Naval Medical Research Center Announces Industry Partnership to Advance Development

By Doris Ryan, Naval Medical Research Center Public Affairs

April 15, 2010 - SILVER SPRING, Md. (NNS) -- The Naval Medical Research Center (NMRC) recently signed a major research agreement with an industry partner to accelerate development of a promising new vaccine against enterotoxigenic E. coli (ETEC), the predominant cause of travelers' diarrhea.

Historically, diarrhea has caused substantial illness for deployed military personnel, and the disease still has the potential to negatively impact operational missions today.

"We have agreed to share Navy Medicine's depth of expertise and capabilities with Sanofi Pasteur to develop this much-needed vaccine," said Capt. Stephen Savarino, leader of the NMRC research team that invented and put into practice the new vaccine technology. "In turn, our industry partner will commit their extensive resources and technical expertise to expedite its development."

Savarino also said the vaccine could significantly impact and combat the bacteria.

"We believe this vaccine has the potential to curtail the number and severity of food borne illnesses due to ETEC, and it may also decrease the risk of post-infectious irritable bowel syndrome, which afflicts one in 10 who experience travelers' diarrhea," said Savarino.

ETEC, a bacteria which causes infectious gastroenteritis and dehydration, has been a major focus of research by the NMRC team for several years. Together with their partners at the University of Colorado (UC) Denver, they developed an innovative vaccine technology that is at the crux of the new four-year cooperative research agreement between NMRC and Sanofi Pasteur. If this pre-clinical research effort proves successful, it will serve as the basis to launch the full-scale clinical development of a multivalent adhesin-based ETEC vaccine.

"We are pleased to see this cooperative agreement finalized so that our joint research can begin," said Capt. Richard L. Haberberger, Jr., NMRC commanding officer. "In today's research environment, our successes are enhanced when we can partner, in the discovery phase, with fine academic institutions like the UC Denver."

Haberberger said that while efforts remain concentrated, it could be a long time before a vaccine is readily available.

"Likewise, the process from here to vaccine licensure is both long and challenging and is best undertaken with carefully crafted industry partnerships like this one with Sanofi Pasteur," said Haberberger.

Savarino added, however, that ramifications of a vaccine could be far-reaching.

"Clearly, a highly effective vaccine against ETEC, would solve a large part of the problem of infectious diarrhea among the military, civilian travelers and children around the globe," said Savarino.

Food borne diseases, including travelers' diarrhea, have been a scourge of military operations throughout history. Today, travelers' diarrhea represents the most common communicable disease threat to U.S. and coalition forces deploying to Iraq and Afghanistan, with the potential to degrade force health and operational readiness. The illness afflicts 40-60 percent of the 80 million who travel from industrialized countries to lesser developed countries each year.

Acute gastroenteritis is also a serious child health threat in the developing world, accounting for almost 1.6 million deaths annually, according to the World Health Organization. In each of these settings, ETEC is the most common cause of bacterial diarrhea and in severe cases can lead to dehydration and shock when not treated promptly and effectively.

The NMRC is a premier research organization and headquarters for Navy Medicine's research and development enterprise whose mission is to devise operationally relevant medical research solutions for the military.

NMRC focuses on finding solutions to both traditional battlefield medical problems, such as bleeding, traumatic brain injury, combat stress and naturally occurring infectious diseases, as well as health problems associated with non-conventional weapons.

In the area of infectious diseases, vaccine solutions are sought for infections with the greatest potential of adversely affecting military operations, including diarrheal diseases, malaria and dengue fever.

Working the research, development and acquisition process through the U.S. Army Medical Research and Material Command, the Walter Reed Army Institute of Research, NMRC and the network of overseas Army and Navy medical research laboratories, the U.S. military has a long, proud history of vaccine and drug development against tropical diseases, including now-licensed vaccines against typhoid fever, Japanese encephalitis and hepatitis A.