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.
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.
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
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 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.
Bavarian Nordic
Lead sponsor
Walter Reed Army Institute of Research (WRAIR)
Collaborator
Congressionally Directed Medical Research Programs
Collaborator
United States Department of Defense
Collaborator
Pharmaceutical Product Development, (PPD) LLC
Collaborator
Armed Forces Research Institute of Medical Services
Collaborator
Q-square Business Intelligence, Inc.
Collaborator