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Chikungunya

Phase 2

Chikungunya | Monoclonal antibody | Infectious Disease |Emergent BioSolutions Inc.|Last Updated: Oct 16, 2024

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Chikungunya · 1 trial · 1 indication

Phase 2 1
NCT03992872Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)Chikungunya
COMPLETED60 Analytics
PHASE2COMPLETED
Phase 2 Open-label Study of Alum-adjuvanted Chikungunya Virus-like Particle Vaccine (PXVX0317)
ChikungunyaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Day 22 (21 days after vaccination)

Seroconversion, defined as a 4-fold or greater rise in neutralizing antibody against chikungunya virus, as determined by luciferase-based assay (NT80), induced by PXVX0317. PXVX0317 was administered to prior alphavirus vaccine recipients versus gender- and age-matched controls.

Secondary Endpoints

Geometric Mean Titer of Anti-CHIKV Neutralizing Antibody Response
Day 1, 8, 22, 29, 57, 182
Percentage of Participants With 4-fold Rise in Anti-CHIKV Neutralizing Antibody Response
Day 8, 29, 57, 182
Percentage of Participants With Anti-CHIKV Neutralizing Antibody at or Above Selected Thresholds
Day 1, 8, 22, 29, 57, 182
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Prior AlphaEXPERIMENTALAll study participants received the same Investigational Product according to the same schedule. Participants were prior recipients of experimental alphavirus vaccines.
Control: Naïve AlphaACTIVE_COMPARATORAll study participants received the same Investigational Product according to the same schedule. The alphavirus vaccine naïve participants will serve as controls for determining the effect of pre-existing alphavirus immunity on vaccine safety and immunogenicity.

Interventions

NameTypeDescription
ChikungunyaBIOLOGICALVirus Like Particle
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Age 18 to 65 years old (inclusive) * For women of childbearing potential, a negative pregnancy test at screening and on vaccination day, practicing highly effective contraception for at least 30 days prior to vaccination, and willing to use a highly effective method of contrac...

Countries:United States
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Frequently asked questions about Chikungunya

What is Chikungunya used for?

Chikungunya is an investigational monoclonal antibody being developed by Emergent BioSolutions Inc. (EBS) for the prevention or treatment of chikungunya, a viral infectious disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Chikungunya?

Emergent BioSolutions Inc. (ticker: EBS) is developing Chikungunya, a monoclonal antibody for chikungunya. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with the infectious disease.

What phase is Chikungunya in?

Chikungunya is in Phase 2 clinical development. It is an investigational monoclonal antibody being studied for chikungunya. The drug is not yet approved and remains in clinical trials to assess its safety and effectiveness.

What clinical trials is Chikungunya in?

Chikungunya has one completed Phase 2 clinical trial, NCT03992872, which was an open-label study of an alum-adjuvanted chikungunya virus-like particle vaccine (PXVX0317) in 60 healthy volunteers in the United States. The trial was active-controlled and enrolled adults aged 18 years and older.

Is Chikungunya the same as PXVX0317?

Yes, Chikungunya is also known as PXVX0317. In clinical trial NCT03992872, the drug was studied as an alum-adjuvanted chikungunya virus-like particle vaccine. This alternative name may appear in scientific literature and trial registries.