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
Healthy
Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain
Development of an S. sonnei human challenge model using a newly manufactured lyophilized lot of S. sonnei strain 53G (Lot 1794) that can be used in the future as a challenge strain for all S. sonnei vaccine candidates.
- Trial name
- NCT02816346
- Testing
- Shigella sonnei 53G
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PATH
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
Shigellosis, Bacillary Dysentery
Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses.
- Trial name
- NCT02445963
- Testing
- Shigella flexneri 2a InvaplexAR
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Shigellosis
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella…
- Trial name
- NCT02646371
- Testing
- Flexyn2a
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
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
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
Diarrhea
Rifaximin for Prevention of Travellers' Diarrhea
The purpose of this study is to determine if 600 mg of rifaximin, taken once a day for 14 days by healthy subjects, is safe and effective for the prevention of travellers' diarrhea compared to placebo.
- Trial name
- NCT00742469
- Testing
- Rifaximin
- Where
- Mexico
- Volunteers
- 210 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
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, 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
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 Infection
Safety and Immunogenicity of Two Live, Attenuated Oral Shigella Sonnei Vaccines: WRSs2 and WRSs3
Phase 1, randomized, double-blind, placebo controlled, dose-escalation, inpatient study of single doses of S. sonnei. Health adult subjects, ranging in age from 18 to 45 years of age (inclusive) will be screened.
- Trial name
- NCT01336699
- Testing
- WRSs2, WRSs3
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Shigella Sonnei Infection
A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine…
- Trial name
- NCT02676895
- Testing
- GVGH S. sonnei (1790GAHB) vaccine 25 μg, GVGH S. sonnei (1790GAHB) vaccine 100 μg, Menveo
- Where
- Kenya
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigellosis
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the…
- Trial name
- NCT00485134
- Testing
- 240 µg Shigella flexneri 2a Invaplex 50 vaccine, 480 µg Shigella flexneri 2a Invaplex 50 vaccine, 690 Shigella flexneri 2a Invaplex 50 vaccine
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Gastroenteritis Escherichia Coli
Phase 1 Study of dmLT ID Vaccination in Healthy Adults
This study is to determine the safety and immunogenicity of an Enterotoxigenic Escherichia coli (ETEC) candidate vaccine, attenuated recombinant Double Mutant Heat-Labile Toxin (dmLT) from ETEC, administered by the Intradermal…
- Trial name
- NCT02531685
- Testing
- Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)