Clinical trials: Shigella Infection
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.
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.
Healthy
A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a
A study among adults, children and infants in Kenya to determine if a new type of glycoconjugate vaccine incorporating a synthetic carbohydrate component is safe and induces immunity against Shigella.
- Trial name
- GlycoShig3 (NCT04602975)
- Testing
- Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg, Injection SF2A-TT15 2 µg Adjuvanted
- Where
- Kenya
- Volunteers
- 248 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
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.
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
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
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
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
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
Diarrhea
Invaplex 50 Vaccine Dose-Ranging
The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of…
- Trial name
- NCT00082069
- Testing
- Shigella flexneri 2a Invaplex 50
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
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
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)
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)