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CHIKV VLP Vaccine Study in Children

This study is testing a vaccine called CHIKV VLP vaccine to see if it's safe and if it helps children's bodies fight off the Chikungunya virus. The vaccine uses "virus-like particles" (VLPs), which are tiny parts of the virus that can't cause illness but can teach the body to protect itself. Some children will receive the CHIKV VLP vaccine, while others will receive a placebo (a substance with no active medicine). We are looking for children between 1 and 11 years old who are generally healthy and weigh at least 6.5 kg. The study will measure how safe the vaccine is by tracking any side effects and how well it helps the body create a protective response against the virus. The study plans to enroll 720 children.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the vaccine or placebo, and neither you nor the study team will know which you receive. It plans to enroll 720 children.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety through the end of the trial, planned to be Day 732 (about 2 years) for those who complete the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07003984

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

Recruiting
PHASE3Ages 1–11InterventionalPrevention
Bavarian Nordic
~720 participants
Updated 2026-03-24 on ClinicalTrials.gov
What's tested:CHIKV VLP vaccinePlacebo

At a glance

Recruiting sites
13 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEs
Measured over From vaccination through the end of the trial, planned to be Day 732 for study completers.
+2 more outcomes measured

Conditions

Chikungunya Virus

Explore related trials

Chikungunya

NCT07003984

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Acevedo Clinical Research

    Miami, Floridastudy coordinator listed

    Recruiting

  • ARK Clinical Research, LLC

    Fountain Valley, Californiastudy coordinator listed

    Recruiting

  • CARE CT Group Inc.

    Dasmariñas, Cavite, Philippinesstudy coordinator listed

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • CMRC Headlands LLC

    San Juan, Puerto Rico, Puerto Ricostudy coordinator listed

    Recruiting

  • Emerson Clinical Research Institute- DC

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • HIMC Research and Development on Medical Sciences

    Imus, Cavite, Philippinesstudy coordinator listed

    Recruiting

  • Hope Research Network

    Miami, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Patrick Ajiboye, MD · STUDY_DIRECTOR · Bavarian Nordic A/S

Who to contact

Priya Uppin
[email protected]
844-422-8274
Email the study team

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Safety Endpoint 3: Incidence of AESI, MAAEs, and SAEsFrom 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.

  • Primary Immunogenicity Endpoint: Day 22 anti-CHIKV SNA seroresponse rate in seronegative childrenStudy 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.

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