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

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HEPLISAV
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Hepatitis B vaccine, HBV vaccine, Hepatitis B, Hepatitis, HBV, Vaccine, 1018, HBsAg

Eligibility Criteria

11 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beeghley Medical Park
  • Family Healthcare Partners
  • Pediatric Alliance Southwestern
  • Primary Physicians Research
  • Family Practice Medical Associates South
  • The Washington Hospital Family Medicine
  • Metropolitan Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HEPLISAV

Arm Description

0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.
Seroprotective Immune Response
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28
Measurement of Serum GMC

Full Information

First Posted
July 25, 2007
Last Updated
April 16, 2019
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00511095
Brief Title
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
Official Title
An Open-Label Study of Safety and Immunogenicity in Subjects Following Injection With Two Doses of HEPLISAV™
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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™.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Hepatitis B vaccine, HBV vaccine, Hepatitis B, Hepatitis, HBV, Vaccine, 1018, HBsAg

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HEPLISAV
Arm Type
Experimental
Arm Description
0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018) Intramuscular (IM) injection 0.5mL
Intervention Type
Biological
Intervention Name(s)
HEPLISAV
Intervention Description
Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
Primary Outcome Measure Information:
Title
Percentage of Participants With Local and Systemic Post-injection Reaction Rates
Description
Local and Systemic post-injection reactions.
Time Frame
Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.
Description
Seroprotective Immune Response
Time Frame
Weeks 4, 8, 12 and 28
Title
Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28
Description
Measurement of Serum GMC
Time Frame
Weeks 4, 8, 12, and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Martins, MD, DPhil
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Beeghley Medical Park
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Family Healthcare Partners
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
Facility Name
Pediatric Alliance Southwestern
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States
Facility Name
Primary Physicians Research
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Family Practice Medical Associates South
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
The Washington Hospital Family Medicine
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.dynavax.com
Description
Dynavax Webpage

Learn more about this trial

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

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