Clinical Trials Logo

Clinical Trial Summary

The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.


Clinical Trial Description

The purpose of this study is to determine if ShigActive is safe and effective in healthy adults in a continuous Phase 1/2a trial. Phase 1 will asses the safety of ShigActive in healthy adults, while Phase 2a will evaluate the safety and efficacy of ShigActive in healthy adults after a challenge with Shigella. ShigActive is a collection of bacteriophages. Bacteriophages (or phages) are viruses that infect only bacteria. The phages in ShigActive infect a specific type of bacteria called Shigella, which is the causative agent of shigellosis or dysentery. ShigActive is intended to significantly reduce or eliminate Shigella levels in the human gastrointestinal tract, which in turn, is anticipated to reduce the incidence and/or severity of shigellosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05182749
Study type Interventional
Source Intralytix, Inc.
Contact Karen Kotloff, MD
Phone 410-706-5328
Email kkotloff@som.umaryland.edu
Status Recruiting
Phase Phase 1/Phase 2
Start date February 23, 2023
Completion date June 30, 2025

See also
  Status Clinical Trial Phase
Completed NCT02797236 - SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers Phase 1
Completed NCT04056117 - A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants Phase 1/Phase 2
Not yet recruiting NCT05959616 - Shigella Sonnei 53G Human Infection Study in Kenyan Adults Phase 1
Completed NCT02445963 - Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR) Phase 1
Not yet recruiting NCT05961059 - InvaplexAR-Detox and dmLT Adjuvant in the Netherlands and Zambia Phase 1
Completed NCT00485134 - Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection Phase 1/Phase 2
Completed NCT01369927 - Shigella Sonnel O-SPC/rBRU Conjugate Vaccine Phase 1
Completed NCT02034500 - Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults Phase 1
Completed NCT01509846 - Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults Phase 1
Completed NCT02105714 - Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders N/A
Withdrawn NCT01399424 - Shigella Sonnei OSPC-rDT Conjugate Vaccine Phase 1
Completed NCT00800930 - Therapeutic Induction of Endogenous Antibiotics Phase 2
Completed NCT00368316 - Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel Phase 3
Completed NCT02388009 - Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a Phase 1
Completed NCT02017899 - A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults. Phase 1
Completed NCT01069471 - Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella Phase 1
Completed NCT02646371 - Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a Phase 2
Recruiting NCT05156528 - Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years Phase 3
Completed NCT03854929 - Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery Phase 4
Recruiting NCT05121974 - Tebipenem Trial in Children With Shigellosis Phase 2