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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00511095
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : April 12, 2017
Last Update Posted : April 12, 2017
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis B Biological: HEPLISAV Phase 2

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 occurrence 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™.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™
Study Start Date : June 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HEPLISAV
3000ug 1018 ISS + 20ug HBsAg Intramuscular (IM) injection 0.5mL
Biological: HEPLISAV
Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
Other Name: HEPLISAV™

Primary Outcome Measures :
  1. Occurrence of Adverse Events and Local and Systemic Reaction Rates [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Portion of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/ml) at Weeks 4, 8, 12 and 28. [ Time Frame: 28 weeks ]
  2. Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 [ Time Frame: 28 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00511095

United States, Ohio
Beeghley Medical Park
Boardman, Ohio, United States, 44512
United States, Pennsylvania
Family Healthcare Partners
Grove City, Pennsylvania, United States, 16127
Pediatric Alliance Southwestern
Pittsburg, Pennsylvania, United States, 15217
Primary Physicians Research
Pittsburg, Pennsylvania, United States, 15241
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
Study Director: Eduardo Martins, MD, DPhil Dynavax Technologies Corporation

Additional Information:
Responsible Party: Dynavax Technologies Corporation Identifier: NCT00511095     History of Changes
Other Study ID Numbers: DV2-HBV-14
First Posted: August 3, 2007    Key Record Dates
Results First Posted: April 12, 2017
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a BLA in progress at this time. Data to be shared post approval. CRL accepted by FDA 3/2017

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

Additional relevant MeSH terms:
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
Immunologic Factors
Physiological Effects of Drugs