Clinical trials: Dysentery, Bacillary
Diarrhoea
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants.
- Trial name
- NCT06663436
- Testing
- altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain…
- Trial name
- S4V03 (NCT06615375)
- Testing
- Shigella4V2
- Where
- 3 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigellosis
Tebipenem Trial in Children With Shigellosis
Background (brief): Shigellosis is the second leading cause of death due to diarrheal diseases worldwide (>200,000 deaths/year).
- Trial name
- NCT05121974
- Testing
- Tebipenem Pivoxil, Azithromycin, Ceftriaxon
- Where
- Bangladesh
- Volunteers
- 132 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
Immunisation, Shigella Infection
Phase 2 Shigella Vaccine and Challenge
This is a trial to evaluate the safety, reactogenicity, immunogenicity and efficacy of a 10^6 cfu dose of an oral live-attenuated S.
- Trial name
- NCT04242264
- Testing
- Shigella sonnei strain 53G, WRSs2
- Where
- 2 sites in United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Shigellosis
Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old…
- Trial name
- S4V02 (NCT06523231)
- Testing
- Shigella4V2, MenACWY
- Where
- Kenya
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigella Infection
Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants
The goal of this phase 1/2a, randomized, observer-blind, age-descending, dose-finding trial is to evaluate the safety and immunogenicity of a quadrivalent synthetic oligosaccharide-based Shigella vaccine (adjuvanted IP-QSV) in…
- Trial name
- NCT07666750
- Testing
- 30μg IP-QSV, 10μg IP-QSV, 2μg IP-QSV
- Volunteers
- 370 people, healthy volunteers welcome
- Sponsor
- International Vaccine Institute
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Dysentery, Dysentery, Shigella
Clinical Trial of the S. Flexneri-S. Sonnei Bivalent Conjugate Vaccine
The goal of this clinical trial is to evaluate the protective efficacy of S. Flexneri-S. Sonnei bivalent conjugate vaccine against diarrhea caused by Shigella infection in infants and children aged 6 months to 5 years.
- Trial name
- NCT06838195
- Testing
- S. Flexneri-S. Sonnei bivalent conjugate vaccine
- Where
- Bangladesh
- Volunteers
- 8,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Diarrhea Infectious, Shigella
The Impact of Shigellosis and Recommended Treatment in Children
The purpose of this study is to evaluate whether antibiotic treatment of non-dysentery Shigella associated watery diarrhea (NDSD) cases improves clinical outcomes and growth in children.
- Conditions
- Diarrhea Infectious, Shigella, Growth & Development
- Trial name
- TrtNDSD (NCT07433426)
- Testing
- Azithromycin
- Where
- 4 sites in Bangladesh, Zambia
- Volunteers
- 700 people
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Shigella Infection, Enterotoxigenic Escherichia Coli Infection
Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122
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.
- Trial name
- NCT04634513
- Testing
- strain CVD 1208S-122
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Healthy Volunteers
ShigETEC Vaccine Study in Bangladesh
The goal of this clinical trial is to test ShigETEC vaccine, a combination vaccine against Shigella and ETEC diarrhoea in Bangladeshi adults (aged 18-45 years) and paediatric participants of three different age groups (aged 2-5…
- Trial name
- NCT05987488
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Bangladesh
- Volunteers
- 196 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Shigella, Diarrhea
First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults
Phase 1 trial to evaluate the Safety and Immunogenicity of Inventprise's (IVT) Shigella-04 in Healthy Young Adults
- Trial name
- NCT07205926
- Testing
- IVT Shigella-04
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Shigella
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.
- Trial name
- NCT07049159
- Testing
- ShigETEC vaccine, Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
Shigellosis
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
- Trial name
- NCT05182749
- Testing
- bacteriophage
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.
Shigellosis
Shigella Sonnei 53G Human Infection Study in Kenyan Adults
Diarrhoea caused by Shigella (shigellosis) is of major public health importance. However, there are no licensed Shigella vaccines in routine use, with several candidates still in various stages of clinical development.
- Trial name
- NCT05959616
- Testing
- Shigella sonnei 53G, Ciprofloxacin 500 mg
- Where
- Kenya
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Shigellosis
Controlled Human Infection Model Challenge/Rechallenge
The goal of this study is to better understand Shigella immunity. The study will compare the shigellosis rate in participants previously challenged with a different Shigella serotype to the attack rate in participants not…
- Trial name
- NCT04992520
- Testing
- Shigella sonnei 53G, Shigella flexneri 2a 2457T
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- PATH
Shigella, Child
Enterics for Global Health (EFGH)
Diarrhea remains a leading cause of death among young children, with the majority of diarrhea deaths occurring in low- and middle-income countries.
- Conditions
- Shigella, Child, Diarrhea
- Trial name
- EFGH (NCT06047821)
- Where
- 33 sites in Bangladesh, Kenya and 5 more
- Volunteers
- 9,800 people
- Sponsor
- University of Washington
Shigellosis, Bacillary Dysentery
InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia
The goal of this clinical trial is to test a new Shigella vaccine (InvaplexAR-DETOX) in combination with a new adjuvant (dmLT) in healthy participants.
- Trial name
- SUNSHINE (NCT05961059)
- Testing
- 2.5 μg InvaplexAR-Detox, 10 μg InvaplexAR-Detox, 0.1 μg of dmLT
- Where
- Netherlands
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Weight Gain, Anemia, Iron Deficiency
Egg Intervention During Pregnancy in Indonesia
The study consists of two arms: 1) intervention group using eggs as supplementary food given from 2nd trimester of pregnancy to birth, and 2) observational group of pregnant mothers.
- Conditions
- Weight Gain, Anemia, Iron Deficiency, Birth Weight, Birth Length
- Trial name
- PRECODE (NCT04694235)
- Testing
- Egg intervention
- Where
- Indonesia
- Volunteers
- 702 people, healthy volunteers welcome
- Sponsor
- SEAMEO Regional Centre for Food and Nutrition