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 for the prevention of chikungunya and chikungunya virus infection. It is being developed as a live-attenuated vaccine to generate an immune response against the chikungunya virus. The vaccine is currently in clinical development and is not yet approved by regulatory authorities.
VLA1553 is being developed by Valneva SE, a biopharmaceutical company traded on the NASDAQ under the ticker symbol VALN. Valneva is conducting clinical trials to evaluate the safety and immunogenicity of the vaccine candidate in healthy adult volunteers.
VLA1553 is in Phase 3 clinical development. The pivotal Phase 3 study (NCT04546724) has been completed, and a long-term follow-up study (NCT04838444) is active but not recruiting. An earlier Phase 1 study (NCT03382964) was also completed. The vaccine remains investigational and has not received FDA approval.
VLA1553 has been studied in three clinical trials. NCT03382964 was a Phase 1 study in 120 healthy volunteers in the United States. NCT04546724 was a pivotal Phase 3 study in 4,128 adults. NCT04838444 is an active Phase 3 study evaluating antibody persistence and long-term safety in 363 participants.
VLA1553 is a live-attenuated vaccine designed to induce an immune response against the chikungunya virus. By presenting weakened virus components to the immune system, it aims to stimulate the production of antibodies that can neutralize the virus and provide protection against chikungunya infection.
VLA1553 is a chikungunya virus vaccine candidate. It is specifically designed to prevent chikungunya and chikungunya virus infection. The vaccine is being developed by Valneva SE and is currently in Phase 3 clinical trials, with studies completed or ongoing in the United States.