Study EBSI-CV-317-007 is a field study to evaluate the efficacy, immunogenicity, and safety of CHIKV VLP vaccine. The study was designed using infectious disease models and advanced analytics to guide region and clinical site prioritization, define the timing of study activities, and optimize the study parameters to local epidemiological conditions for CHIKV disease to overcome the challenges of assessing efficacy for CHIKV VLP vaccine.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must verbalize understanding of the reason for and the procedures needed for the study and be willing to stay in the study for its entire duration.
. Male or nonpregnant female 12 years of age and older.
. In stable health per the investigator, and no hospital admission or major surgical procedure in the last 30 days before investigational product administration.
. Women who are either:
. Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment). or
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of laboratory-confirmed acute CHIKV disease
Timeframe: From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
. Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for the duration of the study. Note: Participation in an observational trial/study or follow-up phase of a trial/study may be eligible; however, participation in any other study should be discussed with the MM prior to enrollment.
. History of severe allergic reaction or anaphylaxis to any component of the investigational product.
. Prior receipt of any CHIKV vaccine (or therapeutic) or participation in a prior interventional CHIKV trial/study.
. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product administration (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Notes: i) history of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured is not exclusionary; ii) history of malignancy considered cured from over 5 years from the date of screening with minimal risk of reoccurrence or relapse is not exclusionary; iii) documented controlled HIV infection (most recent tests show undetectable viral load and a CD4 cell count over 350 at the time of investigational product administration) is not exclusionary.
. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and/or therapy with alkylating agents, antimetabolites, or radiation from 6 months prior to screening through Day 22 visit (21 days \[-3/+5\] after investigational product administration). Note: i) for systemic corticosteroid uses at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 visit is exclusionary, and ii) use of inhaled, intranasal, topical, or ocular steroids is not exclusionary.
. Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit.