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Phase II trial data announced on new HBV vaccine.
2004 DEC 1 - (NewsRx.com & NewsRx.net) -- Dynavax Technologies (DVAX) announced that data from a randomized, double-blind, phase II, clinical trial of the company's prophylactic hepatitis B virus (HBV) vaccine showed superior results compared to GlaxoSmithKline's Engerix-B vaccine.
Protective antibody responses were achieved faster and were maintained longer with Dynavax's HBV vaccine than with Engerix-B. Dynavax's HBV vaccine combines its proprietary immunostimulatory sequence (ISS) co-administered with HBV surface antigen (HBsAg), designed to significantly enhance the level, speed, and longevity of protection.
Results from the completed phase II clinical trial demonstrated that recipients of Dynavax's HBV-ISS vaccine more rapidly achieved seroprotection after each dose when compared to Engerix-B (79% and 100% seroprotection 1 month after 1 and 2 doses administered over 2 months, respectively, compared to 12% and 64% for the Engerix-B-treated group).
The seroprotection achieved by the HBV-ISS treated group after only 2 doses was sustained more than 1 year later. The Engerix-B treated group required 3 doses to achieve 98% seroprotection that fell to 90% 6 months later. The company believes that results from this phase II clinical trial conducted in healthy young adults, combined with anticipated interim results from its phase II/III clinical trial currently underway in Singapore in an older, more difficult-to-treat ...
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Source: HighBeam Research, Phase II trial data announced on new HBV vaccine.