CHIKV VLP vaccine for children 1 to under 12 years

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

This test checks whether the CHIKV VLP vaccine is safe and produces an immune response in children aged 1 to under 12.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Ages: 1 Year to 11 Years
• Sex: All
• Sponsor: Bavarian Nordic (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 15 sites (Fountain Valley, California and 14 other locations)
• Trial ID: NCT07003984 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, double-blind, placebo-controlled Phase 3 trial gives children either the CHIKV VLP vaccine or a placebo and follows them for safety and antibody responses. Eligible participants are between 1 and under 12 years old, weigh at least 6.5 kg, and are generally in good health as determined by the investigator. Caregivers must provide informed consent and children must provide assent when appropriate, and participants must be able to complete scheduled visits. The study is conducted at several U.S. clinical research sites.

Who should consider this trial

Good fit: Children aged 1 to under 12 years who weigh ≥6.5 kg, are generally healthy, and whose caregiver can provide informed consent and commit to all study visits are ideal candidates.

Not a fit: Children who are participating in or plan to join another investigational clinical study within 30 days before vaccination or who are judged not in general good health by the investigator are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the vaccine could protect children from chikungunya by inducing protective immunity and reducing disease.

How similar studies have performed: VLP-based chikungunya vaccines have produced immune responses in early-phase adult trials, but well-established pediatric data are limited.

Eligibility criteria

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.

Where this trial is running

Fountain Valley, California and 14 other locations

• ARK Clinical Research, LLC — Fountain Valley, California, United States (Recruiting)
• Emerson Clinical Research Institute- DC — Washington D.C., District of Columbia, United States (Recruiting)
• Acevedo Clinical Research — Miami, Florida, United States (Recruiting)
• Hope Research Network — Miami, Florida, United States (Recruiting)
• Velocity Clinical Research-Omaha — Omaha, Nebraska, United States (Recruiting)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (Recruiting)
• KidCare Pediatrics — Beaumont, Texas, United States (Recruiting)
• Velocity Clinical Research - Salt Lake City — West Jordan, Utah, United States (Recruiting)
• CARE CT Group Inc. — Dasmariñas, Cavite, Philippines (Recruiting)
• HIMC Research and Development on Medical Sciences — Imus, Cavite, Philippines (Recruiting)
• Silang Specialist Medical Center — Silang, Cavite, Philippines (Recruiting)
• University of Perpetual Help DALTA Medical Center, Biomedical Research Institute — Las Piñas, National Capital Region, Philippines (Not_yet_recruiting)
• Institute of Child Health and Human Development, University of the Philippines — Manila, National Capital Region, Philippines (Recruiting)
• University of the Philippines-Philippine General Hospital — Manila, Philippines (Not_yet_recruiting)
• CMRC Headlands LLC — San Juan, Puerto Rico, Puerto Rico (Recruiting)

Study contacts

• Study coordinator: Priya Uppin

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