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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

720

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Bavarian Nordic

Investigators

  • 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)

June 5, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

May 27, 2025

First Submitted That Met QC Criteria

May 27, 2025

First Posted (Actual)

June 4, 2025

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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