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A Baseline Study in Support of Clinical Evaluation of an Oral Shigella Vaccine Development in Africa

NCT04312906 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1334

Last updated 2022-07-20

No results posted yet for this study

Summary

This study aims to address the paucity of accurate incidence data of diarrheal diseases associated with Shigella in Zambia and Burkina Faso. Given the limited feasibility of the current complex diagnostic methods used to detect Shigella in endemic and developing countries due to the costs, the none availability of reagents and a requirement of expensive and complex machinery, we suggest to use a rapide, easy-to-use, cost-effective, and robust Polymerase Chain Reaction (PCR) based rapid tool, the Loop-mediated isothermal amplification (LAMP) based diagnostic assay (ES-RLDT). This baseline study will enable us to generate an accurate estimate of Shigella incidence so as to inform future trials' designs of an oral vaccine development (ShigOraVax) in Burkina Faso and Zambia.

This project is part of the EDCTP2 programme supported by the European Union under grant agreement "No RIA2018V-2308

Conditions

Interventions

OTHER

no intervention

No intervention

Sponsors & Collaborators

  • European Vaccine Initiative

    collaborator OTHER

  • Groupe de Recherche Action en Sante

    collaborator OTHER

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • Centre for Infectious Disease Research in Zambia

    lead OTHER

Principal Investigators

  • Sophie Hourard · European Vaccine Initiative

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • Burkina Faso
  • Zambia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04312906 on ClinicalTrials.gov