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Chikungunya VirusPhase 3NCT07467707

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

A Phase 3 study testing CHIKV VLP vaccine in people with Chikungunya Virus, run by Bavarian Nordic at 3 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Chikungunya Virus
What is being tested?
CHIKV VLP vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,144 participants
Where
3 sitesin 2 countries
Study dates
26 May 2026to May 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
  • History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product administration (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Notes: i) history of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured is not exclusionary; ii) history of malignancy considered cured from over 5 years from the date of screening with minimal risk of reoccurrence or relapse is not exclusionary; iii) documented controlled HIV infection (most recent tests show undetectable viral load and a CD4 cell count over 350 at the time of investigational product administration) is not exclusionary.
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  • Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and/or therapy with alkylating agents, antimetabolites, or radiation from 6 months prior to screening through Day 22 visit (21 days [-3/+5] after investigational product administration). Note: i) for systemic corticosteroid uses at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 visit is exclusionary, and ii) use of inhaled, intranasal, topical, or ocular steroids is not exclusionary.
  • 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.

Trial locations and contacts

3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Anjali Chudasama, MPH M.Sc. contact

844-422-8274

info@bavarian-nordic.com

Tiffany Brockington contact

info@bavarian-nordic.com

3 sites in 2 countries

Thailand2 sites, 2 recruiting
  • Songklanagarind hospital, Prince of Songkla University (PSU)

    Hat Yai, Changwat Songkhla, 90110

    Bavarian Nordic Investigative Site

    Not yet recruiting
  • Kamphaeng Phet Provincial Hospital

    Kamphaeng Phet, Changwat Kamphaeng Phet, 62000

    Bavarian Nordic Investigative Site

    Recruiting

Other trials in Thailand

Philippines1 site, 1 recruiting
  • WRAIR-AFRIMS Philippines, Cebu (WRAIR-APC)

    Cebu City, Cebu, 6000

    Bavarian Nordic Investigative Site

    Recruiting

Other trials in Philippines

About this study

Official title: 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)

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.

Being tested
CHIKV VLP vaccine, Placebo
Keywords
Chikungunya, PXVX0317, CHIKV VLP, vaccine, immunogenicity, efficacy, safety, VIMKUNYA, adolescents, adults
Medical subject headings
Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHIKV VLP vaccineBiological

    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.

  • PlaceboBiological

    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.

Study groups in NCT07467707
Study groupRoleWhat they receive
Arm 1: Cohort 1 Active GroupActive comparatorCHIKV VLP/adjuvant
Receives: Biological: CHIKV VLP vaccine
Arm 2: Cohort 1 Placebo GroupPlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (9)
  1. Incidence of laboratory-confirmed chronic CHIKV disease

    Laboratory-confirmed chronic CHIKV disease is defined as the persistence of at least one of the articular manifestations (continuous or recurrent pain, rigidity, edema) for >12 weeks after the onset of laboratory confirmed acute CHIKV disease.

    Measured: 98 days postvaccination through end of study follow-up, up to 1095 days postvaccination

  2. Incidence of laboratory-confirmed severe CHIKV disease.

    Laboratory-confirmed severe CHIKV disease is defined as a laboratory confirmed acute CHIKV disease presenting with dysfunction of at least one organ or system that threatens life and requires hospitalization.

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

  3. Number of participants with Solicited or Local Adverse Events

    In the Safety Subset, the number and percentage of participants with local and systemic reactogenicity events through 7 days postvaccination.

    Measured: Within 7 days postvaccination

  4. Number of participants with Unsolicited Adverse Events

    In the Safety Subset, the number and percentage of participants with unsolicited adverse events through 28 days postvaccination.

    Measured: Within 28 days postvaccination

  5. Number of Participants with Serious Adverse Events

    For all study participants who receive investigational product, number and percentage of participants with Serious Adverse Events (SAEs).

    Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.

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

  6. Number of Participants with Adverse Events of Special Interest

    Adverse events of special interest are defined as the occurrence of new onset or worsening arthralgia that is medically attended and are not associated with a febrile disease case. For all study participants who receive investigational product, number and percentage of participants with AESI for the duration of the study.

    Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.

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

  7. Number of Participants with Medically Attended Adverse Events

    Medically attended adverse events (MAAEs) are defined as adverse events requiring a visit to the hospital, emergency room, urgent care clinic, or other visits to or from medical personnel that are not part of routine scheduled study visits. For study participants in the Safety Subset, the number and percentage of participants with MAAEs for the duration of the study.

    Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.

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

  8. Anti-CHIKV Serum Neutralizing antibody titers

    Geometric Mean Titers (GMTs) of anti-CHIKV serum neutralizing antibodies based on a validated luciferase based anti-CHIKV neutralization assay.

    Measured: 3 weeks postvaccination

  9. Anti-CHIKV Serum Neutralizing Antibody seroresponse rate

    Seroresponse is defined as the presence of anti-CHIKV serum neutralizing antibody (SNA) titer meeting or exceeding 100. Seroresponse rate is defined as the percentage of participants with an Anti-CHIKV SNA titer meeting or exceeding a titer of 100 based on a validated luciferase based anti-CHIKV neutralization assay.

    Measured: 3 weeks postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study start26 May 2026
  3. Primary completionMay 2030 (estimated)
  4. Study completionMay 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07467707
Sponsor's protocol ID
EBSI-CV-317-007
Status last verified
Jun 2026
First submitted
9 Mar 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35709798
  • 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.

    PubMed 37690874
  • 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.

    PubMed 40158526
  • 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.

    PubMed 40158524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHIKV VLP vaccine in people with Chikungunya Virus, run by Bavarian Nordic at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anjali Chudasama, MPH M.Sc. (844-422-8274, info@bavarian-nordic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of laboratory-confirmed acute CHIKV disease (time frame: From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07467707, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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