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Biological Vaccine VLA1553

Phase 3

Chikungunya Virus Infection | Monoclonal antibody | Other |Valneva SE|Last Updated: Sep 28, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment409
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04786444Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy AdultsPHASE3 COMPLETED 409 — — Feb 22, 2021Jan 26, 2022Sep 28, 202312 United States
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Study Endpoints
Primary Endpoints
Geometric Mean Titer (GMT) of CHIKV-specific Neutralizing Antibodies as Determined by Microneutralization (μPRNT) Assay in Subjects Who Tested Negative for CHIKV Antibodies at Baseline
On Day 29 after single vaccination
Secondary Endpoints
Immune Response as Measured by CHIKV-specific Neutralizing Antibody Titers
on Day 8, 85 and Month 6
Proportion of Subjects With Seroprotective Levels for Baseline Negative Subjects
on Day 8, 29, 85 and Month 6
Proportion of Subjects With Seroconversion
on Day 29, Day 85 and Month 6
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
VLA1553 Lot 1ACTIVE_COMPARATOR -
VLA1553 Lot 2ACTIVE_COMPARATOR -
VLA1553 Lot 3ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Biological Vaccine VLA1553BIOLOGICALSingle intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites12

Inclusion Criteria: 1. 18 to 45 years of age on the Day of screening 2. Able to provide informed consent 3. Generally healthy as determined by the Investigator's clinical judgement based on medical history, physical examination and screening laboratory tests 4. For women of childbearing potential: ...

Countries:United States
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