Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants

The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in adults, children, and infants in Mali. This first-in-human study is intended to obtain initial data on the safety of the adjuvanted IP-QSV vaccine and its effect on immune responses in a Shigella-endemic region.

NCT Number	NCT07666750
Lead Sponsor	International Vaccine Institute Collaborators: Institut Pasteur
Conditions	Shigella Infection
Enrollment	370 participants
Start Date	2026-07
Primary Completion	2027-08 (estimated)
Study Completion	2028-11 (estimated)
Updated on ClinicalTrials.gov	2026-06-24