Shigella-04 Vaccine Study for Shigella and Diarrhea
This study is testing a new vaccine called IVT Shigella-04 to see if it is safe and if it helps your body create protection against Shigella, a bacteria that causes diarrhea. We are looking for healthy adults between 18 and 49 years old to join. The study will compare IVT Shigella-04 to a placebo (a salt water solution that has no active medicine). Researchers will be looking at how many participants have side effects (reactogenicity events and adverse events) and for how long after receiving the vaccine. The study aims to enroll 60 participants.
- Study design
- This is a Phase 1, single-site, randomized, double-blind, placebo-controlled study. About 60 healthy individuals will be enrolled.
- What's involved
- You would receive two injections 28 days apart. Researchers will monitor you for side effects for 7 days after each dose, and for up to 6 months after the second dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for reactogenicity events for 7 days after each dose, and for adverse events for up to 6 months after the second dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
At a glance
Conditions
NCT07205926
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.
Medpace Clinical Pharmacology Unit
Cincinnati, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Chief Medical Officer · STUDY_DIRECTOR · Inventprise Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Percentage of participants with reactogenicity events for 7 days after each dose7 days after Doses 1 and 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
- Percentage of participants with adverse events (AEs) from Dose 1 to 28 days after Dose 2After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
- Percentage of participants with medically attended AE's (MAAEs) from Dose 1 to 6 months after Dose 2After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
- Percentage of participants with newly diagnosed chronic medical conditions (NDCMCs) from Dose 1 to 6 months after Dose 2After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
- Percentage of participants with AEs of special interest (AESIs) from Dose 1 to 6 months after Dose 2After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04
- Percentage of participants with serious AEs (SAEs) from Dose 1 to 6 months after Dose 2After Dose 1 to 6 months after Dose 2
To assess the safety and tolerability of a 2-dose IM regimen of 5 formulations of IVT Shigella-04