MedTrace Logo

Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122

NCT04634513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-02-02

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine whether a live, oral, combined Shigella-ETEC vaccine candidate, known as strain CVD 1208S-122, is safe and immunogenic.

Conditions

  • Shigella Infection
  • Enterotoxigenic Escherichia Coli Infection

Interventions

BIOLOGICAL

strain CVD 1208S-122

Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli

OTHER

Placebo

Sodium bicarbonate buffer

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Wilbur Chen, MD, MS · Center for Vaccine Development and Global Health, University of Maryland School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2024-10-01
Completion
2024-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04634513 on ClinicalTrials.gov