Navy Medical Research Begins Study To Test E. Coli Vaccine
By Doris Ryan, Naval Medical Research Center Public Affairs



A laboratory technologist checks a specimen in the “stat lab” of the USNH Yokosuka Laboratory Department. Laboratory technologists conduct the tests that give healthcare providers the information they need to diagnose diseases. The hospital’s laboratory is accredited by the College of American Pathologists, the American Association of Blood Banks, and the Food and Drug Administration. Photo by Tom Watanabe

The Naval Medical Research Center (NMRC) will soon begin a study to test a new vaccine that could help eliminate diseases that cripple armies, put travelers in sick beds and cause millions of child deaths in undeveloped countries.

The Seattle-based group Program for Appropriate Technology and Health (PATH) and NMRC will collaborate to conduct laboratory toxicology testing of the vaccine to prevent diseases that cause debilitating stomach illnesses.

Testing is usually required by the U.S. Food and Drug Administration (FDA) before a vaccine is tested in humans.

“Clearly, a highly effective vaccine against enterotoxigenic E. coli (ETEC) would solve a large part of the problem of infectious diarrhea among the military, civilian travelers and children around the globe,” said Capt. Stephen Savarino, leader of the NMRC research team that invented and put into practice the new vaccine technology. “We believe this vaccine candidate has the potential to curtail the number and severity of food-borne illnesses due to ETEC. It may also decrease the risk of post-infectious irritable bowel syndrome, which afflicts one in 10 who experience travelers’ diarrhea.”

According to the NMRC research team, food borne diseases, including travelers’ diarrhea, have been a scourge of military operations throughout history. These diseases represent a very common communicable threat to United States and coalition forces deploying to Iraq and Afghanistan, with the potential to degrade force health and operational readiness.

These diseases also afflict 40 percent to 60 percent of the 64 million who travel from industrialized countries to lesser developed countries each year. According to the World Health Organization, acute gastroenteritis is also a serious child health threat in the developing world, accounting for 1.5 million deaths annually. 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.

For several years, ETEC has been the focus of research by the NMRC team. NMRC announced this past March, a research and licensing agreement with Sanofi-Pasteur to further advance preclinical development of the adhesin-based ETEC vaccine technology. If the first-in-human clinical trials show that the vaccine is safe and elicits good immune responses, it will enable further development of a multivalent adhesin-based ETEC vaccine.

“We are pleased to see the collaboration with PATH accelerate our clinical development of this vaccine. PATH is committing their expertise and resources to ensure that this study is done to the highest standard and to advance a vaccine candidate that also has the potential to reduce the burden of diarrheal disease among children in the developing world,” said Capt. Richard L. Haberberger Jr., NMRC commanding officer. “In today’s research environment, partnering with organizations like this is often needed to advance development of our products through the paces of clinical testing.”