6 completed. 5 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 5 |
| Phase 2 | 3 | Completed 3 |
Follow dmLT: new trials by email Literature Review of dmLT trials Research Report on dmLT
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 |
|---|---|---|---|---|---|---|
| Efficacy Study of IM Administered CssBA+dmLT Against Moderate-severe Diarrhea in Human Infection Model With ETEC Strain B7A in Healthy Adults B7A (ETEC challenge strain), CssBA, dmLT - Escherichia Infection | Phase 2 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 72 | 2025-03-31 | 2026-04-17 |
| A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel® - HIV Infections | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 143 | 2021-03-15 | 2025-03-26 |
| Evaluation of Safety, Reactogenicity and Immunogenicity of Fractional-dose Inactivated Polio Vaccine (fIPV) Given Intradermally With Double Mutant Enterotoxigenic Escherichia Coli Heat Labile Toxin (dmLT) Adjuvant dmLT, fIPV - Polio | Phase 1 | Completed | University of Vermont | 29 | 2019-03-19 | 2020-08-05 |
| Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC) CssBA, dmLT - Diarrhea | Phase 1 | Completed | PATH | 50 | 2018-01-16 | 2021-01-06 |
| Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh ETVAX, dmLT, Bicarbonate Buffer - Escherichia Coli Diarrhea | Phase 1 / Phase 2 | Completed | PATH | 475 | 2015-10-01 | 2018-09-12 |
| Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults ACE527, dmLT, CeraVacx placebo - Diarrhea | Phase 1 / Phase 2 | Completed | PATH | 81 | 2012-09-01 | 2019-02-12 |
Diarrhea (3) · Escherichia coli Infections (2) · HIV Infections (1) · Poliomyelitis (1)
PATH (3) · National Institute of Allergy and Infectious Diseases (NIAID) (2) · University of Vermont (1)
United States (4) · Bangladesh (1) · Kenya (1)
Beth Kirkpatrick, M.D. (1) · Christina Polyak, MD (1) · Clayton D Harro, MD, ScM (1) · Josphat Kosgei, MBChB, MSc (1) · Kelly Cowan, M.D. (1) · Sandhya Vasan, MD (1) · Tida K Lee, MD, PhD (1)
PMID 30473185, PMID 30797634, PMID 31757774, PMID 35367069, PMID 35536001
5UM1AI148684-04 (1)