From: Vivian Harvey, Cemanahuac Educational Programs Coordinator

To: Potential Cemanahauc students:

We are pleased to offer people traveling to Mexico between May 2009 and June 2010 a unique opportunity. A pharmaceutical company based in Vienna, Austria with offices in Gaithersburg, Maryland, is seeking volunteers to participate in a clinical research study of an investigational patch for the prevention or lessening the symptoms of Travelers’ Diarrhea.

Cemanahuac has made arrangements so that travelers may participate in the study while in Mexico with us. Participation is entirely voluntary. It is not
necessary to be studying Spanish to participate, so a spouse could accompany the student and participate in the study, if he/she qualifies.

If you choose to participate you will be asked to sign an informed consent by the study clinician at the clinical site located nearest to where you live in the United States. Should you meet all of the study requirements, you will receive a patch to the upper arm, then, two weeks later you will return for a second patch application to your opposite upper arm. During your stay in Mexico you will complete specified study visits and procedures including a daily travel health diary. You will also need to complete a questionnaire six months post return to the U.S.

The purpose of the research study is to see if the research patch is better at
reducing the symptoms of Travelers’ Diarrhea than a patch not containing the research material, called a placebo. It is estimated that people traveling to Latin America have up to a 50 percent risk of developing diarrhea, most commonly caused by a certain bacteria. This vaccine may prevent or lessen the symptoms of Travelers’ Diarrhea. The investigational vaccine is given via a patch on the skin that is worn for approximately six hours. Two patches are applied in the three weeks prior to departure.

While the study cannot guarantee prevention of Travelers’ Diarrhea,
participants will receive the following at no charge:

Brief health checks
Clinical laboratory testing
Convenient medical monitoring by English-speaking research staff in Latin America

As part of the study, travel to Mexico will be compensated up to $1,500; either applied to travel plans/accommodations or provided to you upon completed study requirements.

The TREK research study is testing an investigational patch to determine if it prevents or lessens the symptoms of Travelers’ Diarrhea from occurring.
Travelers’ Diarrhea, often referred to as ‘Montezuma’s Revenge’, affects about 50% of people who travel throughout the developing world.
Individuals or groups may be considered for participation in this study if they meet the following criteria:

• Male or female between the ages of 18 and 64 years of age
• In general good health
• Visiting Mexico or Guatemala for at least 7 days between May 2009 and June 2010
• Willing to maintain a daily study diary for 17 days

If you would like to learn more about joining the TREK research study, please call Marsha Green: 910-332-2687 mgreen@inclinix.com

Or visit the study website at www.trekresearchstudy.com.

In all cases, please tell the person to whom you speak that you are
coming to Cemanahuac. Please write to me for more information and
clarification.

Vivian Harvey