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New vaccine trial aims to protect kids from mosquito virus

NCT ID NCT07003984

Vaccine Sponsor: Bavarian Nordic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a vaccine against chikungunya virus in about 720 children aged 1 to under 12. The vaccine uses virus-like particles to train the immune system. Researchers will check if it is safe and triggers a strong immune response compared to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 720 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 11 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chikungunya prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chikungunya virus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites in 3 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • ARK Clinical Research, LLC

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Acevedo Clinical Research

    RECRUITING

    Miami, Florida, 33142, United States

  • CARE CT Group Inc.

    RECRUITING

    Dasmariñas, Cavite, 4114, Philippines

  • CMRC Headlands LLC

    RECRUITING

    San Juan, Puerto Rico, 918, Puerto Rico

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Emerson Clinical Research Institute- DC

    RECRUITING

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

  • HIMC Research and Development on Medical Sciences

    RECRUITING

    Imus, Cavite, 4103, Philippines

  • Hope Research Network

    RECRUITING

    Miami, Florida, 33166, United States

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

    RECRUITING

    Manila, National Capital Region, 1000, Philippines

  • KidCare Pediatrics

    RECRUITING

    Beaumont, Texas, 77706, United States

  • Silang Specialist Medical Center

    RECRUITING

    Silang, Cavite, 4118, Philippines

    Contact Email: •••••@•••••

  • University of Perpetual Help DALTA Medical Center, Biomedical Research Institute

    NOT_YET_RECRUITING

    Las Piñas, National Capital Region, 1740, Philippines

  • University of the Philippines-Philippine General Hospital

    NOT_YET_RECRUITING

    Manila, 100, Philippines

  • Velocity Clinical Research - Salt Lake City

    RECRUITING

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research-Omaha

    RECRUITING

    Omaha, Nebraska, 68134, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.