BERKELEY, Calif. — Dynavax Technologies Corp. will start a 2,000-patient trial of its investigational adult hepatitis B vaccine, aiming for data in the first half of 2011, the San Francisco Business Times reported Feb. 8.
The Berkeley company, which has a Phase III trial under way in chronic kidney disease patients using the same vaccine, will enroll patients in Canada and the United States for this latest trial of Heplisav.
Some 1,600 of those patients will receive the vaccine while others will receive Engerix-B, a vaccine marketed by GlaxoSmithKline.
The trial will attempt to show that Heplisav is just as good as Engerix-B eight weeks after the last active dose.
The trial also is designed to show lot-to-lot consistency for immune response four weeks after the last dosing among three lots of Heplisav consecutively manufactured at Dynavax’s facility in Dusseldorf, Germany.
Current hepatitis B vaccines require three doses over six months for full effect, according to Dynavax. But because patient compliance is low, new vaccines are aiming at increased protection in a shorter time frame, the company said.