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Biological Vaccine VLA1553

Phase 3

Chikungunya Virus Infection | Vaccine | Infectious Disease |Valneva SE|Trials Updated: Sep 28, 2023

Biological Vaccine VLA1553 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Mar 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment409

FDA Designations

No designations recorded

Biological Vaccine VLA1553 clinical trials

Biological Vaccine VLA1553 · 1 trial · 1 indication

Phase 3 1
NCT04786444Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy AdultsChikungunya Virus Infection
COMPLETED409 Analytics
PHASE3COMPLETED
Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults
Chikungunya Virus InfectionUnlock trial analytics

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 to 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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Frequently asked questions about Biological Vaccine VLA1553

What is VLA1553 used for?

VLA1553 is a vaccine candidate being developed for the prevention of Chikungunya virus infection. It is a live-attenuated vaccine designed to protect healthy adults against the disease. Valneva SE is developing it as a biological vaccine, and it is currently in Phase 3 clinical development.

Who is developing VLA1553?

VLA1553 is being developed by Valneva SE, a biopharmaceutical company whose ticker symbol is VALN. Valneva is the sponsor of the clinical program evaluating this live-attenuated Chikungunya vaccine candidate in healthy adult volunteers.

What phase is VLA1553 in?

VLA1553 is in Phase 3 clinical development. It is an investigational vaccine candidate and has not been approved. The Phase 3 trial evaluating the consistency of three lots of the vaccine has been completed, with 409 participants enrolled.

What clinical trials is VLA1553 in?

VLA1553 has been studied in a Phase 3 clinical trial, NCT04786444, titled a study to demonstrate consistency of three lots of a live-attenuated Chikungunya virus vaccine candidate in healthy adults. The trial enrolled 409 participants in the United States, was randomized, double-blind, and active-controlled, and is now completed.

What is VLA1553?

VLA1553 is a live-attenuated biological vaccine candidate developed by Valneva SE for Chikungunya virus infection. It is an investigational product in Phase 3 development, studied in healthy adults aged 18 years and older, and is designed to prevent Chikungunya virus infection.