Dr Steven Chatfield
GAITHERSBURG, Md. —Emergent BioSolutions Inc. announced the commencement of dosing of volunteer subjects in a clinical study in Ho Chi Minh City, Vietnam, to evaluate the safety and immunogenicity of the company’s single-dose oral typhoid vaccine.
This trial is the first study in a Phase II clinical program involving adult Vietnamese volunteers in a series of age-descending trials prior to a Phase III efficacy study in children. A surveillance study will also be conducted parallel to the Phase II program to determine demographics and prevalence of the disease in the region.
The program announced Nov. 21, 2005, is being undertaken in conjunction with the Hospital for Tropical Diseases in Ho Chi Minh City and Oxford University in England with financial support from the Wellcome Trust.
“The commencement of this study represents a major step on the path to commercialization of our typhoid vaccine,” said Dr Steven Chatfield, chief scientific officer of Emergent BioSolutions. “This product program has the potential to lead to a single oral dose vaccine that is simple to administer, facilitating vaccination in all populations, including residents of areas where typhoid fever is endemic or epidemic, and tourists and business travelers as well.”
An estimated 30 million cases of typhoid and 600,000 mortalities are reported worldwide every year.
Current vaccines require either an injection or a three or four oral dose regimen.
Emergent BioSolutions Inc., formed in 2004, is dedicated to the research, development and manufacture of products that harness the immune system to treat and prevent disease. These include vaccines and related products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction.
