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CHIKV VLP vaccine

Phase 3

Chikungunya Virus | Monoclonal antibody | Infectious Disease |United Therapeutics Corporation|Last Updated: Mar 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6,144

FDA Designations

No designations recorded

Clinical trial landscape

CHIKV VLP vaccine · 1 trial · 1 indication

Phase 3 1
NCT07467707An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and AdultsChikungunya Virus
NOT YET_RECRUITING6,144 Analytics
PHASE3NOT YET_RECRUITING
An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and Adults
Chikungunya VirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of laboratory-confirmed acute CHIKV disease
From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination

Laboratory-confirmed acute CHIKV disease is defined by the presence of fever, one or more of arthralgia, myalgia or rash, and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) confirmation of CHIKV ribonucleic acid.

Secondary Endpoints

Incidence of laboratory-confirmed chronic CHIKV disease
98 days postvaccination through end of study follow-up, up to 1095 days postvaccination
Incidence of laboratory-confirmed severe CHIKV disease.
14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
Number of participants with Solicited or Local Adverse Events
Within 7 days postvaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1: Cohort 1 Active GroupACTIVE_COMPARATORCHIKV VLP/adjuvant
Arm 2: Cohort 1 Placebo GroupPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
CHIKV VLP vaccineBIOLOGICALCHIKV VLP vaccine is comprised of 40 µg CHIKV VLP adsorbed on aluminum hydroxide (corresponding to approximately 300 µg of aluminum and stabilized with formulation buffer). CHIKV VLP vaccine is supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
PlaceboBIOLOGICALPlacebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: 1. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must verbalize understanding of the reason for and the procedures needed for the study and be willing to stay in the study for its entire ...

Countries:PhilippinesThailand
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT07467707studyFirstPostDate: changed

Frequently asked questions about CHIKV VLP vaccine

What is CHIKV VLP vaccine used for?

CHIKV VLP vaccine is an investigational vaccine being studied for the prevention of chikungunya disease in adolescents and adults. It is currently in Phase 3 clinical development for the Chikungunya Virus indication, which falls under the Infectious Disease therapeutic area.

Who makes CHIKV VLP vaccine?

CHIKV VLP vaccine is being developed by United Therapeutics Corporation, a company traded on the NASDAQ under the ticker symbol UTHR. The vaccine is currently in Phase 3 clinical development for the prevention of chikungunya disease.

What phase is CHIKV VLP vaccine in?

CHIKV VLP vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 3 trial is designed to evaluate the efficacy, safety, and immunogenicity of the vaccine for the prevention of chikungunya disease.

What clinical trials is CHIKV VLP vaccine in?

CHIKV VLP vaccine is being evaluated in a single Phase 3 clinical trial registered as NCT07467707. This randomized, double-blind, placebo-controlled study is assessing the efficacy, safety, and immunogenicity of the vaccine for the prevention of chikungunya disease in adolescents and adults, with an enrollment target of 6,144 participants.

Is CHIKV VLP vaccine the same as a chikungunya vaccine?

CHIKV VLP vaccine is a vaccine candidate specifically designed to prevent chikungunya disease caused by the Chikungunya Virus. It is a virus-like particle (VLP) vaccine, which is a type of vaccine that mimics the structure of the virus to elicit an immune response without causing the disease.