A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults

Exclusion Criteria

• •1. Participants with past or current ZIKV infection by self-report.
• •2. Participants with past or current dengue virus, yellow fever virus, Japanese encephalitis virus, tick-borne encephalitis virus or West Nile virus infection by self-report.
• •Participants who have travelled to dengue and/or Zika endemic countries and US regions and territories\*, or who plan to travel to these countries/regions within 1 month prior to anticipated enrollment up to 1 month post dose 2.
• •\*Centers for Disease Control and Prevention (CDC) website describes dengue/Zika endemic countries and US regions and territories.
• •3. Participants with any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barré syndrome).
• •4. Participants with known or suspected impairment/alteration of immune function, including:
• •1. Chronic use of oral or parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks / ≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
• •2. Receipt of immunomodulatory agents within 60 days prior to Day 1.
• •3. Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derived products within 3 months prior to Day 1 or planned receipt during the full length of the trial. In addition, participants must be advised not to donate blood during the study period.
• •4. Known Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
• •5. Genetic immunodeficiency.
• •5. Participants with known current or chronic hepatitis B and/or hepatitis C infections.
• •6. Participants with abnormalities of splenic or thymic function.
• •7. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
• •8. Participants with any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, insulin-dependent diabetes, cardiac, renal, hepatic or thyroid disease, uncontrolled hypertension, uncontrolled asthma).
• •9. Participants with a history of substance or alcohol abuse within the past 2 years.