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

NCT07467707 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6144

Last updated 2026-03-16

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • United States Department of Defense

    collaborator FED

  • Pharmaceutical Product Development, (PPD) LLC

    collaborator INDUSTRY

  • Armed Forces Research Institute of Medical Services

    collaborator NETWORK

  • Q-square Business Intelligence, Inc.

    collaborator INDUSTRY

  • Bavarian Nordic

    lead INDUSTRY

Principal Investigators

  • Patrick Ajiboye, MD · Bavarian Nordic A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • Philippines
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07467707 on ClinicalTrials.gov