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Biological Vaccine VLA1553

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment409

FDA Designations

No designations recorded

Clinical trial landscape

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 an investigational vaccine candidate being developed for the prevention of Chikungunya virus infection. It is a live-attenuated vaccine designed to protect against the mosquito-borne viral disease. The vaccine is currently in clinical development and has not been approved by regulatory authorities.

Who makes VLA1553?

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 efficacy of this vaccine candidate for Chikungunya virus infection.

What phase is VLA1553 in?

VLA1553 is in Phase 3 clinical development. It is an investigational vaccine candidate and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the vaccine remains under evaluation for the prevention of Chikungunya virus infection.

What clinical trials is VLA1553 in?

VLA1553 has been evaluated in one completed Phase 3 clinical trial registered as NCT04786444. This study, titled 'Study to Demonstrate Consistency of Three Lots of a Live-attenuated Chikungunya Virus Vaccine Candidate in Healthy Adults,' enrolled 409 participants in the United States. The trial was randomized, double-blind, and active-controlled.

Is VLA1553 the same as a live-attenuated chikungunya vaccine?

Yes, VLA1553 is a live-attenuated chikungunya virus vaccine candidate. It is designed to elicit an immune response against the Chikungunya virus. The vaccine is being developed by Valneva SE and has completed a Phase 3 clinical trial to evaluate its consistency and immunogenicity in healthy adults.