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

NCT07003984 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: EBSI-CV-317-006
• Study Type: interventional
• Target: 720
• Locations: 3 countries
• Sites: 15

Brief Summary

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.

Conditions

Chikungunya Virus

Keywords

Chikungunya; PXVX0317; CHIKV VLP; vaccine; immunogenicity; VIMKUNYA; children

Outcome Measures

Primary Outcomes (3)

• Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs

  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

  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.

• Safety Endpoint 2: Incidence of unsolicited AEs through Day 29

  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.

Secondary Outcomes (11)

• Key Secondary Immunogenicity Endpoint 2: Day 22 anti-CHIKV SNA seroresponse rate in both seronegative and seropositive children

  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

  Study Day 15, 14 days after vaccination with CHIKV VLP vaccine or placebo.

• Safety Endpoint 1: 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 1: Day 15 anti-CHIKV SNA seroresponse rate in seronegative children

  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

  Study Day 183 and Day 366, 182 and 365 days after vaccination with CHIKV VLP vaccine or placebo, respectively.

Study Arms (4)

Arm 1

EXPERIMENTAL

Cohort 1 Active Group

Biological: CHIKV VLP vaccine

Arm 2

PLACEBO COMPARATOR

Cohort 1 Placebo Group

Biological: Placebo

Arm 3

EXPERIMENTAL

Cohort 2 Active Group

Biological: CHIKV VLP vaccine

Arm 4

PLACEBO COMPARATOR

Cohort 2 Placebo Group

Biological: Placebo

Interventions

CHIKV VLP vaccine BIOLOGICAL

CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%

Arm 1; Arm 3

Placebo BIOLOGICAL

Placebo is comprised of formulation buffer

Arm 2; Arm 4

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Body weight ≥6.5 kg.
• In general good health, in the opinion of the investigator, based on medical history and physical examination.
• 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.
• Able and willing to complete all scheduled visits and comply with all study procedures.

You may not qualify if:

• 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.
• Current acute illness, with or without fever.
• 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.
• History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
• History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
• Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
• 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.
• Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.
• Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
• Onset of menarche prior to study vaccination.
• Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.
• 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.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (15)

ARK Clinical Research, LLC

Fountain Valley, California, 92708, United States

RECRUITING

Emerson Clinical Research Institute- DC

Washington D.C., District of Columbia, 20009, United States

RECRUITING

Acevedo Clinical Research

Miami, Florida, 33142, United States

RECRUITING

Hope Research Network

Miami, Florida, 33166, United States

RECRUITING

Velocity Clinical Research-Omaha

Omaha, Nebraska, 68134, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

KidCare Pediatrics

Beaumont, Texas, 77706, United States

RECRUITING

Velocity Clinical Research - Salt Lake City

West Jordan, Utah, 84088, United States

RECRUITING

CARE CT Group Inc.

Dasmariñas, Cavite, 4114, Philippines

RECRUITING

HIMC Research and Development on Medical Sciences

Imus, Cavite, 4103, Philippines

RECRUITING

Silang Specialist Medical Center

Silang, Cavite, 4118, Philippines

RECRUITING

University of Perpetual Help DALTA Medical Center, Biomedical Research Institute

Las Piñas, National Capital Region, 1740, Philippines

NOT YET RECRUITING

Institute of Child Health and Human Development, University of the Philippines

Manila, National Capital Region, 1000, Philippines

RECRUITING

University of the Philippines-Philippine General Hospital

Manila, 100, Philippines

NOT YET RECRUITING

CMRC Headlands LLC

San Juan, Puerto Rico, 918, Puerto Rico

RECRUITING

Related Publications (3)

• 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

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

Priya Uppin

CONTACT

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

Faye Cross

CONTACT

info@bavarian-nordic.com

Study Design

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

Model Details: Participants will be stratified by site and age subgroup, 6 to \<12 years of age (Cohort 1) and 1 to \<6 years of age (Cohort 2), and randomized in a 4:1 ratio to receive either a single intramuscular (IM) dose of 40 µg CHIKV VLP vaccine or placebo at Day 1. Using the same strata, participants will be randomized in a 1:1 ratio to attend Visit 2 at either Day 15 or Day 22.

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 4, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PH (6); US (8); PR (1)