Clinical trial NCT00511095: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Keywords: Hepatitis B vaccine
HBV vaccine
Hepatitis B
Hepatitis
HBV
Vaccine
1018
HBsAg
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2007-08-03
Enrollment: 207
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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™.

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

Primary outcomes:
measure: Percentage of Participants With Local and Systemic Post-injection Reaction Rates
timeFrame: Within 7 days post-injection for post-injection reactions at Week 0 and Week 4
Secondary outcomes:
measure: Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28.
timeFrame: Weeks 4, 8, 12 and 28
measure: Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28
timeFrame: Weeks 4, 8, 12, and 28
Other outcomes:
Locations:
city: Boardman
country: United States
facility: Beeghley Medical Park
state: Ohio
city: Grove City
country: United States
facility: Family Healthcare Partners
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance Southwestern
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: Family Practice Medical Associates South
state: Pennsylvania
city: Washington
country: United States
facility: The Washington Hospital Family Medicine
state: Pennsylvania
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
Study officials:
affiliation: Dynavax Technologies Corporation
name: Eduardo Martins, MD, DPhil
role: STUDY_DIRECTOR
References: