Tuesday, Dynavax Technologies Corp. (DVAX) announced that it has commenced a late-stage registration trial for hepatitis B vaccine Heplisav in individuals with chronic kidney disease.
Heplisav has been on clinical hold since last March after a single case of Wegener's granulomatosis was reported in a phase III healthy adult study conducted outside the U.S. Wegener's granulomatosis is an uncommon disease in which the blood vessels are inflamed. The vaccine is studied for both healthy adults and patients with end-stage renal disease. However, there are no clinical holds on Heplisav outside the U.S.
On August 5, the company met with the FDA to discuss its plans to resume development of Heplisav and the following month -- on September 10, the FDA lifted an 18-month clinical hold on the vaccine.
According to the company, the phase III registration trial, which has been initiated, is enrolling approximately 600 patients with chronic kidney disease. The patients will be randomized to receive either 3 doses of Heplisav (at 0, 1, and 6 months) or 8 doses of the current licensed vaccine Engerix-B (2 doses at 0, 1, 2, and 6 months). The primary endpoint is seroprotection rate at month 7.
A second phase III registration trial -- a lot-to-lot consistency trial, is expected to begin in early 2010. The company expects to complete the two registration trials within the next 24 months.
Dynavax believes that these studies, taken together, could support registration filing of Heplisav with the FDA.
According to statistics, there are about 750,000 end-stage renal disease, or ESRD, patients in the United States and the 5 major European markets and approximately 150,000 new patients annually. Approximately 35% of these immunocompromised ESRD patients do not respond to traditional vaccination and 20% require boosters.
The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations, the company said.
Dynavax plans to present clinical data from previous trials of Heplisav in chronic kidney disease patients at the 47th Annual Meeting of the Infectious Disease Society of America, or IDSA, October 29 through November 1, 2009 in Philadelphia, Pennsylvania.
DVAX, which has thus far hit a 52-week low of $0.15 and 52-week high of $3.35, closed Monday's trading session at $1.89. In pre-market trading on Tuesday, the stock is up 11% at $2.10.
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