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    NMRC Develops Vaccine to Safely Prevent Travelers’ Diarrhea



    Story by Steve Vanderwerff 

    Naval Medical Research Center

    SILVER SPRING, Md. – Naval Medical Research Center (NMRC) scientists presented their vaccine research to combat travelers’ diarrhea (TD) at the International E. coli and the Mucosal Immune System Symposium in Ghent, Belgium June 5.

    Travelers’ diarrhea is a principal cause of non-combat-related disease illness among deployed U.S. warfighters and NMRC researchers have been working to develop a vaccine designed to protect against Enterotoxigenic Escherichia coli (ETEC), a leading bacterial cause of diarrhea in developing countries, travelers and deployed troops.

    “TD is linked with increased risk of chronic gastrointestinal sequelae, such as post-infectious irritable bowel syndrome, said Lt. Cmdr. Tida Lee, Deputy Department Head, Enteric Diseases Department,Infectious Diseases Directorate. “Our work will pave the way to a multivalent product that may be used in the preventive medicines, equipment, and techniques available to a medical practitioner and be of high military value to reduce acute and chronic disabilities and cost associated infectious diarrhea among deployed warfighters.”

    During the presentation, “A Phase 1 Dose Escalating Study of a Prototype CS6 Subunit Vaccine with a Modified Heat-labile Enterotoxin from (ETEC),” the scientists discussed how their vaccine is based on the most prevalent colonization factors (CFs), which include CssBA, a recombinant derivative of the globally prevalent ETEC CF CS6.

    “Four-fifths of TD cases are attributable to bacterial enteropathogens,” Lee said. “More recently, accumulating evidence suggests that the effects of infection go beyond the acute illness and can lead to long term health issues.”

    Lee and her colleagues Lt. Cmdr. Michael Prouty and Dr. Chad Porter concluded that in the Phase 1 Clinical Trial CssBA and dmLT, a vaccine adjuvant or compound that enhances vaccine effectiveness, were safe and well-tolerated at all dose levels when injected into the muscle. This is the first administration of either CssBA or dmLT to humans via an intramuscular injections. Preliminary immunological assessments show a strong response against the antigen CssBA, as well as against the ETEC heat-labile toxin (LT).

    The Phase 1 clinical trial included 50 subjects, adults ages 18 to 45, all sexes and criteria-based healthy volunteers. The subjects were broken into five cohorts of 10 with a study design that escalated the dose of the vaccine in a series of steps to ensure it was safe. The vaccine was administered via intramuscular injection to alternating deltoid regions on days 0, 21 and 42. There were no vaccine related serious adverse effects or unanticipated events, indicated that the vaccine was well tolerated by the volunteers.

    According to Prouty, the next step is to achieve a follow up study with the National Institute of Allergy and Infectious Diseases, Division of Microbiology and Infectious Diseases.

    About Naval Medical Research Center
    NMRC's eight laboratories are engaged in a broad spectrum of activity from basic science in the laboratory to field studies at sites in austere and remote areas of the world to operational environments. In support of the Navy, Marine Corps, and joint U.S. warfighters, researchers study infectious diseases, biological warfare detection and defense, combat casualty care, environmental health concerns, aerospace and undersea medicine, medical modeling, simulation and operational mission support, and epidemiology and behavioral sciences.



    Date Taken: 06.24.2019
    Date Posted: 06.24.2019 12:55
    Story ID: 328904
    Location: US

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