Emergent BioSolutions Starts Clinical Study Of Single Dose Oral Typhoid Vaccine In Vietnam

GAITHERSBURG, Md., Nov. 21 /PRNewswire/ -- Emergent BioSolutions Inc. today 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 next generation 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 in parallel to the Phase II program to determine demographics and prevalence of the disease in the region.

The program is being undertaken in conjunction with the Hospital for Tropical Diseases in Ho Chi Minh City and Oxford University, UK, 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.”

A significant number of typhoid cases are reported in both Europe and the US, most of which are contracted while abroad. An estimated 30 million cases of typhoid and 600,000 mortalities are reported worldwide every year.

The investigational oral typhoid vaccine, if successful, would provide travelers the option of an effective, easy-to-use single dose regimen that can be taken before visiting high-risk areas. Current vaccines require either an injection or a three-to-four oral dose regimen. The company is developing this next generation typhoid vaccine using its patented Signature Tagged Mutagenesis (STM) functional genomics technology, which facilitates the development of safe, live attenuated vaccines.

The live attenuated Salmonella Typhi strain undergoing development as a typhoid vaccine is also being used by the company as an oral vaccine delivery system. Using this system, the company developed an oral vaccine against ETEC (enterotoxigenic), a common form of traveler’s diarrhea, and saw promising results in a proof-of-principle clinical study for that product. The company is also using this system to develop a therapeutic vaccine to treat chronic Hepatitis-B. The company believes that this technology could prove useful for the development of oral vaccines for the prevention or treatment of other bacterial and viral diseases, as well as allergies and cancer.

TYPHOID OVERVIEW

The Incidence -- Typhoid remains a significant health problem in many areas of the world with an estimated 30 million travelers per year from industrialized countries visiting developing countries, risking exposure to the disease. Each year, there are an estimated 30 million cases of typhoid worldwide, resulting in 600,000 deaths.

In 1994, 4.7 million travelers from the UK visited typhoid high-risk areas and the Department of Health currently recommends that travelers should be immunized if they plan to visit any country where substandard hygiene and sanitation pose a potential hazard.

Areas of highest risk are the Middle East, Africa, Mexico and Asia, especially the Indian subcontinent. In the UK, approximately 200 cases of typhoid are reported each year, of which 80% were contracted abroad.

In the US, the Centers for Disease Control and Prevention (CDC) recommend that all travelers from the United States traveling to the developing world should consider vaccination, especially travelers to Asia, Africa and Latin America. Approximately 400 cases of typhoid are reported annually in the US, of which an estimated 70% were contracted abroad.

The Risk -- The number of travelers from the developed world visiting exotic international locations continues to increase every year. These travelers risk contracting a range of infectious and potentially debilitating, or even fatal diseases unknown or uncommon in their home countries. Once infected, they may import the disease on their return, placing not just the traveler at risk, but also those with whom they come into contact. Therefore, the need remains strong for new and improved vaccines to provide effective protection against a wide-range of infectious diseases.

The Disease -- Typhoid, also known as typhoid fever, is caused by infection from the bacterium Salmonella Typhi and is usually contracted by consuming contaminated food and water-based drinks. This contamination is usually the result of poor hygiene and sanitation.

The Vaccine -- Emergent BioSolutions is developing a novel oral typhoid vaccine that will give travelers the option of an effective, easy-to-use single dose regimen that can be taken before travel to high-risk areas. Current vaccines require either an injection or a three-to-four dose regimen for the oral vaccine.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is dedicated to the research, development and manufacture of novel products that harness the immune system to treat and prevent disease. These include products for prophylactic and therapeutic use against common infectious diseases and biological weapons of mass destruction. The company currently employs more than 400 people with facilities in Gaithersburg and Frederick, Maryland; Lansing, Michigan, Berkshire, UK and Munich, Germany. More information about Emergent BioSolutions Inc., and its subsidiaries can be found at http://www.ebsi.com

Emergent BioSolutions Inc.

CONTACT: Kim Brennen Root of Emergent BioSolutions Inc., +1-517-327-1543

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