Clinical trials: Shigella Infection
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)
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
Diarrhea
Dose Escalating Study of Intramuscular Invaplex[AR-DETOX]
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.
- Trial name
- NCT03869333
- Testing
- Invaplex[AR-DETOX]
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- PATH
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
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
Shigella
Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine
The purpose of this study is to determine whether SF2a-TT15 (a monovalent synthetic carbohydrate-based conjugate Shigella vaccine) is safe and effective in the prevention of Shigella infection.
- Trial name
- NCT04078022
- Testing
- SF2a-TT15 Shigella Vaccine, S. flexneri 2a strain 2457T Challenge Agent
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Shigella Infection
Healthy Adult Volunteer Study for Two Doses of a Shigella Vaccine
The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
- Trial name
- NCT00210288
- Testing
- SC599
- Where
- 2 sites in France, United Kingdom
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Shigellosis
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine…
- Trial name
- NCT01069471
- Testing
- Shigella vaccine
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlycoVaxyn AG
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
Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different dosages by different routes…
- Trial name
- NCT02034500
- Testing
- S. sonnei 1790GAHB
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
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
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
Shigellosis
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
- Trial name
- NCT02388009
- Testing
- Flexyn2a, Flexyn2a plus adjuvant
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigella Sonnei Dysenteries
Safety, Immunogenicity and Efficacy Study of Inactivated Whole Cell Shigella Flexneri 2a Vaccine With and Without dmLT in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC) and an adjuvant called dmLT.
- Trial name
- NCT03038243
- Testing
- Shigella flexneri 2a whole cell (Sf2aWC) vaccine and double mutant E. coli heat labile toxin (dmLT), Shigella flexneri 2a whole cell (Sf2aWC) vaccine
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- PATH
Shigellosis
Shigella Sonnei OSPC-rDT Conjugate Vaccine
The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a saccharide-protein conjugate composed of a fragment of S. sonnei LPS.
- Trial name
- NCT01399424
- Testing
- CP
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Diarrheal Disease, Infectious, Gastrointestinal Disease
Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults
This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age.
- Conditions
- Diarrheal Disease, Infectious, Gastrointestinal Disease, Reactive Arthritis
- Trial name
- NCT05409196
- Testing
- ShigETEC live, attenuated, oral vaccine
- Where
- Hungary
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Eveliqure Biotechnologies GmbH
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, 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