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NOT YET RECRUITING
NCT07666750
PHASE1/PHASE2

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

Sponsor: International Vaccine Institute

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a, Randomized, Observer-blind, Age-descending, Dose Finding Study to Evaluate the Safety and Immunogenicity of Institut Pasteur Quadrivalent Shigella Vaccine (IP-QSV) for Intramuscular Administration in Healthy Adults/Adolescents, Children and Infants

Key Details

Gender

All

Age Range

6 Months - 45 Years

Study Type

INTERVENTIONAL

Enrollment

370

Start Date

2026-07

Completion Date

2028-11

Last Updated

2026-06-24

Healthy Volunteers

Yes

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.