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

NCT07467707 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: EBSI-CV-317-007
• Study Type: interventional
• Target: 6,144
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

Chikungunya; PXVX0317; CHIKV VLP; vaccine; immunogenicity; efficacy; safety; VIMKUNYA; adolescents; adults

Outcome Measures

Primary Outcomes (1)

• Incidence of laboratory-confirmed acute CHIKV disease

  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.

  From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination

Secondary Outcomes (9)

• 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

• Number of participants with Unsolicited Adverse Events

  Within 28 days postvaccination

• Number of Participants with Serious Adverse Events

  Through end of study follow-up, up to 1095 days postvaccination

Study Arms (2)

Arm 1: Cohort 1 Active Group

ACTIVE COMPARATOR

CHIKV VLP/adjuvant

Biological: CHIKV VLP vaccine

Arm 2: Cohort 1 Placebo Group

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

CHIKV VLP vaccine BIOLOGICAL

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.

Arm 1: Cohort 1 Active Group

Placebo BIOLOGICAL

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.

Arm 2: Cohort 1 Placebo Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 duration.
• Male or nonpregnant female 12 years of age and older.
• In stable health per the investigator, and no hospital admission or major surgical procedure in the last 30 days before investigational product administration.
• Women who are either:
• Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment). or
• Meeting all the below criteria:
• Negative urine pregnancy test at screening visit
• Negative urine pregnancy test immediately prior to dosing
• Using an acceptable form of contraception per local standards and agree to use this for at least 8 weeks after investigational product administration
• Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for at least 8 weeks after investigational product administration.

You may not qualify if:

• Currently pregnant or breastfeeding.
• Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for the duration of the study. Note: Participation in an observational trial/study or follow-up phase of a trial/study may be eligible; however, participation in any other study should be discussed with the MM prior to enrollment.
• History of severe allergic reaction or anaphylaxis to any component of the investigational product.
• Prior receipt of any CHIKV vaccine (or therapeutic) or participation in a prior interventional CHIKV trial/study.
• Prior documented, laboratory confirmed CHIKV disease.
• Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit.
• Unstable medical condition in the last 30 days prior to Day 1.
• Acute illness with or without fever (oral temperatures ≥38.0 ºC \[100.4 °F\]) within 14 days prior to investigational product administration.
• Medical or social condition (eg, substance abuse) that could have an impact on the participant's ability to be compliant with study procedures/visits, as determined by the investigator.
• Plans to travel outside the study area or move away for more than 3 consecutive months and will not be available for follow up at the site.
• Identified as an investigator or employee of an investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study, or identified as an employee of Bavarian Nordic, their families, contractors, agents, business partners, or anyone with a financial interest in the outcome of the study.
• Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.

Sponsors & Collaborators

• Bavarian Nordic: lead
• Walter Reed Army Institute of Research (WRAIR): collaborator
• Congressionally Directed Medical Research Programs: collaborator
• United States Department of Defense: collaborator
• Pharmaceutical Product Development, (PPD) LLC: collaborator
• Armed Forces Research Institute of Medical Services: collaborator
• Q-square Business Intelligence, Inc.: collaborator

Study Sites (3)

WRAIR-AFRIMS Philippines, Cebu (WRAIR-APC)

Cebu City, Cebu, 6000, Philippines

RECRUITING

Kamphaeng Phet Provincial Hospital

Kamphaeng Phet, Changwat Kamphaeng Phet, 62000, Thailand

RECRUITING

Songklanagarind hospital, Prince of Songkla University (PSU)

Hat Yai, Changwat Songkhla, 90110, Thailand

NOT YET RECRUITING

Related Publications (4)

• Bennett SR, McCarty JM, Ramanathan R, Mendy J, Richardson JS, Smith J, Alexander J, Ledgerwood JE, de Lame PA, Royalty Tredo S, Warfield KL, Bedell L. Safety and immunogenicity of PXVX0317, an aluminium hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial. Lancet Infect Dis. 2022 Sep;22(9):1343-1355. doi: 10.1016/S1473-3099(22)00226-2. Epub 2022 Jun 13.

  PMID: 35709798 BACKGROUND

• McCarty JM, Bedell L, Mendy J, Coates EE, Chen GL, Ledgerwood JE, Tredo SR, Warfield KL, Richardson JS. Chikungunya virus virus-like particle vaccine is well tolerated and immunogenic in chikungunya seropositive individuals. Vaccine. 2023 Oct 6;41(42):6146-6149. doi: 10.1016/j.vaccine.2023.08.086. Epub 2023 Sep 9.

  PMID: 37690874 BACKGROUND

• Richardson JS, Anderson DM, Mendy J, Tindale LC, Muhammad S, Loreth T, Tredo SR, Warfield KL, Ramanathan R, Caso JT, Jenkins VA, Ajiboye P, Bedell L; EBSI-CV-317-004 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1343-1352. doi: 10.1016/S0140-6736(25)00345-9. Epub 2025 Mar 27.

  PMID: 40158526 BACKGROUND

• Tindale LC, Richardson JS, Anderson DM, Mendy J, Muhammad S, Loreth T, Tredo SR, Ramanathan R, Jenkins VA, Bedell L, Ajiboye P; EBSI-CV-317-005 Study Group. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial. Lancet. 2025 Apr 19;405(10487):1353-1361. doi: 10.1016/S0140-6736(25)00372-1. Epub 2025 Mar 27.

  PMID: 40158524 BACKGROUND

MeSH Terms

Conditions

Chikungunya Fever

Condition Hierarchy (Ancestors)

Alphavirus Infections; Arbovirus Infections; Vector Borne Diseases; Infections; Mosquito-Borne Diseases; Virus Diseases; Togaviridae Infections; RNA Virus Infections

Study Officials

• Patrick Ajiboye, MD

  Bavarian Nordic A/S

  STUDY DIRECTOR

Central Study Contacts

Anjali Chudasama, MPH M.Sc.

CONTACT

844-422-8274; info@bavarian-nordic.com

Tiffany Brockington

CONTACT

info@bavarian-nordic.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be stratified by age group by age group (12 to \<18, 18 to 64, and ≥65 years old) and site, and randomized in a 1:1 ratio to receive either a single intramuscular (IM) dose of 40 µg CHIKV VLP vaccine or placebo at Day 1.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2); PH (1)