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

NCT07666750 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-06-24

No results posted yet for this study

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.

Conditions

  • Shigella Infection

Interventions

BIOLOGICAL

30μg IP-QSV

A mix of the four synthetic OS-based conjugates, each independently targeting SF 2a, 3a, 6, or Sson, and using tetanus toxoid as carrier protein. 30 ㎍ of IP-QSV adjuvanted with Aluminum phosphate.

OTHER

Placebo

Sterile 0.9% sodium chloride.

BIOLOGICAL

10μg IP-QSV

A mix of the four synthetic OS-based conjugates, each independently targeting SF 2a, 3a, 6, or Sson, and using tetanus toxoid as carrier protein. 30 ㎍ of IP-QSV adjuvanted with Aluminum phosphate.

BIOLOGICAL

2μg IP-QSV

A mix of the four synthetic OS-based conjugates, each independently targeting SF 2a, 3a, 6, or Sson, and using tetanus toxoid as carrier protein. 30 ㎍ of IP-QSV adjuvanted with Aluminum phosphate.

Sponsors & Collaborators

  • Institut Pasteur

    collaborator INDUSTRY

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Samba Sow, MD · CVD-Mali

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
6 Months
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-08-31
Completion
2028-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07666750 on ClinicalTrials.gov