16 completed, 2 recruiting, 2 terminated, 1 active not recruiting. 23 Phase 2, 6 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 23 | Completed 16, Recruiting 2, Terminated 2, Active not recruiting 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 1 | 6 | Completed 4, Active not recruiting 1, Not yet recruiting 1 |
Follow Dysentery, Bacillary: new trials by email Literature Review of Dysentery, Bacillary trials Research Report on Dysentery, Bacillary
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Immunogenicity Study of IP-QSV Vaccine in Healthy Adults/Adolescents, Children and Infants 30μg IP-QSV, Placebo, 10μg IP-QSV - Shigella Infection | Phase 1 / Phase 2 | Not yet recruiting | International Vaccine Institute | 370 | 2026-07-01 | 2026-06-24 |
| The Impact of Shigellosis and Recommended Treatment in Children Azithromycin, Placebo - Diarrhea Infectious, Shigella | Phase 2 | Recruiting | Johns Hopkins Bloomberg School of Public Health | 700 | 2026-03-18 | 2026-03-30 |
| 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 ShigETEC vaccine, Placebo, Challenge: Shigella flexneri 2457T at a dose of 1.5x10^3 CFU - Shigella | Phase 2 | Recruiting | Eveliqure Biotechnologies GmbH | 72 | 2025-06-30 | 2025-07-08 |
| Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants. Shigella4V2, MenACWY - Shigellosis | Phase 2 | Completed | LimmaTech Biologics AG | 110 | 2025-04-07 | 2026-08-07 |
| A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C - Diarrhoea | Phase 2 | Completed | GlaxoSmithKline | 200 | 2024-11-13 | 2026-10-26 |
| A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine Shigella4V2, Placebo - Shigellosis | Phase 2 | Completed | LimmaTech Biologics AG | 97 | 2024-11-12 | 2026-10-01 |
| Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis bacteriophage, Placebo - Shigellosis | Phase 1 / Phase 2 | Active not recruiting | Intralytix, Inc. | 52 | 2023-02-23 | 2025-06-15 |
| Phase 2 Shigella Vaccine and Challenge Placebo, Shigella sonnei strain 53G, WRSs2 - Immunisation, Shigella Infection | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 69 | 2022-10-12 | 2026-08-10 |
| Tebipenem Trial in Children With Shigellosis Tebipenem Pivoxil, Azithromycin, Ceftriaxon - Shigellosis | Phase 2 | Completed | International Centre for Diarrhoeal Disease Research, Bangladesh | 132 | 2022-08-18 | 2026-09-01 |
| A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose - Diarrhoea | Phase 1 / Phase 2 | Completed | GlaxoSmithKline | 551 | 2021-10-06 | 2026-06-22 |
| A Study to Investigate the Safety and Immunogenicity of the SF2a-TT15 Synthetic Carbohydrate-based Conjugate Vaccine Against Shigella Flexneri 2a Injection SF2A-TT15 10 µg Adjuvanted, Injection SF2A-TT15 10 µg, Injection Adjuvanted Placebo - Healthy | Phase 2 | Completed | Institut Pasteur | 248 | 2020-10-06 | 2024-04-23 |
| Shigella CVD 30000: Study of Responses to Vaccination With Shigella Vaccine SF2a-TT15 Shigella Vaccine, Placebo, S. flexneri 2a strain 2457T Challenge Agent - Shigella | Phase 2 | Completed | University of Maryland, Baltimore | 58 | 2020-03-02 | 2024-05-20 |
| A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants Shigella 4V, MenACWY, Rabies - Shigellosis | Phase 1 / Phase 2 | Completed | LimmaTech Biologics AG | 597 | 2019-09-02 | 2026-06-23 |
| Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine, Haemophilus b Conjugate Vaccine - Dysentery, Dysentery, Bacillary | Phase 2 | Completed | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | 1050 | 2019-01-19 | 2022-01-13 |
| A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults S.sonnei vaccine, Placebo, S. sonnei 53G challenge strain - Dysentery, Bacillary | Phase 2 | Completed | GlaxoSmithKline | 71 | 2018-08-29 | 2020-07-28 |
| Safety, Immunogenicity and Efficacy Study of Inactivated Whole Cell Shigella Flexneri 2a Vaccine With and Without dmLT in Adults Shigella flexneri 2a whole cell (Sf2aWC) vaccine and double mutant E. coli heat labile toxin (dmLT), Shigella flexneri 2a whole cell (Sf2aWC) vaccine, Placebo - Shigella Sonnei Dysenteries | Phase 2 | Withdrawn | PATH | 2017-08-01 | 2017-11-20 | |
| Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a Flexyn2a, Placebo - Shigellosis | Phase 2 | Completed | LimmaTech Biologics AG | 67 | 2015-12-01 | 2021-01-27 |
| Safety and Efficacy Study of WRSS1, a Shigella Sonnei Vaccine Candidate Part 1/Arm 1 of Study: WRSS1 vaccine, Part 1/Arm 2 of Study: Placebo vaccine, Part 2/Arm 1 of Study: S. sonnei 53G - Dysentery, Shigella | Phase 1 / Phase 2 | Completed | U.S. Army Medical Research and Development Command | 30 | 2010-05-01 | 2018-11-13 |
| Safety and Efficacy Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella Infection: Phase IIa CVD 1208S, a Shigella flexneri 2a live, oral vaccine, Placebo - Shigella | Phase 2 | Terminated | University of Maryland, Baltimore | 20 | 2010-01-01 | 2021-04-29 |
| Safety and Efficacy Challenge Study of CVD 1208S, a Live, Attenuated Oral Vaccine to Prevent Shigella: Phase IIb CVD 1208S, Challenge strain of wild-type Shigella flexneri 2a - Shigella | Phase 2 | Terminated | University of Maryland, Baltimore | 20 | 2010-01-01 | 2021-04-29 |
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Bacterial Infections (23) · Bacterial Infections and Mycoses (23) · Digestive System Diseases (23) · Enterobacteriaceae Infections (23) · Gastroenteritis (23) · Gastrointestinal Diseases (23) · Gram-Negative Bacterial Infections (23) · Infections (23) · Intestinal Diseases (23) · Dysentery (19) · Pathological Conditions, Signs and Symptoms (4) · Signs and Symptoms (4) · Signs and Symptoms, Digestive (4)
Azithromycin (2) · MenACWY (2) · Tetanus Toxoid (2) · Vaccines (2) · diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (2) · Aluminum Hydroxide (1) · Boostrix (1) · Butyric Acid (1) · Ceftriaxone (1) · Hepatitis B Vaccines (1) · HibTITER protein, Haemophilus influenzae (1) · L 084 (1) · Meningococcal Vaccines (1) · Rubella Vaccine (1) · Shigella Vaccines (1)
LimmaTech Biologics AG (4) · GlaxoSmithKline (3) · University of Maryland, Baltimore (3) · Institut Pasteur (2) · International Centre for Diarrhoeal Disease Research, Bangladesh (2) · U.S. Army Medical Research and Development Command (2) · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (1) · Eveliqure Biotechnologies GmbH (1) · International Vaccine Institute (1) · Intralytix, Inc. (1) · Johns Hopkins Bloomberg School of Public Health (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · PATH (1)
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Karen L Kotloff, M.D. (2) · Kawsar R Talaat, MD (2) · Alexander Sulakvelidze, PhD (1) · Armelle Phalipon, PhD (1) · Carl Mason, MD (1) · Christiane Gerke, PhD (1) · Dr David Lewis, MD (1) · Dr Odile Launay, MD (1) · Fredrick Sawe, MBChB MMED (1) · Josphat Kosgei, MD (1) · Ladaporn Bodhidatta, MD (1) · Laurence Mulard, PhD (1) · Mainga Hamaluba, MD (1)
PMID 22574737, PMID 27146000, PMID 33862589, PMID 35062694, PMID 38853614, PMID 40000088, PMID 42379208, PMID 42617627
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