Not Yet RecruitingPhase 1/2

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

370 participantsStarted 2026-07

Plain-language summary

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.

Who can participate

Age range

6 Months – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 mont…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serious adverse events (SAEs) and adverse events of special interest (AESIs) and medically attended adverse event (MAAE)

Timeframe: through study completion, an average of 6 months

Immediate adverse events

Timeframe: Within 30 minutes post each dose

Solicited adverse events

Timeframe: Within 7 days post each dose

Unsolicited adverse events

Timeframe: Within 28 days post each dose

GMT of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks and at 6 months post primary IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-8 months

Timeframe: Baseline, at 4 weeks, and at 6 months post primary IP administration series

Seroconversion of serum IgG against SF 2a, SF3a, SF6 & Sson LPS at 4 weeks and at 6 months post primary IP administration of IP-QSV 2/10/30μg OS-equivalent dosages in infants aged 6-8 months

Timeframe: at 4 weeks and at 6 months post primary IP administration series

Trial details

NCT IDNCT07666750

SponsorInternational Vaccine Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Tarun Saluja, MD

+82 2 8811 236 tarun.saluja@ivi.int

View on ClinicalTrials.gov More Shigella Infection trials