Phase 3
N=2,452
Safety and Immunogenicity Study of the Hepatitis B Virus (HBV) Vaccine, HEPLISAV Compared to Engerix-B Vaccine
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01005407 ↗Enrolled (actual)
2,452
Serious AEs
4.1%
Results posted
Jan 2018
Primary outcome: Primary: Percentage of Subjects Who Have a Seroprotective Immune Response — 90.1; 70.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HEPLISAV and/or Placebo (Biological); Engerix-B (Biological)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Dynavax Technologies Corporation
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Have a Seroprotective Immune Response |
90.1; 70.5 | — |
| SECONDARY Percentage of Participants With Local and Systemic Reaction to Injections |
24.33; 18.87; 23.10; 16.16; 0; 13.84 | — |
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
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)
Data sourced from ClinicalTrials.gov (NCT01005407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.