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NCT06615375 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Shigellosis, sponsored by LimmaTech Biologics.

Recruiting
Registry status
Phase 2
Development phase
120
Enrollment target
3
Study locations

NCT06615375 is a Phase 2 study of Shigellosis that is actively recruiting participants, run by LimmaTech Biologics. The registered enrollment target is 120 participants, above the 50-participant average among 3 other Shigellosis trials with a reported enrollment target (140% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT06615375, a Phase 2 study of Shigellosis, is actively recruiting participants, sponsored by LimmaTech Biologics.

RECRUITING
Registry status
Phase 2
Development phase
120 participants
Enrollment target
3
Study locations

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 Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Shigella4V2

Study Locations (3)

Georgia

  • Hope Clinic of Emory University - Atlanta

Maryland

  • Johns Hopkins Center for Immunization Research - Baltimore

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-11-12
Est. Completion 2026-09
Phase Phase 2

Sponsor

LimmaTech Biologics

4 total trials

What the Registry Record Tells You About NCT06615375

The ClinicalTrials.gov registry entry for NCT06615375 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 50-participant average among 3 other Shigellosis trials with a reported enrollment target (140% higher). The listed sponsor is LimmaTech Biologics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Shigellosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06615375 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Georgia, Maryland, Ohio.

Frequently Asked Questions

What is clinical trial NCT06615375 about?

NCT06615375 is a clinical study titled "A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine". 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.

What is the current status of trial NCT06615375?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-11-12. Estimated completion is 2026-09.

What conditions does trial NCT06615375 study?

This clinical trial studies the following conditions: Shigellosis.

What interventions are being tested in trial NCT06615375?

The interventions under investigation include: Placebo (BIOLOGICAL), Shigella4V2 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06615375?

This trial is sponsored by LimmaTech Biologics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06615375 being conducted?

This trial has 3 study locations across Georgia, Maryland, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.