Phase 3
N=2,428
Safety and Efficacy of HEPLISAV™ Hepatitis B Virus Vaccine Compared With Engerix-B® Vaccine
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00435812 ↗Enrolled (actual)
2,428
Serious AEs
1.7%
Results posted
Feb 2018
Primary outcome: Primary: Percentage of Subjects With Seroprotective Immune Response — 95.1; 81.3 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HEPLISAV and/or Placebo (Biological); Engerix-B (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Dynavax Technologies Corporation
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Seroprotective Immune Response |
95.1; 81.3 | — |
| SECONDARY Percentage of Participants With Local and Systemic Reactions to Injections |
40.4; 34.1; 35.8; 24.8; 6.5; 20.5 | — |
Summary
The purpose of this study is to find out if a new investigational hepatitis B virus vaccine, HEPLISAV™, is safe and effective compared with Engerix-B® vaccine in subjects 11-55 years old. The primary hypothesis is that the seroprotective immune response of HEPLISAV™ is at least as good as that of Engerix-B®.
Eligibility Criteria
Inclusion Criteria
- Willing and able to give written informed consent
- Is serum negative for HBV antibodies
Exclusion Criteria
- Women who are pregnant or breastfeeding
- Any previous HBV infection
- Previous vaccination with any HBV vaccine (1 or more doses)
- Any autoimmune disease
- 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 (NCT00435812). 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.