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UVM Center Demonstrates Global Health Commitment with Launch of Oral Cholera Vaccine Study

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Absent for more than 100 years in the U.S., cholera continues to challenge public health officials worldwide. The infection occurs in areas with poor sanitation, poverty, and limited access to safe drinking water. Cholera causes an estimated three to five million cases and a reported 100,000 to 120,000 deaths annually, according to the World Health Organization (WHO). The University of Vermont Vaccine Testing Center aims to help combat this worldwide threat by launching a new clinical trial to test an oral cholera vaccine, and hopes Vermonters will engage in the effort to control this global disease of poverty.

UVM cholera vaccine study co-leaders Caroline Lyon, M.D., M.P.H., assistant professor of medicine, and Beth Kirkpatrick, M.D., professor of medicine, note that the need for a single-oral dose vaccine is critical to addressing the impact of an increased number of cholera outbreaks worldwide since 2005. “Outbreaks occurring after recent natural disasters in Haiti and South Asia have put cholera vaccines back on the WHO/Centers for Disease Control radar,” says Lyon.

WHO describes cholera as an acute intestinal infection caused by ingestion of water or food contaminated with the bacterium Vibrio cholerae. Individuals affected by the bacteria can experience symptoms, including painless watery diarrhea in less than a day to five days following initial exposure. Both indigenous populations and travelers to endemic areas are at risk of contracting the disease. People without access to health care and rehydration are at risk of severe dehydration if not treated promptly.

Despite Vermont’s seemingly odd location for cholera vaccine research, UVM’s involvement in the trial is not a fluke. “UVM is one of only four or five U.S. sites with experience doing this type of vaccine-challenge study,” says Kirkpatrick, “which is why we were approached to participate.” Kirkpatrick directs the UVM Vaccine Testing Center, which has run numerous vaccine trials focused on such global health threats as dengue, typhoid fever, and campylobacter, since 2002.

The study is a Phase 3 placebo-controlled clinical trial sponsored by PaxVax, a company dedicated to the development of socially responsible vaccines (http://www.paxvax.com). The study team will follow a rigid protocol to ensure subject safety. The team expects to screen about 150 people in order to enroll 50 participants, half of whom will receive the vaccine and half of whom will receive placebo. At 10 or 90 days following vaccination, participants will be admitted and isolated in a dedicated inpatient Clinical Research Center (CRC) and receive a dose of the cholera bacteria to determine the ability of the vaccine to prevent illness.  Subjects in all groups will be followed closely by trained study physicians, nurses, and staff, for up to 12 days before being discharged from the unit.  Subjects will leave the CRC once symptoms have resolved, they have completed antibiotics and they are completely clear of infection. Two other sites, the University of Maryland and the Cincinnati Children’s Hospital Medical Center, are also participating in the trial.

Volunteers interested in obtaining more information about the study can contact the UVM Vaccine Testing Center recruiting team at 802-656-0013, online or via email.