NCT07467707

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)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,144 (estimated)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chikungunya Virus

Interventions

Type	Name	Description
BIOLOGICAL	CHIKV 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.
BIOLOGICAL	Placebo	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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-05-01
• Completion: 2030-05-01
• First posted: 2026-03-12
• Last updated: 2026-03-16

Locations

3 sites across 2 countries: Philippines, Thailand

Regulatory

• FDA-regulated drug study