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Prevention study for Chikungunya Virus
Official title An Efficacy, Safety, and Immunogenicity Study of CHIKV VLP Vaccine for the Prevention of Chikungunya Disease in Adolescents and Adults
ClinicalTrials.gov ID: NCT07467707
What this study is testing
What is CHIKV VLP vaccine?
CHIKV VLP vaccine is an investigational medicine, given as an injection into a muscle, 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
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older. Healthy volunteers may be eligible.
You may be able to join if
- Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must...
- 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...
- Women who are either:
- Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or...
You likely can't join if
- Currently pregnant or breastfeeding.
- Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for...
- 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 treatment CHIKV trial/study.
- Prior documented, laboratory confirmed CHIKV disease.
- History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product...
See the full eligibility 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...
- 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...
- Meeting all the below criteria:
- Negative urine pregnancy test at screening visit
- Negative urine pregnancy test immediately prior to dosing
- Using an acceptable form of contraception per local standards and agree to use this for at least 8 weeks after investigational product administration Note: Contraception requirements do not apply for participants in...
- Currently pregnant or breastfeeding.
- 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...
- 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 treatment CHIKV trial/study.
- Prior documented, laboratory confirmed CHIKV disease.
- 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...
- Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and/or therapy with alkylating...
- Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit.
- Unstable medical condition in the last 30 days prior to Day 1.
- Acute illness with or without fever (oral temperatures ≥38.0 ºC [100.4 °F]) within 14 days prior to investigational product administration.
- Medical or social condition (eg, substance abuse) that could have an impact on the participant's ability to be compliant with study procedures/visits, as determined by the investigator.
- Plans to travel outside the study area or move away for more than 3 consecutive months and will not be available for follow up at the site.
- Identified as an investigator or employee of an investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or...
- Any other medical condition that, in the opinion of the investigator, could adversely impact the participant's participation or the conduct of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Cebu City, Cebu, Philippines
- Kamphaeng Phet, Changwat Kamphaeng Phet, Thailand
- Hat Yai, Changwat Songkhla, Thailand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 12 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cebu City, Cebu, Philippines; Kamphaeng Phet, Changwat Kamphaeng Phet, Thailand; Hat Yai, Changwat Songkhla, Thailand. 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.