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NCT07049159 · ClinicalTrials.gov registry record · Phase 2

Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old

A Phase 2 study of Shigella, sponsored by Eveliqure Biotechnologies.

Recruiting
Registry status
Phase 2
Development phase
72
Enrollment target
1
Study location

NCT07049159: Recruiting Phase 2 study of Shigella, sponsored by Eveliqure Biotechnologies.

NCT07049159 is a Phase 2 study of Shigella that is actively recruiting participants, run by Eveliqure Biotechnologies. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07049159, a Phase 2 study of Shigella, is actively recruiting participants, sponsored by Eveliqure Biotechnologies.

RECRUITING
Registry status
Phase 2
Development phase
72 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T. In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in a Phase 1 trial and found to be safe when given 4 times with an interval of 3 days between each dose. The efficacy of ShigETEC vaccination will be evaluated in Stage 2 of this study, when participants will be challenged with S. flexneri 2457T. The study population will be healthy adult participants in the age of 18-50 years (inclusive), which are clearly defined in the study protocol.

Primary Outcome

The proportion of participants with incidence of shigellosis caused by the challenge strain in vaccine vs. placebo recipients until the start of antibiotic administration.

Conditions Studied

Interventions

  • OTHER Placebo
  • BIOLOGICAL ShigETEC vaccine
  • BIOLOGICAL Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU

Study Locations (1)

Maryland

  • Center for Immunization Research - Baltimore

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2025-06-30
Est. Completion 2027-05-23
Phase Phase 2
Eveliqure Biotechnologies

1 total trials

What NCT07049159 shows while recruiting

NCT07049159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).

The record links to 1 condition, with Shigella appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT07049159 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT07049159 about?

NCT07049159 is a clinical study titled "Safety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old". The purpose of this study is to evaluate the efficacy of the oral, live, attenuated ShigETEC vaccine against challenge with S. flexneri 2457T. In Stage 1 of this study, ShigETEC vaccine or placebo will be administered orally to healthy participants at a dose of 5x10\^10 CFU. This dose was tested in...

What is the current status of trial NCT07049159?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2025-06-30. Estimated completion is 2027-05-23.

What conditions does trial NCT07049159 study?

This clinical trial studies the following conditions: Shigella.

What interventions are being tested in trial NCT07049159?

The interventions under investigation include: Placebo (OTHER), ShigETEC vaccine (BIOLOGICAL), Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU (BIOLOGICAL).

Who is sponsoring clinical trial NCT07049159?

This trial is sponsored by Eveliqure Biotechnologies, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07049159 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Shigella

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07049159's enrollment target sits among peer trials

72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07049159, the US trial registry maintained by the National Library of Medicine. NCT07049159 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.