Reuters Health Information (2004-12-09): Dynavax hepatitis B vaccine results encouraging in trial
Drug & Device Development
Dynavax hepatitis B vaccine results encouraging in trial
Last Updated: 2004-12-09 16:06:58 -0400 (Reuters Health)
NEW YORK (Reuters) - Dynavax Technologies on Thursday said it planned to conduct a broad late-stage clinical program for its experimental hepatitis B vaccine beginning next year following encouraging interim trial results.
The company said its vaccine showed statistically significant superiority in protective antibody responses compared to a GlaxoSmithKline vaccine called Engerix-B in a traditionally more difficult to immunize older adult population.
The interim results measured the response after two doses of the Dynavax drug.
The trial of 88 healthy adults with no detectable hepatitis B virus antibodies is designed to measure response four weeks after administration of the third dose. It is expected to be completed in mid-2005, the company said.
The company previously reported that its vaccine induced more rapid immune response than the Glaxo vaccine in a small mid-stage trial of healthy younger adults.
Dynavax said it expects to begin its phase III program in multiple age groups in mid-2005.