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

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Dynavax Technologies Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Treatment Details

Interventions

• Engerix-B (Virus Vaccine)
• HEPLISAV (Virus Vaccine)

Participant Groups

Group I: HEPLISAV and/or Placebo Experimental Treatment 1 Intervention

0.5 mL HEPLISAV (20 mcg HBsAg and 3000 mcg 1018)

Group II: Engerix-B(1) Active Control 1 Intervention

1.0 mL Engerix-B

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NCT01005407 Denver, CO

NCT01005407 Melbourne, FL

NCT01005407 Pinellas Park, FL

NCT01005407 Peoria, IL

More Trial Locations

Who Is Running the Clinical Trial?

Dynavax Technologies Corporation Lead Sponsor

References