Clinical trials: Shigella
Immunogenicity, Shigellosis
Shigella Sonnel O-SPC/rBRU 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
- NCT01369927
- Testing
- Shigella Sonnei O-SPC/rBRU
- Where
- Israel
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
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
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
Safety and Efficacy Challenge Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella: Phase IIb
The purpose of this study is to determine whether CVD 1208S (a live, attenuated, oral vaccine) is safe and effective in the prevention of Shigella infection.
- Trial name
- NCT00866242
- Testing
- CVD 1208S, Challenge strain of wild-type Shigella flexneri 2a
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
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.
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, 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
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
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
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.
Dysentery, Bacillary
A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S.
- Trial name
- NCT03527173
- Testing
- S.sonnei vaccine, S. sonnei 53G challenge strain
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Shigella Sonnei Infection
The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study
Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported to be in the range of 5-30%, but limited number of long-term follow-up results.
- Trial name
- NCT02516683
- Testing
- Shigella sonnei infection
- Volunteers
- 229 people, healthy volunteers welcome
- Sponsor
- Yonsei University
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
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
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
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
Testing Effect of Intervention
Zinc Supplementation in Shigella Patients
Shigellosis is a major cause of morbidity and mortality in young children in Bangladesh and other developing countries. Further, the increasing emergence of resistance to a wide range of antibiotics is of great concern.
- Trial name
- NCT00321126
- Testing
- Children in the zinc group received 20 mg of elemental zinc as acetate per day in a twice-daily dose for two weeks.
- Volunteers
- 56 people
- Sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
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)
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