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A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine

NCT06615375 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-13

No results posted yet for this study

Summary

In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain compared to participants receiving placebo.

Conditions

  • Shigellosis

Interventions

BIOLOGICAL

Shigella4V2

Shigella4V2 is a tetravalent bioconjugate vaccine

BIOLOGICAL

Placebo

Phosphate-buffered saline

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    collaborator OTHER

  • LimmaTech Biologics AG

    lead INDUSTRY

Principal Investigators

  • Kawsar R Talaat, MD · Johns Hopkins Bloomberg School of Public Health

  • Paulina A Rebolledo, MD · Emory University

  • Robert W Frenck, Jr., MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-12
Primary Completion
2026-04-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06615375 on ClinicalTrials.gov