Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VLA1553 · 3 trials · 2 indications
Data for Visit 1 - Day 1 are collected from Trial VLA1553-301
Seroprotection rate, based on a surrogate of protection agreed with FDA Assay used for analysis was based on µPRNT (Micro Plaque Reduction Neutralization Test). Participants at pre-selected sites were included, if they had available Day 1 and Day 29 samples and without major protocol deviations that could impact the immune response.
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007)
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner
Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales
| Arm | Type | Description |
|---|---|---|
| VLA1553 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo |
| VLA1553 low dose | ACTIVE_COMPARATOR | VLA1553 with 3.2x10\^3 TCID50/ 100 µL (microliter). Re-vaccination at Month 12 with VLA1553 with 3.2x10\^5 TCID50/ 1 mL (milliliter) |
| VLA1553 medium dose | ACTIVE_COMPARATOR | VLA1553 with 3.2x10\^4 TCID50/ 1 mL Re-vaccination at Month 12 with VLA1553 with 3.2x10\^5 TCID50/ 1 mL |
| VLA1553 high dose | ACTIVE_COMPARATOR | VLA1553 with 3.2x10\^5 TCID50/ 1 mL Re-vaccination at Month 6 or Month 12 with VLA1553 with 3.2x10\^5 TCID50/ 1 mL |
| Name | Type | Description |
|---|---|---|
| VLA1553 | BIOLOGICAL | Trial participants previously vaccinated with VLA1553 in trial VLA1553-301 will be followed up for safety and immunogenicity. |
| Placebo | BIOLOGICAL | Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo |
Inclusion Criteria: * Individual participated in the VLA1553-301 clinical trial; * Participant has an understanding of the trial and its procedures, agrees to its provisions, and voluntarily gives written informed consent prior to any trial-related procedures; * Participant had immunogenicity blood...
VLA1553 is an investigational vaccine candidate being developed for the prevention of Chikungunya and Chikungunya Virus Infection. It is a live-attenuated vaccine designed to elicit an immune response against the chikungunya virus. The vaccine is currently in clinical development and has not been approved by regulatory authorities.
VLA1553 is being developed by Valneva SE, a biopharmaceutical company. Valneva is publicly traded on the NASDAQ under the ticker symbol VALN. The company is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine candidate in healthy adult volunteers.
VLA1553 has completed Phase 1 and Phase 3 clinical trials, and an additional Phase 3 trial is active but not recruiting participants. The vaccine candidate is investigational and remains in clinical development. It has not been approved by the U.S. Food and Drug Administration or any other regulatory agency.
VLA1553 has been studied in three clinical trials. NCT03382964 was a Phase 1 study in 120 healthy volunteers. NCT04546724 was a pivotal Phase 3 study in 4,128 adults. NCT04838444 is an active Phase 3 trial with 363 participants assessing antibody persistence and long-term safety. All trials were conducted in the United States.
VLA1553 is a chikungunya virus vaccine candidate specifically developed to prevent Chikungunya and Chikungunya Virus Infection. It is a live-attenuated vaccine, meaning it uses a weakened form of the virus to trigger an immune response. No alternative names for VLA1553 have been disclosed.