Safety Study of Hepatitis E Vaccine (HEV239)

Exclusion Criteria

• •1. Has a previous HEV infection or chronic liver disease.
• •2. Has received any experimental agent\* within 30 days prior to first vaccination, or the expected recipient of any experimental agent during this trial-reporting period.
• •\*Including vaccines, drugs, biologics, devices, and/or blood products.
• •3. Female subject is pregnant (or has a positive pregnancy test prior to vaccination) or breast feeding, or planning to become pregnant within 3 months after the last boost vaccination.
• •4. Fever (\> / = 38.0 Degrees Celsius / 100.4 Degrees Fahrenheit) or other acute illness within 3 days prior to first vaccination.
• •5. Infection requiring systemic antibiotics or antiviral treatment within the 7 days prior to first vaccination.
• •6. Has a positive urine drug screen for amphetamines\*, cocaine, opiates, or phencyclidine.
• •\*Prescription amphetamines are not exclusionary.
• •7. Chronic, clinically significant medical or psychiatric conditions\* that, in the opinion of the investigator, may pose additional risk to the subject if she/he participates in the study.
• •\*Permissible conditions include but are not limited to mild, well-controlled asthma, well-controlled depression, well-controlled anxiety, seasonal allergies, and well-controlled hypertension.
• •8. Receipt of immunosuppressive drugs\*,\*\*,\*\*\* or biologic agents within the 30 days prior to enrollment.
• •\*This includes use of oral or parental prednisone. This also includes allergy desensitization injections from 14 days prior to each vaccination through 14 days after each vaccination. The use of topical steroids for mild uncomplicated dermatitis permissible after therapy is completed. Over-the-counter (OTC) corticosteroid nasal sprays for allergic rhinitis are permissible. The use of low or moderate dose inhaled steroids is permissible. Doses are defined as per age as using inhaled high-dose per reference chart in the National Heart, Lung and Blood Institute Guidelines for the Diagnosis and Management of Asthma (EPR-3) or other lists published in UPTODATE.
• •\*\*Receipt of systemic, prescription medications for the treatment of chronic medical conditions or variations of normal physiologic functions may be permissible if, in the opinion of the investigator, they are used for conditions that are not clinically significant and would not impact the safety of the subject or the safety and immunogenicity outcomes of the protocol.
• •\*\*\*Use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity.
• •9. Has known neoplastic disease\* anticancer therapy, or radiation therapy within 3 years prior to first study vaccination.
• •\*Excluding non-melanoma skin cancer, such as squamous cell skin cancer or basal cell skin cancer, cured by surgical excision.
• •10. Has a history of any hematologic malignancy at any time.
• •11. Has a known or suspected congenital or acquired disease that impairs the immune system, including functional asplenia or immunosuppression as a result of underlying illness or treatment.
• •12. Has prior organ and/or stem cell transplant.
• •13. Has a history of abuse of alcohol or drugs that, in the opinion of the investigator, may interfere with the subject's ability to comply with the protocol.
• •14. Has behavioral or cognitive impairment or psychiatric conditions that, in the opinion of the investigator, may interfere with the subject's ability to participate in the trial.
• •15. Has received blood products or immunoglobulin within six months prior to vaccination.
• •16. Travel to Asia, the Middle East, Africa, or Central America or to an area with an active Hepatitis E outbreak\* within the last 90 days or intention to travel to such areas during the study.
• •\*Outbreaks within the last 3 years.
• •17. Receipt of any inactivated vaccine from 2 weeks prior to each vaccination through 2 weeks after each vaccination.
• •18. Receipt of any live vaccine from 4 weeks prior to each vaccination through 4 weeks after each vaccination.
• •19. Known hypersensitivity or allergy to aluminum, any component of the vaccine, or other serious adverse reactions to vaccines or vaccine products.
• •20. Subject who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study.
• •21. Any condition that, in the opinion of the investigator, might interfere with assessing the study objectives.