Dynavax Technologies Corp. (DVAX) announced initiation of a new phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. This large safety and immunogenicity study (known as HBV-23) was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the U.S. Food and Drug Administration in February, 2013.
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.
Dynavax expects that all study subjects will be enrolled by the end of 2014 and all follow-up will be completed by the fourth quarter of 2015.
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.
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