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.
Parallel
CHIKV VLP vaccine
Biological/VaccineCHIKV VLP vaccine is comprised of 40 µg CHIKV VLP adsorbed on aluminum hydroxide (corresponding to approximately 300 µg of aluminum and stabilized with formulation buffer). CHIKV VLP vaccine is supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
Placebo
Biological/VaccinePlacebo is comprised of formulation buffer supplied as a single dose of 0.8 mL in a single use pre-filled syringe administered via IM injection in the deltoid muscle.
Incidence of laboratory-confirmed acute CHIKV disease
Laboratory-confirmed acute CHIKV disease is defined by the presence of fever, one or more of arthralgia, myalgia or rash, and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) confirmation of CHIKV ribonucleic acid.
Incidence of laboratory-confirmed chronic CHIKV disease
Laboratory-confirmed chronic CHIKV disease is defined as the persistence of at least one of the articular manifestations (continuous or recurrent pain, rigidity, edema) for \>12 weeks after the onset of laboratory confirmed acute CHIKV disease.
Incidence of laboratory-confirmed severe CHIKV disease.
Laboratory-confirmed severe CHIKV disease is defined as a laboratory confirmed acute CHIKV disease presenting with dysfunction of at least one organ or system that threatens life and requires hospitalization.
Number of participants with Solicited or Local Adverse Events
In the Safety Subset, the number and percentage of participants with local and systemic reactogenicity events through 7 days postvaccination.
Number of participants with Unsolicited Adverse Events
In the Safety Subset, the number and percentage of participants with unsolicited adverse events through 28 days postvaccination.
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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
