NCT04312906 (ShigOraVax) is a clinical trial of no intervention in Diarrhea, sponsored by Centre for Infectious Disease Research in Zambia.

Who is sponsoring NCT04312906?

NCT04312906 is sponsored by Centre for Infectious Disease Research in Zambia.

What drugs are being tested in NCT04312906?

Interventions in NCT04312906: no intervention.

What condition does NCT04312906 study?

NCT04312906 studies Diarrhea, Diarrhea Infectious.

Is NCT04312906 still recruiting?

NCT04312906 is currently completed. Last updated 20 July 2022.

Last reviewed 2022-07-20 · How we verify

NCT04312906: ShigOraVax

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 20 July 2022

What this trial tests

trial testing no intervention in Diarrhea in 1,334 participants. Completed in 30 November 2021.

Timeline

14 September 2020

Primary endpoint
30 November 2021

30 November 2021

Quick facts

Lead sponsor	Centre for Infectious Disease Research in Zambia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,334
Start date	14 September 2020
Primary completion	30 November 2021
Estimated completion	30 November 2021
Sites	3 locations across Zambia, Burkina Faso

Drugs / interventions tested

no intervention

Conditions studied

Diarrhea — all drugs for Diarrhea →
Diarrhea Infectious — all drugs for Diarrhea Infectious →

Sponsor

Centre for Infectious Disease Research in Zambia — full company profile →

Who can join

Under 5, any sex, with Diarrhea or Diarrhea Infectious. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Incidence and antimicrobial resistance of non-typhoidal Salmonella enterica in stool samples from children under five in peri-urban Ouagadougou, Burkina Faso.
Héma A, Soulama BI, Sawadogo J, Ouédraogo AZ, et al · · 2025 · PMID 41286621 · DOI 10.1186/s12866-025-04515-1
Contribution of the Rapid LAMP-Based Diagnostic Test (RLDT) to the Evaluation of Enterotoxigenic Escherichia coli (ETEC) and Shigella in Childhood Diarrhea in the Peri-Urban Area of Ouagadougou, Burkina Faso
Héma A, Sermé S, Sawadogo J, Diarra A, et al · · 2023

Verify or expand the search:

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Currently open trials in the same condition.

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Other Centre for Infectious Disease Research in Zambia trials

Trials by the same sponsor.

NCT07107516 — Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers · Phase 1 · not yet recruiting
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NCT06503666 — Zambian Informed Motivated Aware Responsible Adolescent Girls and Adults · NA · recruiting
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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04312906 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre for Infectious Disease Research in Zambia
Last refreshed: 20 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04312906.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing