UVM Clinical Trials Lead to First FDA Approved Cholera Vaccine in U.S.

July 22, 2016 by Jennifer Nachbur

Cholera outbreaks continue to plague areas like South Sudan, Eastern Uganda, and Kerala, India, but there’s hope for addressing this infectious disease: Last month, the Food and Drug Administration approved the only vaccine for use in the U.S. to protect against cholera infection. The University of Vermont’s Vaccine Testing Center was one of three national sites to test the vaccine – called Vaxchora – for effectiveness.

Vaccine Testing Center lab (Photo: Andy Duback)

Cholera outbreaks continue to plague areas like South Sudan, Eastern Uganda, and Kerala, India, but there’s hope for addressing this infectious disease: Last month, the Food and Drug Administration approved the only vaccine for use in the U.S. to protect against cholera infection. The University of Vermont’s Vaccine Testing Center was one of three national sites to test the vaccine – called Vaxchora – for effectiveness.

Cholera is an infectious diarrheal disease caused by the bacteria Vibrio cholerae. The infection often occurs in areas with poor sanitation and limited access to safe drinking water. These locations also lack adequate health care, so the risk of severe dehydration and even death is much higher. According to the World Health Organization (WHO), there are an estimated three to five million cases of cholera infection and 100,000 to 120,000 deaths due to the disease annually.

While cholera has been mostly absent for more than 100 years in the U.S., the vaccine will now be available for travelers, emergency aid workers, and military personnel who travel to areas where cholera is common or where there is an ongoing outbreak. Though Vaxchora will initially be available only in the U.S., it is expected to eventually be used around the globe.

UVM researchers, Caroline Lyon, M.D., MPH, associate professor of medicine, and Beth Kirkpatrick, M.D., professor of medicine, note that the need for such a vaccine has been critical to addressing the increased number of cholera outbreaks since 2005.

“Outbreaks occurring after recent natural disasters in Haiti and South Asia demonstrate why the development of a single-dose oral cholera vaccine has been so important.” says Lyon.  “We are proud that our work has led to approval of a vaccine that will impact so many people worldwide.”

The human challenge trials conducted by the Vaccine Testing Center and local volunteers helped gain FDA approval for this groundbreaking vaccine. Despite Vermont’s seemingly odd location for cholera vaccine research, UVM’s involvement is not a fluke.

“UVM’s Vaccine Testing Center is one of only four or five U.S. sites capable of doing this type of vaccine challenge study, which is why we were approached to participate,” says Kirkpatrick, director of the Vaccine Testing Center.

Two other sites, the University of Maryland and the University of Cincinnati, also participated in the trial. The Vaxchora vaccine was originally developed at the University of Maryland, and has been acquired by PaxVax, a biotechnology company dedicated to the development of socially responsible vaccines based in California.

To obtain more information about the study or to volunteer for future studies, contact the UVM Vaccine Testing Center recruiting office at 802-656-0013 or visit the Vaccine Testing Center website.


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