RecruitingPhase 3NCT07467707

An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and Adults

A Phase 3b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Adjuvanted Chikungunya Virus Virus-like Particle (CHIKV VLP) Vaccine for the Prevention of Chikungunya Disease in Adolescents (12 to <18 Years) and Adults (≥18 Years)


Sponsor

Bavarian Nordic

Enrollment

6,144 participants

Start Date

May 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Study EBSI-CV-317-007 is a field study to evaluate the efficacy, immunogenicity, and safety of CHIKV VLP vaccine. The study was designed using infectious disease models and advanced analytics to guide region and clinical site prioritization, define the timing of study activities, and optimize the study parameters to local epidemiological conditions for CHIKV disease to overcome the challenges of assessing efficacy for CHIKV VLP vaccine.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called CHIKV VLP vaccine and a biological treatment called Placebo for people with chikungunya virus. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCHIKV VLP vaccine

CHIKV 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.

BIOLOGICALPlacebo

Placebo 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.


Locations(3)

WRAIR-AFRIMS Philippines, Cebu (WRAIR-APC)

Cebu City, Cebu, Philippines

Kamphaeng Phet Provincial Hospital

Kamphaeng Phet, Changwat Kamphaeng Phet, Thailand

Songklanagarind hospital, Prince of Songkla University (PSU)

Hat Yai, Changwat Songkhla, Thailand

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NCT07467707


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