Clinical Trials / Research Studies
Clinical Trials / Research Studies

Healthy Participant Study for Adults 18 to 49 Years Old

Why are we doing this research?

We want to learn more about Enterotoxigenic Escherichia coli (ETEC), a common bacterial cause of diarrhea worldwide. Knowledge from this study may be helpful in developing ETEC vaccines in the future.

Who can participate?

Adults 18 to 49 years old who are generally in good health.

Conditions

  • Healthy Adults
  • Vaccines

What will happen in the study?

This study includes approximately 10 clinic visits, an inpatient stay for up to 10 days, and 2 phone calls over a 10-month period.
Here are some of the things that will happen in this study:

You will:

  • Answer questions about your health, past or present illnesses, and medications
  • Have a physical exam which includes height, weight and vital signs
  • Provide blood, urine and stool samples
  • If eligible after screening, receive 3 study vaccine shots in the outpatient research clinic about a month apart, be admitted to the extended stay research unit up to 10 days about a month after the third study vaccine shot
  • Drink a dose of the ETEC germs about a month after the third study vaccine shot to see if the vaccinations protected you from illness. We will be sure the ETEC germs are out of your body before you go home from the extended stay research unit.

During the stay in the extended stay research unit, study staff will be available at all times to care for you.

Adults interested in participating in this study will be given a consent form that thoroughly explains all of the details of the study. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered.

What are the good things that can happen from this research?

There is no direct benefit to you for participating in this study. However, when we complete the study, we hope to know more about ETEC infections which may be helpful in developing future ETEC vaccines.

What are the bad things that can happen from this research?

Possible risks and discomforts will be discussed with those interested in learning more about the study.

Will you/your child be paid to be in this research study?

Participants may receive up to $5,021 to complete the study over 10 months.

Contact

Gamble Program for Clinical Studies
513-636-7699
gambleprogram@cchmc.org
Infectious Diseases
Cincinnati Children’s Hospital Medical Center
3333 Burnet Ave.
Cincinnati, OH 45229-3039

Study Doctor

Robert Frenck
Infectious Diseases
Cincinnati Children's Hospital Medical Center