by Doris Ryan
The Naval Medical Research Center (NMRC) began a preclinical study with a nonprofit partner to test a promising new vaccine candidate against travelers' diarrhea. PATH and NMRC will collaborate to conduct laboratory toxicology testing of the vaccine, which is usually required by the U.S. Food and Drug Administration (FDA) before a vaccine is tested in humans.
"We are very pleased to be teaming up with PATH to conduct this critical study, the last hurdle before initiation of the first-in-human testing of our new enterotoxigenic E. coli (ETEC) vaccine candidate," 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 ten 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. Today, travelers' diarrhea represents a very 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. It also afflicts 40 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 in March 2010 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 adhesinbased 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."
"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.
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 disease, as well as health problems associated with nonconventional weapons. In the area of infectious diseases, vaccine solutions are sought for infections with the greatest potential of adversely affecting military operations, and include diarrheal diseases, malaria, and dengue fever. Working the R&D and acquisition process through the U.S. Army Medical Research and Materiel 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.
PATH is an international nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public- and private-sector partners, PATH provides appropriate health technologies and vital strategies that change the way people think and act. PATH's work improves global health and well-being.
For more information, contact Doris Ryan, public affairs officer at the Naval Medical Research Center, 301-319-9378, or doris.ryan@med.navy.mil.
