Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01005407
• Other study ID #: DV2-HBV-16
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2019
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2452
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy
• Hepatitis B

Intervention

Biological:
• HEPLISAV and/or Placebo
Intramuscular (IM) injections on Week 0 and Week 4; placebo (saline) injection at Week 24
• Engerix-B
Intramuscular (IM) injections on Week 0, Week 4 and Week 24

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects Who Have a Seroprotective Immune Response	Percentage of subjects who have a seroprotective immune response (anti-HBsAg antibody= 10 milli-international unit (mIU)/mL) 8 weeks after the last active dose of HEPLISAV™ compared to 8 weeks after the last active dose of Engerix-B®	at Week 12 and at Week 32
Secondary	Percentage of Participants With Local and Systemic Reaction to Injections		within 7 days for post-injection reactions