Clinical trials: Infectious Diarrhea
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
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
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
Escherichia Coli Infection
Safety Study of Chimeric Vaccine to Prevent ETEC Diarrhea
The purpose of the study is to determine if immunization with a chimeric E. coli protein, dsc14CfaE-sCT2/LTB5, is safe and immunogenic when administered by vaccination under the skin.
- Trial name
- NCT01644565
- Testing
- Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5, Recombinant fimbrial adhesin dscCfaE, Modified E. coli heat labile enterotoxin LTR192G
- Where
- United States
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
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
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.
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
Enterotoxigenic Escherichia Coli Infection, Diarrhea
Study Confirming A Human Challenge Model and Investigating The Safety Of VLA1701
This is a single-center, double-blind, placebo-controlled, Phase II vaccination and challenge study designed to confirm a human challenge model with E. coli strain LSN03-016011/A.
- Trial name
- NCT03576183
- Testing
- VLA1701, Challenge Strain
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Dysentery, Diarrhea
Efficacy of Rifaximin in Preventing Campylobacteriosis
This study is a randomized, double-blinded, placebo-controlled, in-patient trial evaluating the prophylactic efficacy of rifaximin against campylobacteriosis following challenge with C. jejuni.
- Conditions
- Dysentery, Diarrhea, Enteric Campylobacteriosis
- Trial name
- NCT02280044
- Testing
- Rifaximin intervention
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
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
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.
Cryptosporidium; Diarrhea, Cryptosporidiosis
Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya
The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden of waterborne diarrheal illness among infants in selected villages in Kenya.
- Conditions
- Cryptosporidium; Diarrhea, Cryptosporidiosis, Communicable Diseases, Diarrheal Disease
- Trial name
- NCT01695304
- Testing
- Ceramic water filter
- Where
- Kenya
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Antibiotic-Associated Diarrhea, Clostridium Difficile-Associated Diarrhea
Efficacy and Safety Study in the Prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridium Difficile-Associated Diarrhea (CDAD) in Hospitalized Adult Patients Exposed to Nosocomial Infection
The purpose of this study is to evaluate the efficacy and safety of Bio-K+ CL-1285 in the prevention of Antibiotic-Associated Diarrhea (AAD) and Clostridum difficile-Associated Diarrhea (CDAD) in hospitalized patients exposed to…
- Trial name
- NCT00958308
- Testing
- BIO-K+ CL-1285®
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- Bio-K Plus International Inc.
Clostridium Difficile Infection, Clostridium Difficile Diarrhea
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine.
- Trial name
- NCT00772954
- Testing
- Vaccine diluent buffer, Clostridium difficile toxoid vaccine (50 μg), Clostridium difficile toxoid vaccine (100 μg)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sanofi
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
Diarrhoea
Causes of Rotavirus Vaccine Failure in Zambian Children
Zambia recently introduced routine infant immunization against rotavirus - the most important cause of severe gastroenteritis and diarrhoea mortality in children.
- Trial name
- NCT01886833
- Where
- Zambia
- Volunteers
- 420 people, healthy volunteers welcome
- Sponsor
- Centre for Infectious Disease Research in Zambia
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)