Clinical trials: Enterobacteriaceae Infections
Healthy Volunteer
Efficacy of B7A BSIgG Against E. Coli Strain B7A Challenge
Enterotoxigenic Escherichia coli (ETEC) is a major cause of diarrhea worldwide. Vaccines and therapeutics are under development to prevent ETEC disease in children and travelers.
- Trial name
- NCT03040687
- Testing
- Anti CS6 BSIgG product (Lot PD1601105CS), Anti B7A BSIgG product (Lot PD1601132ET), Bovine Immunoglobin Negative Control (Lot PD161071NC)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
Typhoid
Clinical Efficacy of Typhoid Conjugate Vaccine (Vi-TCV) Among Children Age 9 Months Through 12 Years in Blantyre, Malawi
This study will evaluate the efficacy of a Typhoid conjugate vaccine (Vi-TCV) in Malawi, Africa among children age 9 months through 12 years.
- Trial name
- NCT03299426
- Testing
- Vi-Typhoid Conjugate Vaccine (Vi-TCV), Meningococcal A Conjugate Vaccine (MCV-A)
- Where
- Malawi
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
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
Healthy Volunteers
Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)
The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.
- Trial name
- NCT06314880
- Testing
- Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
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
Salmonella Infections
A Study to Evaluate Safety, Reactogenicity, and Immune Response of GVGH iNTS-TCV Vaccine Against Invasive Nontyphoidal Salmonella Disease and Typhoid Fever in Infants
The purpose of this study is to evaluate the safety, reactogenicity, and immune response induced by the GlaxoSmithKline Biologicals SA (GSK) Vaccines Institute for Global Health (GVGH) invasive nontyphoidal Salmonella-typhoid…
- Trial name
- NCT07286370
- Testing
- Low dose of iNTS-TCV, Full dose of iNTS-TCV, TYPHIBEV
- Where
- The Gambia
- Volunteers
- 537 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
Plague
Immunogenicity and Safety of Subunit Plague Vaccine
Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis. Pneumonic plague is typically diagnosed in humans with high mortality.
- Trial name
- NCT02596308
- Testing
- Plague vaccine
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Jiangsu Province Centers for Disease Control and Prevention
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
Enterobacteriaceae Infections
Neonatal Acquisition of ESBL-PE in a Low-income Country - NeoLIC
Enterobacteriaceae, more specifically Escherichia coli and Klebsiella pneumoniae, are the bacteria most often responsible for neonatal infections in low-income countries.
- Trial name
- NeoLIC (NCT04836208)
- Where
- Madagascar
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Drug Resistance, Microbial
Quinolone Resistance Profiles and Mechanisms of Staphylococcus Aureus and Escherichia Coli From Humans, Chicken and Catfish Farms in Indonesia
The goal of this observational study is to reveal quinolone resistance profiles and mechanisms in S. aureus and E. coli in the human, animal and aquaculture sector in Blitar, Indonesia.
- Trial name
- QUINDO (NCT05652556)
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Erasmus Medical Center
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
Plague
One Year Study to Evaluate Three Different Adjuvanted Doses of the Recombinant Plague Vaccine (rF1 and rV Antigens)
One hundred and five subjects will be recruited into three groups. Each subject will receive two doses of recombinant plague vaccine at one of three dose levels (rF1 and rV recombinant antigen proteins).
- Trial name
- NCT00246467
- Testing
- Alhydrogel, rF1 and rV protein antigens
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- PharmAthene UK Limited
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
Enteric Fever, Typhoid Fever
Typhoid Conjugate Vaccine Introduction in Navi Mumbai, India
The purpose of this study is to evaluate the impact of a government-led typhoid conjugate vaccine introduction program on typhoid disease burden in Navi Mumbai, India.
- Conditions
- Enteric Fever, Typhoid Fever, Salmonella Typhi Infection
- Trial name
- NCT03554213
- Testing
- Typhoid Conjugate Vaccine
- Where
- 6 sites in India
- Volunteers
- 17,292 people, healthy volunteers welcome
- Sponsor
- Stanford University
Salmonella Infections, Salmonella Typhimurium
Challenge Non-Typhoidal Salmonella (CHANTS) Study
This protocol describes the challenge non-typhoidal Salmonella (CHANTS) study. This is a first-in-human phase 1, double-blinded, randomised, dose-escalation human infection study, conducted in healthy volunteers aged 18 to 50…
- Conditions
- Salmonella Infections, Salmonella Typhimurium, Non-typhoidal Salmonella (NTS), Invasive Non-Typhoidal Salmonella Disease
- Trial name
- CHANTS (NCT05870150)
- Testing
- Salmonella Typhimurium
- Where
- United Kingdom
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust