InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia

The goal of this clinical trial is to test a new Shigella vaccine (InvaplexAR-DETOX) in combination with a new adjuvant (dmLT) in healthy participants. The main questions it aims to answer are: * Is the new Shigella vaccine (with and without the new adjuvant) safe and well tolerated? * How wel does the new Shigella vaccine stimulate the immune system in combination with the new adjuvant, and without the new adjuvant? Participants will receive three vaccinations at 28-day intervals. Researchers will compare the results of participants vaccinated with the vaccine in combination with the adjuvant to the results of participants vaccinated with the vaccine only and to the results of participants vaccinated with a placebo (fake vaccine).

NCT Number	NCT05961059
Lead Sponsor	Leiden University Medical Center Collaborators: Centre for Infectious Disease Research in Zambia, PATH, Walter Reed Army Institute of Research (WRAIR), Göteborg University, European Vaccine Initiative, European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions	Shigellosis, Bacillary Dysentery
Enrollment	85 participants
Start Date	2024-10-10
Primary Completion	2025-05 (estimated)
Study Completion	2025-05 (estimated)
Updated on ClinicalTrials.gov	2024-11-07