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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunogenicity and Clinical Acceptability of a Single Dose of Live Oral Cholera Vaccine Candidate in Adults 46-64 Years of Age.
What is Cholera?
- Cholera is an acute diarrheal illness caused by ingesting the bacterium, Vibrio cholerae, which can be present in contaminated food and water.
- There are an estimated 3-5 million cases and 100,000 deaths annually worldwide.
- Although severe cholera occurs, most cases are asymptomatic or mild.
- Cholera is a disease of poverty. It is most common in developing countries where access to proper water sanitation is limited.
- The most common symptoms of cholera are diarrhea, vomiting, and dehydration.
How Can I Get Cholera?
- People get cholera by ingesting food or water contaminated with the bacteria. It is not transmitted person to person.
- Though cholera is not common in the United States, travelers to endemic areas, such as parts of Africa, Asia, and Latin America, can be at risk by drinking the local water.
- Outbreaks have been particularly severe after recent natural disasters in Haiti and South Asia.
How is Cholera Treated?
- Proper water sanitation is the best way to prevent the spread of cholera.
- Safe and effective treatment exists
- Up to 80% of cholera cases can be treated with oral rehydration.
- More severe cases require intravenous fluid replacement and antibiotics.
- If left untreated, severe cholera can cause death, mostly due to dehydration.
What is the Vaccine Testing Center and the Vermont Community doing to help?
- There is currently no vaccine available for individuals from the United States traveling to areas where cholera is present and there is no single dose cholera vaccine available for use in epidemics in endemic areas.
- The University of Vermont Vaccine Testing Center (UVM VTC) is conducting a clinical trial of a single-dose, oral vaccine against cholera. This vaccine will be first licensed in the United States for use by travelers and subsequently licensed for local use in cholera-endemic countries and for outbreaks.
- Study participants are healthy adults, ages 46-64.
- The study is currently taking place over a 6-month period and involves only a few outpatient visits.
- Compensation for participation in this study is up to $275.
FAQs About the UVM VTC Cholera Vaccine Study
Has This Type of Study Been Done Before?
- The study has been designed for maximum volunteer safety and has been approved by the U.S. Food and Drug Administration (FDA), the UVM Institutional Review Board (IRB) and the UVM Biosafety Committee (IBC).
- Cholera vaccine trials similar to this one have been successfully performed at Johns Hopkins University, The University of Maryland, and Cincinnati Children’s Hospital Medical Center.
World Health Organization: http://www.who.int/mediacentre/factsheets/fs107/en/
Centers for Disease Control and Prevention: http://www.cdc.gov/cholera/general
Last modified June 10 2016 08:40 AM