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Heat-Labile Enterotoxin of E. coli · 3 trials · 2 indications
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.
GMFRs relative to the baseline titer were determined at each post-baseline time point. All GMFRs were based on log10-transformed data.
Definition of SCR: * Seroconversion IgG: ≥ 2-fold rise of LT IgG titer relative to baseline * Seroconversion IgA: ≥ 4-fold rise of LT IgA titer relative to baseline
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMFR: geometric mean fold ratio GMFRs relative to the baseline titer were determined for LT IgG and LT IgA at each post-baseline time point. All GMFRs were based on log10-transformed data.
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates (SCR) for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. seroconversion (SC): two-fold or greater rise in titer relative to Day 0 for LT IgG and a four-fold or greater rise in titer relative to Day 0 for LT IgA
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Two vaccination regimen with an LT patch (no swabbing) |
| 2 | EXPERIMENTAL | Two vaccination regimen with an LT patch (with swabbing) |
| 3 | PLACEBO_COMPARATOR | Two vaccination regimen with a placebo patch (no swabbing) |
| 4 | PLACEBO_COMPARATOR | Two vaccination regimen with a placebo patch (with swabbing) |
| Group 1: 37.5 µg LT patch | EXPERIMENTAL | 80 subjects will receive a two vaccination regimen with a LT patch. |
| Group 2: 0 µg LT patch (placebo) | PLACEBO_COMPARATOR | 40 subjects will receive a two vaccination regimen with a placebo patch. |
| Group 1 | EXPERIMENTAL | 40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician |
| Group 2 | EXPERIMENTAL | 40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician. |
| Group 3 | EXPERIMENTAL | 40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh. |
| Group 4 | EXPERIMENTAL | 40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh. |
| Name | Type | Description |
|---|---|---|
| Heat-Labile Enterotoxin of E. coli (LT) | BIOLOGICAL | Travelers' Diarrhea Vaccine System |
| Placebo | BIOLOGICAL | Travelers' Diarrhea Vaccine System |
Inclusion Criteria: 1. A female or male 18-64 (inclusive) years of age; 2. In good health as determined by medical history and screening exam; 3. Females who are post-menopausal, surgically sterile, or have a negative serum/urine pregnancy test at Day 0 and agree not to become pregnant for the dura...
Heat-Labile Enterotoxin of E. coli is an investigational vaccine being developed for the prevention of travelers' diarrhea and diarrhea. It is designed to be administered via a patch. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Valneva SE (ticker: VALN) is developing Heat-Labile Enterotoxin of E. coli. The company is conducting clinical trials for this vaccine candidate, which is intended for the prevention of travelers' diarrhea and diarrhea.
Heat-Labile Enterotoxin of E. coli is in Phase 2 clinical development. It is an investigational vaccine and has not received regulatory approval. The clinical trials for this drug have been completed, and it is not currently in active trials.
Heat-Labile Enterotoxin of E. coli has been studied in three completed Phase 2 trials: NCT00565461, NCT00751777, and NCT01067781. These trials enrolled healthy adults aged 18 years and older in the United States and evaluated the vaccine for the prevention of travelers' diarrhea and diarrhea.
Heat-Labile Enterotoxin of E. coli is administered as a patch, as indicated by the clinical trial titles. The trials evaluated the vaccine patch for safety, immunogenicity, and self-administration. This delivery method is part of the investigational product being developed by Valneva SE.