Dynavax Technologies
Corporation DVAX announced today that immunogenicity and
safety results of two Phase 3 trials (HBV-16 and HBV-17) of
HEPLISAV(TM) investigational hepatitis B vaccine were published in
the journal VACCINE accompanied by a Commentary from Drs. Stanley
Plotkin and William Schaffner. The Commentary emphasizes the effect
of 1018, the novel adjuvant contained in HEPLISAV, and concludes that
the "results from these trials add to the body of evidence that 1018
can be an important new adjuvant for immunization against hepatitis
B." These HEPLISAV data have been previously reported at medical
conferences.
The article entitled "Immunogenicity and safety of an investigational
hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant
(HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy
adults 40-70 years of age" by Dr. William Heyward and colleagues,
describes the results from a Phase 3 clinical trial of HEPLISAV
conducted in the US and Canada in over 2,400 subjects. The article
concludes that HEPLISAV induced significantly higher seroprotection
rates in all groups (including hyporesponsive populations) than the
licensed comparator hepatitis B vaccine in a shorter two-dose
schedule over one month while maintaining a similar safety profile.
The article entitled "Immunogenicity and safety of an investigational
hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant
(HBsAg-1018) compared with a licensed hepatitis B vaccine in patients
with chronic kidney disease" by Dr. Robert Janssen and colleagues,
describes the results from a Phase 3 clinical trial of HEPLISAV in
over 500 participants with CKD in the US, Canada and Germany. The
article concludes that three doses of HEPLISAV provided significantly
higher seroprotection rates and earlier and more persistent
seroprotection than the licensed comparator hepatitis B vaccine while
maintaining a similar safety profile.
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