Clinical trial NCT01005407: Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Official title: An Observer-Blinded, Randomized, Parallel-Group, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Licensed Vaccine (Engerix-B®) Among Healthy Subjects 40 to 70 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: HBV vaccine
Hepatitis B vaccine
Hepatitis B
Hepatitis
HBV
Prevention & Control
Healthy
Healthy volunteers
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2009-11-01
Enrollment: 2452
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Detailed description: The purpose of the study is to evaluate the safety, immunogenicity and lot-to-lot consistency of an investigational hepatitis B virus vaccine, HEPLISAV™, in healthy adults 40 to 70 years of age

Eligibility criteria: Inclusion Criteria:

* be 40 - 70 years of age, inclusive
* be seronegative for hepatitis B surface antigen (HBsAg), antibody against hepatitis B surface antigen (anti-HBsAg), antibody against hepatitis B core antigen (anti-HBcAg), and human immunodeficiency virus (HIV)
* be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
* if female of childbearing potential, agree to consistently use a highly effective method of birth control from screening visit through the treatment phase, for up to 28 days after the last injection

Exclusion Criteria:

* if female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
* has a history of or is considered by the investigator to be at high risk for recent exposure to HBV or HIV; for example, current intravenous drug use or has unprotected sex with known HBV/HIV positive partner
* has a known history of autoimmune disease
* has previously received any hepatitis B vaccine (approved or investigational)

Primary outcomes:
measure: Percentage of Subjects Who Have a Seroprotective Immune Response
timeFrame: at Week 12 and at Week 32
Secondary outcomes:
measure: Percentage of Participants With Local and Systemic Reaction to Injections
timeFrame: within 7 days for post-injection reactions
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Melbourne
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Rockville
country: United States
state: Maryland
city: Brooklyn Center
country: United States
state: Minnesota
city: Edina
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Erie
country: United States
state: Pennsylvania
city: Grove City
country: United States
state: Pennsylvania
city: Jefferson Hills
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Upper Saint Clair
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
References:
citation: Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT. Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age. Vaccine. 2013 Nov 4;31(46):5300-5. doi: 10.1016/j.vaccine.2013.05.068. Epub 2013 May 30.