ShigETEC Vaccine Study for Shigella and ETEC Prevention
This study is testing an oral vaccine called ShigETEC to see how well it prevents infections caused by Shigella bacteria. Shigella can cause a severe form of diarrhea called shigellosis. You might be able to join if you are a healthy adult between 18 and 50 years old. Participants will either receive the ShigETEC vaccine or a placebo (an inactive substance). Later, all participants will be given a small, controlled dose of Shigella bacteria to see if the vaccine protected them. The main goal is to find out if the ShigETEC vaccine can stop shigellosis. The study aims to enroll 72 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled Phase 2b study involving 72 healthy participants. It has two stages, with participants randomly assigned to receive either the vaccine or placebo.
- What's involved
- Participants will receive four doses of the vaccine or placebo orally over 10 days. Later, they will receive one oral dose of Shigella bacteria and be closely monitored for signs of shigellosis.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 60 days after the challenge with Shigella bacteria.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old
At a glance
Conditions
NCT07049159
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Center for Immunization Research
Baltimore, Marylandno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Efficacy of the ShigETEC vaccine in preventing shigellosis caused by the challenge strainUp to study day 60
The proportion of participants with incidence of shigellosis caused by the challenge strain in vaccine vs. placebo recipients until the start of antibiotic administration.