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news.Austrian biotechnology company Intercell has retained Inclinix, a US-based provider of clinical trial enrollment solutions, to recruit volunteers for its Phase III clinical trial of a travelers' diarrhea vaccine system.
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The travelers’ diarrhea (TD) vaccine is in the form of a skin patch – a novel method for delivering a vaccine that is especially compelling because it is needle-free. Inclinix will utilize its recruitment tactics to drive the enrollment of 1200 volunteers in the US and 600 in Western Europe beginning in April 2009.
The recruitment strategy for this study, appropriately named the ‘Trek study’, centers on reaching out to specific groups most likely to respond to free travel to Mexico or Guatemala while focusing on the social and altruistic impacts of clinical trial participation.
Based on compelling Phase II safety and efficacy data, this pivotal Phase III trial will follow approximately 1800 healthy volunteers age above 18 to Mexico and Guatemala, beginning in April 2009. Volunteers will receive two doses of the TD vaccine or a placebo, two weeks apart, with the last dose at least seven days prior to travel. Volunteers will then be surveyed via diary and visits for 17 days. The purpose of this trial is to evaluate the efficacy of the TD vaccine system.
Tobin Geatz, president and CEO of Inclinix, said: We are pleased that Intercell has chosen Inclinix as their partner for the TD study. We look forward to the opportunity to contribute to the development of this novel drug that has potential to make a truly global impact on the medical community.