Recruiting
Phase 3

CHIKV VLP Vaccine

Sponsor:

Bavarian Nordic

Code:

NCT07003984

Conditions

Chikungunya Virus

Eligibility Criteria

Sex: All

Age: 1 - 11

Healthy Volunteers: Accepted

Interventions

CHIKV VLP vaccine

Placebo

Study Details

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

Study ID

NCT07003984

Start date

Jun 5, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 11

Healthy Volunteers: Accepted

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 Design

Enrollment

720 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Arm 1

Cohort 1 Active Group

placebo comparator: Arm 2

Cohort 1 Placebo Group

experimental: Arm 3

Cohort 2 Active Group

placebo comparator: Arm 4

Cohort 2 Placebo Group

Interventions

CHIKV VLP vaccine

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

Placebo

Placebo is comprised of formulation buffer

Primary outcome measure

  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Locations

ARK Clinical Research, LLC

Recruiting

Fountain Valley, California, United States, 92708

Contacts

Principal Investigator:

Justin Yanuck

Emerson Clinical Research Institute- DC

Recruiting

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

Contacts

Principal Investigator:

Julie Pineda, MD

Acevedo Clinical Research

Recruiting

Miami, Florida, United States, 33142

Contacts

Principal Investigator:

Giselle Deiros, MD

Hope Research Network

Recruiting

Miami, Florida, United States, 33166

Contacts

Principal Investigator:

Mario Reyes, MD

Velocity Clinical Research-Omaha

Recruiting

Omaha, Nebraska, United States, 68134

Contacts

Principal Investigator:

Frederick Raiser, DO

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Principal Investigator:

Robert Frenck, MD

KidCare Pediatrics

Recruiting

Beaumont, Texas, United States, 77706

Contacts

Principal Investigator:

Robert Codey Bell, MD

Velocity Clinical Research - Salt Lake City

Recruiting

West Jordan, Utah, United States, 84088

Contacts

Principal Investigator:

Barbara Rizzardi, MD

More Information

Sponsor

Bavarian Nordic

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bavarian Nordic on 2026-03-24.