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Also known as Heat-Labile Enterotoxin of Escherichia coli (LT)
Heat-Labile Enterotoxin of Escherichia coli · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT |
| Group 2 | PLACEBO_COMPARATOR | Group 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT) |
| Name | Type | Description |
|---|---|---|
| Heat-Labile Enterotoxin of Escherichia coli (LT) | BIOLOGICAL | Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart. |
| Placebo | BIOLOGICAL | The placebo patch contains all of the components of the active patch, but with no LT included in the formulation. |
Inclusion Criteria: * Healthy adult men and women 18-64 years of age inclusive at screening * Signed Informed Consent form * Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days) * If female who is not post-...
Heat-Labile Enterotoxin of Escherichia coli is being developed for the prevention of diarrhea. It is a monoclonal antibody candidate from Valneva SE, studied in a Phase 2 trial in healthy adult volunteers. The research targets diarrheal illness associated with enterotoxigenic Escherichia coli, a common cause of travelers' diarrhea.
Heat-Labile Enterotoxin of Escherichia coli is being developed by Valneva SE, which trades under the ticker VALN. The company sponsored the Phase 2 ETEC Logistics Trial (TREK) evaluating the candidate in healthy volunteers across the United States, Guatemala, and Mexico.
Heat-Labile Enterotoxin of Escherichia coli is in Phase 2 development. The single recorded trial, NCT00516659, is a completed Phase 2 study. The candidate is investigational and has not been approved by the FDA for any indication.
Heat-Labile Enterotoxin of Escherichia coli has been studied in one clinical trial, NCT00516659, also called the ETEC Logistics Trial (TREK). This completed Phase 2 study enrolled 201 healthy adult volunteers aged 18 years and older in the United States, Guatemala, and Mexico. It was randomized, double-blind, and placebo-controlled.
Yes. Heat-Labile Enterotoxin of Escherichia coli is also known as LT, short for heat-labile enterotoxin. Both names refer to the same Valneva SE monoclonal antibody candidate studied in the Phase 2 ETEC Logistics Trial (TREK) for diarrhea.