Please note: This trial has finished recruiting and is not accepting new participants.

Research Center: University of Maryland School of Medicine
Location: 685 W. Baltimore St., Baltimore, MD 21201
Lead Researcher: Karen Kotloff, MD and Wilbur H. Chen, MD, MS
IRB Committee: This study has been reviewed and approved by the University of Maryland Institutional Review Board

Can you help us develop a vaccine that could prevent a diarrheal disease that kills 60,000 children every year worldwide? Getting a vaccine may prevent certain diseases from happening. Currently, there is no vaccine against the germ Shigella, which causes bloody diarrhea (dysentery). If researchers could develop a vaccine for this disease, society would benefit from it. It could prevent millions of disease cases and over 200,000 deaths per year worldwide.

If you are generally in good health, you may be able to help! Researchers at the University of Maryland School of Medicine are doing a preventative research study for Shigella. This study will evaluate a potential Shigella vaccine.

If you’re looking to help better the lives of people, this may be for you! Help us build a healthier world!

• Participants will help develop a potential vaccine for dysentery.
• Participants may receive a new potential vaccine for dysentery at no cost.
• Participants will be contributing valuable information that may prevent people from getting dysentery in the future.
• Participants may be compensated up to $7,300 for participating in this study. Compensation will be provided during each visit attended.
• Participants will be helping to advance medical research.

• If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
• Any information that you provide will be kept strictly confidential, except as required by law.
• Qualified health professionals will monitor your health as it relates to the study.

• Men and women aged 18-45 years old who are generally healthy
• Must be comfortable with providing blood samples
• Must not have gastrointestinal illnesses (including dyspepsia), reactive arthritis, schizophrenia, seizure disorder, or immunosuppression
• Must not be working in the food handling industry, live with or care for a child younger than 5 years old, or immunocompromised
• Must not have had a history of Enterotoxigenic Escherichia coli (ETEC) or Shigella infection within the past 5 years
• Must not have received ETEC or shigella vaccine within the past 5 years
• Must be able to attend approximately 9 study visits and a 12-day inpatient stay at the research site over approximately 8 months

The study team can explain the research in its entirety but some details are:

• This research study is funded by the Bill & Melinda Gates Foundation
• If a participant is selected to be in the inpatient part of the study, they will be admitted to an inpatient unit for a stay of about 12 days. 
  • During the inpatient stay, they will get the Shigella infection (challenge) and their illness will be managed by the research staff. 
  • If they get Shigella, they can expect to have diarrhea, blood in stools, fevers, body aches, and abdominal pain. The inpatient stay requires that the participant stays in the inpatient unit and they will not be allowed to walk off the inpatient unit, both for their protection and for the protection of the community. 

University of Maryland School of Medicine Center for Vaccine Development and Global Health

For over 40 years, our researchers in the Center for Vaccine Development and Global Health (CVD) at the University of Maryland School of Medicine (UMSOM) in Baltimore, MD have worked domestically and internationally to develop, test, and deploy vaccines to aid the world’s underserved populations.

The CVD is an academic enterprise engaged in the full range of infectious disease intervention from basic laboratory research through vaccine development, pre-clinical and clinical evaluation, large-scale pre-licensure field studies, and post-licensure assessments.

Please note:
Due to the COVID-19 pandemic, the researchers would like to assure the participants that ensuring their and the study staff’s safety is of utmost importance.