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NCT Number: NCT00511095

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

11 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beeghley Medical Park, Boardman, Ohio, United States

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About this study

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™.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEPLISAV

Biological

Intramuscular (IM) injections 0.5mL on Day 0 and Week 4

Primary outcomes

  1. Percentage of Participants With Local and Systemic Post-injection Reaction Rates

    Time frame: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4

    Local and Systemic post-injection reactions.

Secondary outcomes

  1. Percentage 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: Weeks 4, 8, 12 and 28

    Seroprotective Immune Response

  2. Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28

    Time frame: Weeks 4, 8, 12, and 28

    Measurement of Serum GMC

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Registry information

Official study title

An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
Aug 3, 2007
Registry last updated
Apr 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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