Shigella WRSS1 Vaccine Trial in Bangladesh

Status Completed

Clinical Trial Summary

This is a research study of an experimental (investigational) live attenuated Shigella sonnei vaccine (WRSS1) to find a dose of the vaccine that is safe, tolerable, and develops an immune response. Shigella causes bloody and watery diarrhea, and infants and children living in developing countries experience the greatest consequences of this disease.

Clinical Trial Description

The WRSS1 vaccine in will be given to healthy toddlers (12-24 months old). The first vaccination was given to toddlers in the inpatient unit and the second and third doses will be administered on an outpatient basis. A safety evaluation was performed after the first dose before enrolling subjects in subsequent cohorts to receive a higher vaccine dose.

After the study was initiated, its funder, the Bill and Melinda Gates Foundation (BMGF) made significant changes to the PATH Enteric Vaccine Initiative (EVI) portfolio and decided not to support the three higher-dose cohorts (Cohort 1, 2, and 3) planned as part of this study. ;

Study Design

Related Conditions & MeSH terms

Diarrhea

Clinical Trial Details

NCT number	NCT02934178
Study type	Interventional
Source	PATH
Contact
Status	Completed
Phase	Phase 1
Start date	February 23, 2017
Completion date	January 10, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT06283784` - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients	N/A
Recruiting	`NCT03851835` - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis	Phase 3
Completed	`NCT04003181` - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon	N/A
Completed	`NCT03596827` - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection	N/A
Recruiting	`NCT05372068` - Cement flooRs AnD chiLd hEalth (CRADLE)	N/A
Completed	`NCT03972618` - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic	N/A
Completed	`NCT05207618` - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant	N/A
Not yet recruiting	`NCT05052489` - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed	`NCT02428647` - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation	N/A
Completed	`NCT02541695` - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Completed	`NCT01968408` - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children	Phase 3
Completed	`NCT01739231` - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults	Phase 1/Phase 2
Terminated	`NCT01048567` - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly	Phase 2
Not yet recruiting	`NCT01382199` - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients	Phase 3
Terminated	`NCT01472211` - Water-based Zinc Intervention Trial in Zinc Deficient Children	Phase 0
Completed	`NCT01371656` - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation	Phase 3
Completed	`NCT01438645` - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy	N/A
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT00760851` - Yogurt Study in Children 2-4 Years Old Attending Daycare	Phase 3