Approval Probability
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Adjusted LOA
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Also known as heat-labile enterotoxin of E. coli (LT)
heat-labile enterotoxin of E. coli · 4 trials · 3 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. |
| 5 | EXPERIMENTAL | 37.5µg LT Dose placed at the Deltoid on Day 0 and Day 21 |
| 6 | EXPERIMENTAL | 37.5µg LT Dose placed at the Lower Back on Day 0 and Day 21 |
| 7 | EXPERIMENTAL | 50µg LT Dose placed at the Deltoid on Day 0 and Day 21 |
| 8 | EXPERIMENTAL | 50µg LT Dose placed at the Lower Back on Day 0 and Day 21 |
| 9 | PLACEBO_COMPARATOR | Placebo (0µg LT) placed at the Deltoid on Day 0 and Day 21 |
| 10 | PLACEBO_COMPARATOR | Placebo (0µg LT) placed at the Lower Back on Day 0 and Day 21 |
| Name | Type | Description |
|---|---|---|
| Heat-Labile Enterotoxin of E. coli (LT) | BIOLOGICAL | Travelers' Diarrhea Vaccine System |
| Placebo | BIOLOGICAL | Travelers' Diarrhea Vaccine System |
| Biological: heat-labile enterotoxin of E. coli (LT) | BIOLOGICAL | LT patch applied on either the deltoid or the lower back. |
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 being developed for the prevention of travelers' diarrhea. It is also studied in diarrhea prevention more broadly. The candidate is designed as a vaccine patch approach against enterotoxigenic E. coli, a leading cause of acute diarrheal illness in travelers visiting endemic regions.
Valneva SE, which trades under the ticker VALN, is the developer of the heat-labile enterotoxin of E. coli vaccine candidate. The company has advanced the program through Phase 2 clinical testing in the United States, evaluating it for prevention of travelers' diarrhea in adult healthy volunteers.
Heat-labile enterotoxin of E. coli is in Phase 2 clinical development. All reported trials for this candidate have been Phase 2 studies, and the program has completed its trials to date. It is an investigational product and has not been approved for commercial use.
Four Phase 2 trials have evaluated heat-labile enterotoxin of E. coli: NCT01067781, a safety and immunogenicity study of a travelers' diarrhea vaccine patch with 600 participants; NCT00751777, a travelers' diarrhea automated process study with 120 participants; NCT00672035, a randomized, double-blind, placebo-controlled safety and efficacy study with 406 participants; and NCT00565461, an LT vaccine patch self-administration study with 160 participants.
Yes. Heat-labile enterotoxin of E. coli is also known as LT, and the two names refer to the same vaccine candidate. Other variations used include heat-labile enterotoxin of E. coli (LT) and Heat-Labile Enterotoxin of E. coli (LT). All describe the same Phase 2 travelers' diarrhea program developed by Valneva SE.
The trials were randomized, double-blind, and placebo-controlled, enrolling healthy adult volunteers aged 18 years and older of all sexes in the United States. Across the completed Phase 2 studies, total enrollment reached approximately 600 participants in the largest trial, with the program evaluating safety and immunogenicity for travelers' diarrhea prevention.