Dynavax Technologies Corporation announced that a phase II/III clinical trial of its hepatitis B (HBV) prophylactic vaccine candidate has been initiated in Singapore.
The double-blind study will compare Dynavax's HBV vaccine candidate with GlaxoSmithKline's marketed HBV vaccine, Engerix B, the best selling hepatitis B vaccine. The trial involves 80 subjects at two study centres in Singapore and will be completed in early 2005. The subjects will all be between 40 and 70 years of age and not yet immunized against HBV. The immunization schedule consists of three injections over six months, with antibody titer levels measured four weeks after each injection. The primary endpoint of the phase II/III HBV prophylactic vaccine study will be comparative protective antibody titer levels measured after the third injection. The study will be conducted by Dr. Lim Seng Gee at the National University Hospital, and Dr. Chow Wan Cheng, at the Singapore General Hospital.
"The initiation of this phase II/III trial represents the first in a series of trials in Asia for our HBV prophylactic vaccine," said Dr Dino Dina, president and CEO of Dynavax adding "This trial is designed to show if Dynavax's vaccine can serve an unmet medical need by providing superior protection against HBV infection for a large segment of the population that responds poorly to currently marketed vaccines. The phase III trials planned for 2005 in multiple countries will expand the immunization to additional age groups, including healthy young adults and adolescents."
Dynavax Technologies Corporation is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative products to treat and prevent allergies, infectious diseases and chronic inflammatory diseases.