Clinical trials: Shigella Infection
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
Diarrhea, Diarrhea Infectious
A Baseline Study in Support of Clinical Evaluation of an Oral Shigella Vaccine Development in Africa
This study aims to address the paucity of accurate incidence data of diarrheal diseases associated with Shigella in Zambia and Burkina Faso.
- Trial name
- ShigOraVax (NCT04312906)
- Testing
- no intervention
- Where
- 3 sites in Burkina Faso, Zambia
- Volunteers
- 1,334 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
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
Dysentery
Identification of Correlates of Protection Against Shigella and Enterotoxigenic Escherichia Coli Infections
The aim of this study is to accelerate the development of vaccine candidates against diarrheal diseases caused by Shigella and Enterotoxigenic Escherichia coli (ETEC).
- Trial name
- NCT01638039
- Testing
- Laboratory Tests
- Where
- 7 sites in Israel
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Hillel Yaffe Medical Center
Diarrhea
Shigella WRSS1 Vaccine Trial in Bangladesh
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.
- Trial name
- NCT02934178
- Testing
- Shigella sonnei Strain WRSS1 Vaccine
- Where
- Bangladesh
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- PATH
Shigellosis
Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
Shigellosis remains a serious and frequent disease throughout the world. Development of vaccines has been difficult because shigellae are habitants of and pathogens for humans only and there is no consensus about the mechanism(s)…
- Trial name
- NCT00368316
- Testing
- Shigella conjugate vaccines
- Where
- 2 sites in Israel
- Volunteers
- 2,799 people
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
Soil-transmitted Helminthiasis, Schistosomiasis
Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders
NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in…
- Conditions
- Soil-transmitted Helminthiasis, Schistosomiasis, Strongyloidiasis, Shigellosis
- Trial name
- NIDIAGDigest (NCT02105714)
- Testing
- Stool culturing for pathogenic bacteria, Kato-Katz technique, Baermann technique
- Where
- 7 sites in Côte d’Ivoire, Indonesia and 2 more
- Volunteers
- 2,800 people, healthy volunteers welcome
- Sponsor
- Swiss Tropical & Public Health Institute
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
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
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
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
Dysentery, Shigella, Shigellosis
Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
The purpose of this study is to assess the efficacy of 3 days of azithromycin (AZI) compared to 3 days of ciprofloxacin (CIP) (standard-of-care) for the treatment of children hospitalised with dysentery in Ho Chi Minh City.
- Conditions
- Dysentery, Shigella, Shigellosis, Diarrhea
- Trial name
- CIPAZ (NCT03854929)
- Testing
- Ciprofloxacin, Azithromycin
- Where
- Vietnam
- Volunteers
- 364 people
- Sponsor
- Oxford University Clinical Research Unit, Vietnam
Dysentery, Dysentery, Bacillary
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
The purpose of this study is to evaluate immunogenicity and safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.
- Trial name
- NCT04865497
- Testing
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Haemophilus b Conjugate Vaccine
- Where
- China
- Volunteers
- 1,050 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Dysentery, Dysentery, Bacillary
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
The purpose of this study is to evaluate safety of S.flexneriza-S.sonnei Bivalent Conjugate Vaccine in healthy volunteers aged above 3 Months.
- Trial name
- NCT03561181
- Testing
- S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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
Diarrhoea
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06_01TP study [NCT05073003, 212149]) and a study…
- Trial name
- H06_04TP (NCT07320716)
- Testing
- AltSonflex1-2-3, Menveo, Infanrix hexa
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Dysentery, Shigellosis
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
- Trial name
- NCT05156528
- Testing
- S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine
- Where
- 9 sites in China
- Volunteers
- 21,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd