Summary:
The purpose of this research study is to test a vaccine against a germ called Shigella. The Shigella infection can cause bloody diarrhea, fevers, body aches, and abdominal pain. The Shigella infection is common in developing countries, but not common in the U.S. The study will have a duration of about 8 months. Your participation is completely voluntary. In this study you will receive 2 doses of an experimental Shigella vaccine or a placebo at outpatient clinic visits.
If you are selected to be in the inpatient part of the study, you will be admitted to an inpatient unit for a stay of about 12 days. During the inpatient stay, you will get the Shigella infection (challenge) and your illness will be managed by the research staff. If you get Shigella, you can expect to have diarrhea, blood in stools, fevers, body aches, and abdominal pain. The inpatient stay requires that you stay on the inpatient unit and you will not be allowed to walk off the inpatient unit, both for your protection and for the protection of the community. Also, you should be aware that during the inpatient stay there are rules that everyone has to follow, including no smoking and no illicit drug use. Not everyone will be in the inpatient part of the study.
You have to be healthy to participate in this study and participation is completely voluntary. As an important part of this study, we will obtain blood, urine, and stool samples from you. These samples will help us to understand more about the response to the vaccine. This study may not personally benefit you but your participation could help to develop a Shigella vaccine. There is no cost to be in this study and we will compensate you for your time in the study. There are no licensed Shigella vaccines.
Please read on to find out more information about this study.
· Be 18-45 years old and in good health
· Not be pregnant or breastfeeding
· Not have recently received a Shigella or similar vaccine or challenge.
Qualified Participants May Receive:
Your compensation will be up to $1,025 to $3,200 for completing all study-related visits. A detailed study payment schedule will be provided at the screening visit.