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.
Individuals aged 18-45 years in Group A, 2-5 years in Groups B and C, 6-8 months in Groups D, E and G , and 9-11 months in Group F
Participants/ Participants' Legally Acceptable representative (LAR) willing to provide written informed consent to participate in the study voluntarily
Participants who can comply with the study requirements
Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator
Known history or allergy to investigational vaccine components or other medications, or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial
Individuals with major congenital abnormalities, developmental disorders, genetic defects, or severe malnutrition, among other conditions which in the opinion of investigator may affect the participant's participation in the study
Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders) which in the opinion of investigator may affect the participant's participation in the study or interfere with the assessment of the study objectives
Use of systemic steroids within past 6 months (>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months
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Treatment groupsSee each treatment group below.
International Vaccine Institute
Lead sponsor
Institut Pasteur
Collaborator