghley Medical Park
Boardman, Ohio, United States, 44512
United States, Pennsylvania
Family Healthcare Partners
Grove City, Pennsylvania, United States, 16127
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
Pediatric Alliance Southwestern
Pittsburg, Pennsylvania, United States, 15217
Family Practice Medical Associates South
Upper St. Clair, Pennsylvania, United States, 15241
The Washington Hospital Family Medicine
Washington, Pennsylvania, United States, 15301
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Dynavax Technologies Corporation
Investigators
Study Director: Eduardo Martins, MD, DPhil Dynavax Technologies Corporation
  More Information

Additional Information:
Dynavax Webpage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Eduardo Martins, MD, DPhil / Vice President, Clinical Development, Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT00511095     History of Changes
Other Study ID Numbers: DV2-HBV-14
Study First Received: July 25, 2007
Last Updated: June 17, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dynavax Technologies Corporation:
Hepatitis B vaccine
HBV vaccine
Hepatitis B
Hepatitis
HBV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 16, 2013