A Phase I, Randomized, Observer-blind, Placebo Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Venezuelan Equine Encephalitis DNA Vaccine Candidate Administered Intramuscularly or Intradermally by Electroporation to Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- The nature, frequency, and severity of local and systemic adverse events or serious adverse events associated with electroporation-based administration of the VEEV DNA vaccine candidate
研究概览
简要总结
The Phase I study will assess the basic safety, tolerability, and immunogenicity of a DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will comprise evaluation of intradermal or intramuscular administration by electroporation. Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0 mg/ml) for each route of administration. Electroporation will be administered using the TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional group of subjects will serve as a placebo control, receiving injections of saline with electroporation. The overall goal of this study will be to determine if further human clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection of dose and route of administration for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at time of screening
- •Have provided written informed consent before screening
- •Free of clinically significant health problems or clinical lab abnormalities, as determined by pertinent medical history, lab evaluations, 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, anatomical sterility [self or partner]) from the date of screening until at least 6 months after the last injection
- •Negative VEEV IgG antibody test result at screening (ELISA)
排除标准
- •History or serologic evidence of prior infection with VEE virus or prior participation in a VEE virus vaccine trial
- •History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
- •History of Guillain-Barre Syndrome
- •Ongoing participation in another clinical trial
- •Receipt or planned receipt of any experimental or licensed vaccine, except for a licensed seasonal influenza vaccine, within the period 30 days prior to initial injection through 60 days after the Day 70 follow-up. (~ 6 month period in total)
- •Receipt or planned receipt of any allergy treatments involving antigen injections within the period 30 days prior to the first injection through the period 60 days after Study Day 70 (~6 month period in total)
- •Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for the eligible injection sites (left and right medial 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
- •Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
- •Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or 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 HIV infection
- •Administration of chronic (defined as more than 14 days) immunosuppressant's 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 by history
- •Unwilling to allow storage and use of blood for future alphavirus-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
研究组 & 干预措施
VEEV DNA Vaccine 0.5 mg/ml Intramuscular
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
干预措施: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate (Biological)
VEEV DNA Vaccine 0.5 mg/ml Intradermal
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
干预措施: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate (Biological)
VEEV DNA Vaccine 2.0 mg/ml Intramuscular
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
干预措施: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate (Biological)
VEEV DNA Vaccine 2.0 mg/ml Intradermal
Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate
干预措施: Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate (Biological)
Placebo: 0.9% saline
0.9% saline
干预措施: 0.9% saline placebo (Other)
结局指标
主要结局
The nature, frequency, and severity of local and systemic adverse events or serious adverse events associated with electroporation-based administration of the VEEV DNA vaccine candidate
时间窗: 12 months
次要结局
- The frequency, magnitude, and duration of serum anti-VEEV antibody responses(12 months)
- Response to a questionnaire based assessment of acute procedure tolerability.(8 weeks)