25 completed, 3 recruiting, 1 active not recruiting, 1 not yet recruiting. 31 Phase 1, 6 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 31 | Completed 25, Recruiting 3, Active not recruiting 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 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 |
| First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Young Adults IVT Shigella-04, Placebo (0.9% saline) - Shigella, Diarrhea | Phase 1 | Recruiting | Inventprise Inc. | 60 | 2025-10-09 | 2025-11-19 |
| Shigella Sonnei 53G Human Infection Study in Kenyan Adults Shigella sonnei 53G, Ciprofloxacin 500 mg - Shigellosis | Phase 1 | Recruiting | University of Oxford | 70 | 2025-01-21 | 2025-03-13 |
| InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia 2.5 μg InvaplexAR-Detox, 10 μg InvaplexAR-Detox, 0.1 μg of dmLT - Shigellosis, Bacillary Dysentery | Phase 1 | Recruiting | Leiden University Medical Center | 85 | 2024-10-10 | 2024-11-07 |
| ShigETEC Vaccine Study in Bangladesh ShigETEC live, attenuated, oral vaccine, Placebo - Healthy Volunteers | Phase 1 | Completed | Eveliqure Biotechnologies GmbH | 196 | 2023-11-26 | 2026-01-23 |
| 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 |
| Shigella CVD 31000: Study of Responses With Shigella-ETEC Vaccine Strain CVD 1208S-122 strain CVD 1208S-122, Placebo - Shigella Infection, Enterotoxigenic Escherichia Coli Infection | Phase 1 | Completed | University of Maryland, Baltimore | 53 | 2022-09-29 | 2026-02-02 |
| Controlled Human Infection Model Challenge/Rechallenge Shigella sonnei 53G, Shigella flexneri 2a 2457T - Shigellosis | Phase 1 | Completed | PATH | 46 | 2022-04-26 | 2025-01-31 |
| 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 |
| Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults ShigETEC live, attenuated, oral vaccine, Placebo - Diarrheal Disease, Infectious, Gastrointestinal Disease | Phase 1 | Completed | Eveliqure Biotechnologies GmbH | 84 | 2020-09-16 | 2022-06-08 |
| 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 |
| Dose Escalating Study of Intramuscular Invaplex[AR-DETOX] Invaplex[AR-DETOX], Placebo - Diarrhea | Phase 1 | Completed | PATH | 58 | 2019-03-18 | 2021-07-29 |
| Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine - Dysentery, Dysentery, Bacillary | Phase 1 | Completed | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | 180 | 2017-07-18 | 2018-10-17 |
| A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study GVGH Shigella sonnei 1790GAHB vaccine - Dysentery, Bacillary | Phase 1 | Completed | GlaxoSmithKline | 35 | 2017-03-16 | 2019-06-28 |
| Shigella WRSS1 Vaccine Trial in Bangladesh Shigella sonnei Strain WRSS1 Vaccine, Placebo - Diarrhea | Phase 1 | Completed | PATH | 16 | 2017-02-23 | 2020-03-31 |
| Dose-Finding Study of Lyophilized Shigella Sonnei 53G Challenge Strain Shigella sonnei 53G - Healthy | Phase 1 | Completed | PATH | 56 | 2016-09-12 | 2019-06-03 |
| SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers SF2a-TT15 vaccine, SF2a-TT15 vaccine + adjuvant, Placebo - Shigellosis, Bacillary Dysentery | Phase 1 | Completed | Institut Pasteur | 64 | 2016-09-01 | 2018-04-11 |
| Phase 1 Study of dmLT ID Vaccination in Healthy Adults Placebo, Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine - Gastroenteritis Escherichia Coli | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 100 | 2016-06-02 | 2020-10-26 |
| Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR) Shigella flexneri 2a InvaplexAR - Shigellosis, Bacillary Dysentery | Phase 1 | Completed | U.S. Army Medical Research and Development Command | 38 | 2015-10-01 | 2021-02-12 |
| Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a Flexyn2a, Placebo, Flexyn2a plus adjuvant - Shigellosis | Phase 1 | Completed | LimmaTech Biologics AG | 30 | 2015-02-01 | 2015-12-22 |
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Diarrhea (6) · Dysentery (4) · Gastrointestinal Diseases (2) · Arthritis, Reactive (1) · Bacterial Infections (1) · Digestive System Diseases (1) · Enterobacteriaceae Infections (1) · Escherichia coli Infections (1) · Gastroenteritis (1) · Gram-Negative Bacterial Infections (1) · Intestinal Diseases (1)
Bacterial Infections and Mycoses (31) · Infections (31) · Bacterial Infections (30) · Digestive System Diseases (30) · Enterobacteriaceae Infections (30) · Gastroenteritis (30) · Gram-Negative Bacterial Infections (30) · Intestinal Diseases (30) · Gastrointestinal Diseases (29) · Dysentery (27) · Pathological Conditions, Signs and Symptoms (7) · Signs and Symptoms (6) · Signs and Symptoms, Digestive (6) · Arthritis (1) · Arthritis, Infectious (1)
Vaccines (4) · Adjuvants, Pharmaceutic (2) · Boostrix (1) · Ciprofloxacin (1) · MenACWY (1) · Meningococcal Vaccines (1) · Shigella Vaccines (1) · Sodium Chloride (1) · Tetanus Toxoid (1) · Vi polysaccharide vaccine, typhoid (1) · diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (1)
PATH (5) · U.S. Army Medical Research and Development Command (4) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (2) · Eveliqure Biotechnologies GmbH (2) · GSK Vaccines Institute For Global Health S.r.l. (2) · GlaxoSmithKline (2) · LimmaTech Biologics AG (2) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · University of Maryland, Baltimore (2) · Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd (1) · GlycoVaxyn AG (1) · Institut Pasteur (1) · International Vaccine Institute (1) · Intralytix, Inc. (1) · Inventprise Inc. (1)
United States (14) · Kenya (3) · Bangladesh (2) · France (2) · Israel (2) · Belgium (1) · China (1) · Hungary (1) · Netherlands (1) · Switzerland (1) · Thailand (1) · United Kingdom (1)
Alexander Sulakvelidze, PhD (1) · Carl Mason, MD (1) · Christoph Hatz, Prof. Dr. (1) · Christopher Duplessis, MD, MPH, MS (1) · Clayton D Harro, MD, ScM (1) · David JM Lewis, MD (1) · David Tribble, MD, PhD (1) · Feng-Ying C Lin, M.D. (1) · Germaine M Louis, M.D. (1) · Josphat Kosgei, MD (1) · Karen L. Kotloff, M.D. (1)
PMID 27490698, PMID 28735965, PMID 34017343, PMID 20619378, PMID 26162850, PMID 26865592, PMID 27146000, PMID 27581434, PMID 29534721, PMID 33186516, PMID 33207794, PMID 34793505, PMID 37666695, PMID 38853614, PMID 39852827, PMID 39893179, PMID 40152601, PMID 41999631
2016 (1)