Intercell AG Partners With Inclinix To Enroll 1800 Volunteers For Phase III Travelers' Diarrhea Vaccine Study

Main Category: GastroIntestinal / Gastroenterology
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 20 Jan 2009 - 0:00 PDT

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Intercell AG has retained Inclinix, Inc., to recruit volunteers for their Phase III clinical trial of a Travelers' Diarrhea (TD) vaccine system. The 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.

This year, approximately 55 million international travelers will visit countries where bacteria that cause TD are endemic, particularly Africa, Asia and Latin America, and nearly 20 million of those travelers develop TD. The effects extend beyond the acute symptoms of the disease; between 10 and 30 percent of those who develop TD will develop the chronic symptoms of irritable bowel syndrome. If approved, this would be the first vaccine for TD available in the US.

Inclinix, a Wilmington, NC-based clinical trial enrollment solutions provider, will utilize its innovative recruitment tactics to drive the enrollment of 1200 volunteers in the US and 600 in Western Europe beginning in April 2009.

"We are pleased that Intercell AG has chosen Inclinix as their partner for the TD study," says J. Tobin Geatz, President and CEO, Inclinix. "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."

The recruitment strategy for this study, appropriately named the "Trek Study" (www.TrekStudy.com), 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.

In order to build awareness of the Trek Study, Inclinix has developed partnerships with major travel and tourism websites. In addition, Recruitment Monitors -- in-field enrollment experts -- will execute events in communities near investigators' sites. "Traditional media combined with a strong relevant social and mobile networking presence is a fundamental element of this enrollment campaign," explains Diane Montross, Director of Patient Recruitment for Inclinix. "We are thrilled to be using such innovative solutions to get the message out. Social communication avenues allow Inclinix to reach a unique audience. We are defining the next patient recruitment landscape."

Trek Study coordinators will be in contact with volunteers through a variety of online and print communications, building excitement and providing helpful study and travel information. The Trek Study website www.TrekStudy.com, allows interested participants to register to receive continuously updated information on topics such as travel destinations, group travel and study compensation. Volunteers will receive compensation of up to $1500 for participation, along with pre-paid mobile phones and welcome kits with useful travel tools. In a groundbreaking effort to encourage group travel, the Trek Study also features a program that provides referral compensation to refer friends.

About the Trek Study

Based on compelling Phase II safety and efficacy data, this pivotal Phase III trial will follow approximately 1800 healthy volunteers age 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.

The successful Phase II study followed 170 healthy travelers aged 18-64 to Mexico and Guatemala. The study found that of the 59 individuals who received the vaccine, only three suffered from moderate or severe diarrhea, while 23 of the 111 receiving a placebo suffered from moderate or severe diarrhea, a 75 percent reduction (p=0.007). No vaccine-related serious adverse events were reported.

About Intercell AG

Intercell AG is a growing biotechnology company which focuses on the design and development of novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical need. The Company develops antigens and adjuvants, which are derived from its proprietary technology platforms, and has in-house GMP manufacturing capabilities. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, Sanofi Pasteur, Kirin, and the Statens Serum Institut.

Intercell is listed on the Prime Market of the Vienna Stock Exchange under the symbol "ICLL"

About Inclinix

Inclinix, Inc. specializes in customized Phase I-IV clinical trial enrollment solutions that deliver productive investigator sites and qualified patients resulting in successfully completed clinical trials for the pharmaceutical, biotech and medical device industry. Clients benefit from ten years of experience in multiple therapeutic areas, as well as leading edge technologies that meet the challenge of clinical development from feasibility through compliance.

For more information please visit: http://www.intercell.com.

Inclinix, Inc.
http://www.intercell.com

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