A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.

March 20, 2026 updated by: Bavarian Nordic

A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 1 to <12 Years of Age

The goal of this multi-center, randomized, double-blind, placebo-controlled study is to evaluate the safety and immunogenicity of CHIKV VLP Vaccine in children 1 to <12 years of age.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
720

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Philippines
      • Manila, Philippines, 100
        • Not yet recruiting
        • University of the Philippines-Philippine General Hospital
        • Contact:
        • Principal Investigator:
          • Maria E Uy, MD
    • Cavite
      • Dasmariñas, Cavite, Philippines, 4114
        • Recruiting
        • CARE CT Group Inc.
        • Contact:
        • Principal Investigator:
          • Delia C Yu, MD
      • Imus, Cavite, Philippines, 4103
        • Recruiting
        • HIMC Research and Development on Medical Sciences
        • Contact:
        • Principal Investigator:
          • Edison Alberto, MD
      • Silang, Cavite, Philippines, 4118
        • Recruiting
        • Silang Specialist Medical Center
        • Contact:
        • Principal Investigator:
          • Maria T Gler, MD
    • National Capital Region
      • Las Piñas, National Capital Region, Philippines, 1740
        • Not yet recruiting
        • University of Perpetual Help DALTA Medical Center, Biomedical Research Institute
        • Contact:
        • Principal Investigator:
          • Mitzi C Trinidad-Aseron, MD
      • Manila, National Capital Region, Philippines, 1000
        • Recruiting
        • Institute of Child Health and Human Development, University of the Philippines
        • Contact:
        • Principal Investigator:
          • Michelle C Ylade, MD
  • Puerto Rico
    • Puerto Rico
      • San Juan, Puerto Rico, Puerto Rico, 918
        • Recruiting
        • CMRC Headlands LLC
        • Principal Investigator:
          • Carmen Deseda, MD
        • Contact:
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Ark Clinical Research, LLC
        • Principal Investigator:
          • Justin Yanuck
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20009
        • Recruiting
        • Emerson Clinical Research Institute- DC
        • Contact:
        • Principal Investigator:
          • Julie Pineda, MD
    • Florida
      • Miami, Florida, United States, 33142
      • Miami, Florida, United States, 33166
        • Recruiting
        • Hope Research Network
        • Contact:
        • Principal Investigator:
          • Mario Reyes, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Recruiting
        • Velocity Clinical Research-Omaha
        • Contact:
        • Principal Investigator:
          • Frederick Raiser, DO
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Robert Frenck, MD
    • Texas
      • Beaumont, Texas, United States, 77706
        • Recruiting
        • KidCare Pediatrics
        • Contact:
        • Principal Investigator:
          • Robert Codey Bell, MD
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Velocity Clinical Research - Salt Lake City
        • Principal Investigator:
          • Barbara Rizzardi, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Males or females between 1 and <12 years of age at Day 1 (day of vaccination). Note: Screening should only occur in the active/open cohorts. Please see Section 6.1 for details
  2. Body weight ≥6.5 kg.
  3. In general good health, in the opinion of the investigator, based on medical history and physical examination.
  4. Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
  5. Able and willing to complete all scheduled visits and comply with all study procedures.

Exclusion Criteria:

  1. Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; these instances should be discussed with the sponsor's medical monitor and written agreement obtained prior to enrollment.
  2. Current acute illness, with or without fever.
  3. Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
  4. History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
  5. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
  6. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg/kg for children <40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
  7. Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.

  8. Any administration or planned administration of:

    • A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
    • Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
    • Another licensed or investigational CHIKV vaccine.
  9. Known infection with human immunodeficiency virus, hepatitis C virus (HCV), or hepatitis B virus. Note: Positive anti-HCV antibodies and negative HCV polymerase chain reaction would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol.
  10. Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.
  11. Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
  12. Onset of menarche prior to study vaccination.
  13. Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.
  14. Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.
  15. Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant's participation or conduct of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
Cohort 1 Active Group
Biological: CHIKV VLP vaccine
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Placebo Comparator: Arm 2
Cohort 1 Placebo Group
Biological: Placebo
Placebo is comprised of formulation buffer
Experimental: Arm 3
Cohort 2 Active Group
Biological: CHIKV VLP vaccine
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Placebo Comparator: Arm 4
Cohort 2 Placebo Group
Biological: Placebo
Placebo is comprised of formulation buffer

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint 2: Incidence of unsolicited AEs through Day 29
Time Frame: From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.
Incidence of unsolicited adverse events (AEs) through Day 29.
From vaccination on Day 1 through Day 29, 28 days after vaccination with CHIKV VLP vaccine or placebo.
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
Time Frame: From vaccination through the end of the trial, planned to be Day 732 for study completers.
Incidence of adverse events of special interest (AESIs; defined as new onset or worsening arthralgia that is medically attended), medically attended adverse events (MAAEs), and serious adverse events (SAEs) through end of the trial.
From vaccination through the end of the trial, planned to be Day 732 for study completers.
Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative children
Time Frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population.
Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint 1: Incidence of solicited adverse events through Day 8
Time Frame: From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.
Incidence of solicited adverse events through Day 8.
From vaccination on study Day 1 through Day 8, 7 days after vaccination with CHIKV VLP vaccine or placebo.
Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time Frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population.
Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time Frame: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population.
Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Key Secondary Immunogenicity Endpoint 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children
Time Frame: Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Day 15 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population.
Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.
Secondary Immunogenicity Endpoint 2: Day 183 and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time Frame: Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Day 183 and Day 366 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population.
Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Secondary Immunogenicity Endpoint 3: Day 15, Day 22, Day 183, and Day 366 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children
Time Frame: Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Day 15, Day 22, Day 183, and Day 366 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in both baseline seronegative and seropositive children 1 to <12 years of age in the immunogenicity evaluable population, stratified by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Day 15, Day 22, Day 183, and Day 366, 14, 21, 182, and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.
Secondary Immunogenicity Endpoint 4: GMTs of anti-CHIKV SNA at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only
Time Frame: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Geometric mean titers (GMTs) of anti-CHIKV serum neutralizing antibodies (SNA) at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only, in children 1 to <12 years of age in the immunogenicity evaluable population by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 5a: GMFIs from Day 1 to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only
Time Frame: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Geometric mean fold increases (GMFIs) from Day 1 (prevaccination) to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only in children 1 to <12 years of age in the IEP and by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 5b: Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only
Time Frame: Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only in children 1 to <12 years of age in the IEP and by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Day 15, Day 22, Day 183, Day 366, and Day 732, 14, 21, 182, 365, and 731 days after vaccination, respectively.
Secondary Immunogenicity Endpoint 6: Anti-CHIKV SNA seroresponse rates at Day 732 in the CHIKV VLP vaccine group only
Time Frame: Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.
For the CHIKV VLP vaccine group only, anti-CHIKV serum neutralizing antibody (SNA) seroresponse rates at Day 732 in both baseline seronegative and seropositive children 1 to <12 years of age and by age stratum (1 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
Study Day 732, 731 days after vaccination with CHIKV VLP vaccine.
Secondary Immunogenicity Endpoint 7: Day 22 anti-CHIKV SNA seroresponse rate between seronegative children in the IEP versus adolescents and adults study EBSI-CV-317-004
Time Frame: Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.
Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate between baseline seronegative children 1 to <12 years of age in the immunogenicity evaluable population (IEP) versus adolescents and adults from 12 to <65 years of age in study EBSI-CV-317-004.
Study Day 22, 21 days after vaccination with CHIKV VLP vaccine or placebo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bavarian Nordic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Patrick Ajiboye, MD, Bavarian Nordic A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBSI-CV-317-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings