Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines (HTNV/PUUV)

This is an interventional prevention trial for Hemorrhagic Fever With Renal Syndrome focused on measuring HFRS Read More

Inclusion Criteria:

• Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at time of screening

• Have demonstrated adequate comprehension of the protocol, by achieving a score of at least 80% correct on a short multiple-choice quiz

  • Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of protocol information
  • Individuals who fail the comprehension assessment for the second time will not be enrolled
• Have provided written informed consent before screening
• Free of clinically significant health problems, as determined by pertinent medical history and clinical examination before entry into the study
• Available and able to participate for all study visits and procedures
• If sexually active, known to be at least 1 year post-menopausal, or willing to use an effective method of contraception (e.g., birth control pill, diaphragm, cervical cap, intrauterine device, condom, or anatomical sterility [in self or partner]) from the date of screening until at least 6 months after the last vaccination
• Negative hantavirus IgG antibody test result at screening (ELISA)

Exclusion Criteria:

• History or serologic evidence of prior infection with either HTNV or PUUV virus, or prior participation in a HTNV or PUUV virus vaccine trial
• History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
• Any serologic evidence of hepatitis B or C infection
• Ongoing participation in another clinical trial
• Receipt or planned receipt of any vaccination, experimental or otherwise, within the period 30 days prior to initial injection through 60 days after the Day 70 follow-up (approximately a 6 month period in total)
• Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid region) exceeds 40 mm
• Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
• Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, EKG, and/or laboratory screening test
• Pregnant or lactating female, or female who intends to become pregnant during the study period
• Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection

• Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry

  • For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
  • Inhaled and topical steroids are allowed
• Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
• Syncopal episode within 12 months of screening
• Suspected or known current alcohol abuse as defined by the American Psychiatric Association in DSM IV (Diagnostic and Statistical Manual of Mental Disorders-4th edition)
• Chronic or active illicit and/or intravenous drug use
• Unwilling to allow storage and use of blood for future hantavirus-related research
• Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study