Dynavax Initiates Phase 3 Study of HEPLISAV-B(TM)
HBV-23 will provide greater clarity regarding the safety profile of HEPLISAV-B by significantly expanding the overall database of vaccinated subjects. The study will also assess the immunogenicity of HEPLISAV-B in subjects for whom approved hepatitis B vaccines are less effective.
HBV-23 Study Design
HBV-23 is an observer-blinded, randomized, active-controlled, trial being conducted at approximately 40 sites in the U.S. Approximately 8,250 adult subjects between the ages of 18 and 70 will be randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of a control vaccine, Engerix-B®. Enrollment will be stratified by site, age group and type 2 diabetes mellitus status. Safety follow-up will continue for all subjects through study week 56.
The co-primary objectives of HBV-23 are to:
- Evaluate the overall safety of HEPLISAV-B with respect to clinically significant adverse events (AEs), and
- Demonstrate the noninferiority of the seroprotection rate induced by HEPLISAV-B compared with Engerix-B at Week 28 in subjects with type 2 diabetes mellitus.
The study also includes multiple secondary objectives intended to further elucidate the safety profile of HEPLISAV-B with respect to specific outcomes and to assess its immunogenicity in subpopulations including smokers, men, individuals with higher body mass, and those aged 40 years and older.
All AEs from HBV-23 that are considered to represent potential autoimmune disorders will be reviewed by an independent
Additional details regarding HBV-23 are available at www.clinicaltrials.gov.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.
About
Forward-Looking Statements
This press release contains "forward-looking" statements, including expectations for the conduct, timing and sufficiency of an additional clinical trial for HEPLISAV-B. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and review and approval of HEPLISAV-B and our process for its manufacture can occur without significant delay or additional studies; whether our studies and manufacturing efforts are sufficient to support registration for commercialization of HEPLISAV-B in either or both of the US and
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