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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
6,144
CHIKV 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 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.
WRAIR-AFRIMS Philippines, Cebu (WRAIR-APC)
Cebu City, Cebu, Philippines
Kamphaeng Phet Provincial Hospital
Kamphaeng Phet, Changwat Kamphaeng Phet, Thailand
Songklanagarind hospital, Prince of Songkla University (PSU)
Hat Yai, Changwat Songkhla, Thailand
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.
Time frame: From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
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.
Time frame: 98 days postvaccination through end of study follow-up, up to 1095 days postvaccination
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.
Time frame: 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
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.
Time frame: Within 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.
Time frame: Within 28 days postvaccination
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Number of Participants with Serious Adverse Events
For all study participants who receive investigational product, number and percentage of participants with Serious Adverse Events (SAEs). Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.
Time frame: Through end of study follow-up, up to 1095 days postvaccination
Number of Participants with Adverse Events of Special Interest
Adverse events of special interest are defined as the occurrence of new onset or worsening arthralgia that is medically attended and are not associated with a febrile disease case. For all study participants who receive investigational product, number and percentage of participants with AESI for the duration of the study. Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.
Time frame: Through end of study follow-up, up to 1095 days postvaccination
Number of Participants with Medically Attended Adverse Events
Medically attended adverse events (MAAEs) are defined as adverse events requiring a visit to the hospital, emergency room, urgent care clinic, or other visits to or from medical personnel that are not part of routine scheduled study visits. For study participants in the Safety Subset, the number and percentage of participants with MAAEs for the duration of the study. Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.
Time frame: Through end of study follow-up, up to 1095 days postvaccination
Anti-CHIKV Serum Neutralizing antibody titers
Geometric Mean Titers (GMTs) of anti-CHIKV serum neutralizing antibodies based on a validated luciferase based anti-CHIKV neutralization assay.
Time frame: 3 weeks postvaccination
Anti-CHIKV Serum Neutralizing Antibody seroresponse rate
Seroresponse is defined as the presence of anti-CHIKV serum neutralizing antibody (SNA) titer meeting or exceeding 100. Seroresponse rate is defined as the percentage of participants with an Anti-CHIKV SNA titer meeting or exceeding a titer of 100 based on a validated luciferase based anti-CHIKV neutralization assay.
Time frame: 3 weeks postvaccination