Phase 2
N=207
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00511095 ↗Enrolled (actual)
207
Serious AEs
1.0%
Results posted
Apr 2017
Primary outcome: Primary: Percentage of Participants With Local and Systemic Post-injection Reaction Rates — 38.2; 37.9; 37.2; 33.0 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HEPLISAV (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Dynavax Technologies Corporation
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local and Systemic Post-injection Reaction Rates |
38.2; 37.9; 37.2; 33.0 | — |
| SECONDARY Percentage of Subjects Who Have a Seroprotective Immune Response (Anti-HBsAg ≥ 10 Milli-international Unit (mIU)/mL) at Weeks 4, 8, 12 and 28. |
32.7; 84.9; 93.4; 95.4 | — |
| SECONDARY Serum GMC of Anti-HBsAg Measured at Weeks 4, 8, 12, and 28 |
11.5; 97.1; 170.7; 349.4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00511095). 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.