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Tests treatment safety and results for Chikungunya Virus
Official title A Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children.
ClinicalTrials.gov ID: NCT07003984
What this study is testing
What is CHIKV VLP vaccine?
CHIKV VLP vaccine is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for chikungunya virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 11. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Body weight ≥6.5 kg.
- In general good health, in the opinion of the investigator, based on medical history and physical examination.
- Able and willing to provide informed assent for study participation and primary caregiver is able and willing to provide informed consent for study...
- Able and willing to complete all scheduled visits and comply with all study procedures.
You likely can't join if
- Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of...
- Current acute illness, with or without fever.
- Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT)...
- History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
- History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
- Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 180 days prior to screening through Day 22. Note...
See the full eligibility criteria
- 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
- Body weight ≥6.5 kg.
- In general good health, in the opinion of the investigator, based on medical history and physical examination.
- 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...
- Able and willing to complete all scheduled visits and comply with all study procedures.
- 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...
- Current acute illness, with or without fever.
- 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...
- History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
- History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
- 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...
- Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
- 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.
- 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...
- Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating intramuscular vaccination, as judged by the investigator.
- Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
- Onset of menarche prior to study vaccination.
- Planned medical or surgical procedure that could adversely impact the participant's participation or the conduct of the study.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fountain Valley, California, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Omaha, Nebraska, United States
- Cincinnati, Ohio, United States
- Beaumont, Texas, United States
- West Jordan, Utah, United States
- Dasmariñas, Cavite, Philippines
- Imus, Cavite, Philippines
- Silang, Cavite, Philippines
- Las Piñas, National Capital Region, Philippines
- Manila, National Capital Region, Philippines
- Manila, Philippines
- San Juan, Puerto Rico, Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 11 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fountain Valley, California, United States; Washington D.C., District of Columbia, United States; Miami, Florida, United States; Omaha, Nebraska, United States; Cincinnati, Ohio, United States; Beaumont, Texas, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.