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Intercell’s vaccine against Travelers’ Diarrhea (TD) is easily administrated by a novel needle-free vaccine patch. The vaccine candidate has entered Phase III clinical development. The trial will be conducted in the European Union and will include 1,800 subjects travelling from Europe to Mexico and Guatemala. If approved, it will be the first vaccine delivered with a patch and to prevent Travelers’ Diarrhea.

Intercell’s late-stage TD vaccine is based on a needle-free vaccine patch technology and is designed to confer protection against the most prevalent causative agents of diarrheal diseases. The vaccine will initially be used in travelers and military personnel. In addition, children in the developing world are also a critical target for such a vaccine, as diarrhea linked to enterotoxigenic E. coli (ETEC) – the most common causes of TD -- is a major health problem.

Analysis of a Phase II field study of 170 travelers verified that the vaccine patch reduced the risk of moderate to severe TD by 75 percent. The positive results from the field study were published in "The Lancet" in June 2008. In addition, clinical testing has shown a strong immune response directed against ETEC bacteria.

In December 2009 Intercell and GSK formed a strategic alliance to accelerate
the development and commercialization of needle-free, patch-based vaccines.

About Travelers’ Diarrhea

TD is caused by consumption of contaminated food or water. The onset of TD normally occurs within the first week of travel, but may occur at any time or after returning home. An infection results in watery stools three or more times in a 24-hour period, sometimes in combination with fever, nausea, bloating and abdominal cramps. The effects may also go beyond the acute symptoms of the disease; between 10 and 30 percent of those who develop TD will suffer from irritable bowel syndrome (IBS), a chronic disorder of the intestine.

Annually, approximately 20 million out of nearly 55 million international travelers develop Travelers’ Diarrhea while visiting endemic areas, which include a majority of the developing countries in Africa, Asia and Latin America. Furthermore, diarrhea caused by ETEC sickens 210 million children each year, killing more than 350,000 annually. At especially high risk of infection are young adults and individuals with suppressed immune systems.

Current treatment and prevention

The most effective treatment of diarrhea is oral rehydration therapy (ORT), the simple replacement of fluids and salts. Travelers affected by more severe forms of TD may benefit from antibiotic therapy, which can often shorten the disease. However, the benefits of antibiotic therapy are highly dependent on the causative agents and its antibiotic sensitivity, and public health officials are wary about the overuse of antibiotics.

There is today no licensed vaccine targeting primarily TD.

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