Chikungunya Virus Vaccine Trial in Healthy Adults

INCLUSION CRITERIA

A participant must meet all of the following criteria:

• 18 to 50 years old
• Available for clinical follow-up through Week 44
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly
• Able and willing to complete the informed consent process
• Willing to donate blood for sample storage to be used for future research
• In good general health, with a BMI less than or equal to 40, without clinically significant medical history, and has satisfactorily completed screening
• Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment

Laboratory Criteria within 56 days prior to enrollment:

• Hemoglobin greater than or equal to11.5 g/dL for women; greater than or equal to13.5 g/dL for men
• WBC: 3,000-12,000 cells/mm(3).
• Differential either within institutional normal range or accompanied by physician approval
• Total lymphocyte count: greater than or equal to 800 cells/mm(3)
• Platelets = 125,000-500,000/mm(3)
• Alanine aminotransferase (ALT) less than or equal to 1.25 times upper limit of normal range
• Serum creatinine less than or equal to1x upper limit of normal (less than or equal to1.3 mg/dL for females; less than or equal to1.4 mg/dL for males).
• Negative FDA-approved HIV blood test

Female-Specific Criteria

• Negative Beta-HCG pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential
• A woman of childbearing potential must agree to use an effective means of birth control from at least 21 days prior to enrollment through 12 weeks after last study vaccination

EXCLUSION CRITERIA

A participant will be excluded if one or more of the following conditions apply:

Female-Specific Criteria

• Woman who is breast-feeding or planning to become pregnant during the time projected for individual study participation
• Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior to enrollment [with the exceptions that a short course of corticosteroids (less than or equal to10 days duration or a single injection) for a self-limited condition at least 2 weeks prior to enrollment will not exclude study participation]
• Blood products within 16 weeks prior to enrollment
• Immunoglobulin within 8 weeks prior to enrollment
• Prior vaccinations with an investigational CHIKV vaccine
• Investigational research agents within 4 weeks prior to enrollment
• Live attenuated vaccines within 4 weeks prior to enrollment
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 2 weeks prior to enrollment
• Current anti-TB prophylaxis or therapy

Subject has a history of any of the following clinically significant conditions:

• A history of confirmed or suspected CHIKV infection
• A history of immune-mediated or clinically significant arthritis
• Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator
• Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that is expected to require the use of oral or intravenous corticosteroids
• Diabetes mellitus (type I or II), with the exception of gestational diabetes
• Idiopathic urticaria within the past year
• Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
• Malignancy that is active, or treated malignancy for which there is not reasonable assurance of sustained cure, or mal