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About
The purpose of this study is:
• To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device
Secondary:
• To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.
Full description
The study will enroll 3 randomized groups of 9 subjects each, along with 3 alternates, for a total of 30 subjects. The study will include one group of subjects injected with the HTNV DNA vaccine, one group injected with the PUUV DNA vaccine, and one group injected with both HTNV and PUUV DNA vaccines (mixed), administered with the Ichor TDS-IM device. Subjects will receive one dose of vaccine on Days 0, 28, and 56 and will be followed until Day 240. Subjects will complete post-injection memory aids for 14 days after each injection.
Subjects will be evaluated for safety and immune response throughout the study.
Enrollment
Sex
Ages
Volunteers
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
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
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
Primary purpose
Allocation
Interventional model
Masking
31 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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