Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VLA84 · 1 trial · 1 indication
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;
| Arm | Type | Description |
|---|---|---|
| VLA84 75 mcg (microgram) w/o Alum | ACTIVE_COMPARATOR | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections |
| VLA84 200 mcg w/o Alum | ACTIVE_COMPARATOR | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections |
| VLA84 200 mcg with Alum | ACTIVE_COMPARATOR | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections |
| Placebo | PLACEBO_COMPARATOR | Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections |
| Name | Type | Description |
|---|---|---|
| VLA84 | BIOLOGICAL | a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
| Placebo | BIOLOGICAL | phosphate buffered saline (PBS) solution |
Inclusion Criteria: * Subjects aged ≥50 years of good general health, including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, or type 2 diabetes mellitus. * Informed consent form has been signed and dated Exclusion Criteria: * Subjects with any con...
VLA84 is an investigational monoclonal antibody being developed for the prevention of Clostridium difficile infection. It is designed for use in adults aged 50 years and older, a population at increased risk for this infectious disease. The drug is currently in clinical development and has not been approved by regulatory authorities.
VLA84 is being developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker VALN. Valneva is conducting clinical trials to evaluate the safety and immunogenicity of this investigational monoclonal antibody for Clostridium difficile.
VLA84 is in Phase 2 clinical development. A Phase 2 study has been completed, evaluating the drug in healthy adults aged 50 years and older. The drug is investigational and has not received regulatory approval for any use.
VLA84 has been studied in one completed Phase 2 clinical trial, identified as NCT02316470. This was a dose-confirmation, immunogenicity, and safety study conducted in the United States and Germany, enrolling 500 healthy adults aged 50 years and older. The trial was randomized, double-blind, and placebo-controlled.
VLA84 is a monoclonal antibody, a type of biologic drug that targets specific proteins in the body. While the exact molecular target is not specified, monoclonal antibodies are designed to bind to particular antigens, potentially neutralizing the toxin produced by Clostridium difficile bacteria to prevent infection.