Research Study for Healthy Adults 18 to 45 Years Old

What is the purpose of this study?

Cincinnati Children’s Hospital Medical Center is conducting a research study, sometimes known as a clinical trial or clinical study, to test how safe and effective an oral investigational vaccine is, in protecting adults against Shigella (an illness that causes diarrhea).

Who can participate?

Healthy adults 18 to 45 years old who are willing to stay in an inpatient facility for at least 10 days may be eligible to participate. 

What is involved?

This study involves initial screening visits, an inpatient stay of 10 to 13 days, up to 5 outpatient study visits, and a follow-up phone call 6 months after study completion.  A detailed list of procedures will be provided to those interested in knowing more about this study.  Here are some of the procedures:

You will:

  • Be asked about your medical history
  • Have a physical exam and your blood pressure, heart rate and temperature taken
  • Submit blood, urine and stool samples
  • Be randomized - put into one of three groups by chance - like flipping a coin, to receive one of the study vaccines or placebo (inactive pill) in a soda water drink

What are the benefits?

There is no direct benefit to you for participating in this research study.  However, your participation may help researchers learn more about the safety of this investigational vaccine.

Will I get all the facts about the study?

You will be given a consent form that thoroughly explains the details of the study. The form covers all of the procedures, the risks, the benefits, the pay, whom to contact with questions or concerns and more.  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 risks and discomforts of the study?

Some people who were given the earlier version of this vaccine had a mild to moderate headache, mild nausea, loose stools, mild fever and stomach cramps. These side effects stopped in about 24 hours and no medical treatment was needed.  A detailed list of risks and discomforts will be provided to those interested in learning more about this study.

Do participants receive pay, compensation or reimbursement?

Participants may receive up to $1,625 for their time and effort to complete the entire study.  

Who should I contact for more information?

The Gamble Program for Clinical Studies

Cincinnati Children’s Hospital Medical Center

Study Line:  513-636-7699

Principal Investigator

Robert Frenck, MD

Division of Infectious Diseases

Cincinnati Children’s Hospital Medical Center