A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
NCT ID: NCT07003984
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
720 participants
INTERVENTIONAL
2025-06-05
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Arm 1
Cohort 1 Active Group
CHIKV VLP vaccine
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Arm 2
Cohort 1 Placebo Group
Placebo
Placebo is comprised of formulation buffer
Arm 3
Cohort 2 Active Group
CHIKV VLP vaccine
CHIKV VLP vaccine is comprised of chikungunya virus virus-like particles (CHIKV VLP), adsorbed on aluminum hydroxide (Alhydrogel®) adjuvant 2%
Arm 4
Cohort 2 Placebo Group
Placebo
Placebo is comprised of formulation buffer
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. In general good health, in the opinion of the investigator, based on medical history and physical examination.
3. 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.
4. Able and willing to complete all scheduled visits and comply with all study procedures.
Exclusion Criteria
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.
2 Years
11 Years
ALL
Yes
Sponsors
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Bavarian Nordic
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick Ajiboye, MD
Role: STUDY_DIRECTOR
Bavarian Nordic A/S
Locations
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ARK Clinical Research, LLC
Fountain Valley, California, United States
Emerson Clinical Research Institute- DC
Washington D.C., District of Columbia, United States
Acevedo Clinical Research
Miami, Florida, United States
Hope Research Network
Miami, Florida, United States
Velocity Clinical Research-Omaha
Omaha, Nebraska, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
KidCare Pediatrics
Beaumont, Texas, United States
Velocity Clinical Research - Salt Lake City
West Jordan, Utah, United States
Caribbean Medicine Center
San Juan, Puerto Rico, Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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EBSI-CV-317-006
Identifier Type: -
Identifier Source: org_study_id
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