A Phase I, Randomized, Observer-Blind Trial to Assess the Safety, Reactogenicity and Immunogenicity of a Venezuelan Equine Encephalitis (VEE) DNA Vaccine Candidate Administered Intramuscularly and Intradermally by Jet Injection to Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of participants with immediate reactions
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and reactogenicity of a VEE DNA Vaccine candidate delivered by either intramuscular or intradermal jet injection. The main question it aims to answer is:
• Is the VEE DNA Vaccine candidate safe
Participants will:
- Receive the VEE DNA Vaccine candidate by either intramuscular or intradermal jet injection
- Provide blood and urine samples
- Complete ECGs
- Complete physical exams
- Complete diaries
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
- Double (Participant, Investigator)
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 adults, male or female.
- •Ages at least 18 at the start of the study and no greater than 49 years of age on Day 1 of vaccination.
- •Participants must be available for all visits and for the complete duration of the study.
- •Participants must, in the opinion of the Investigator or person obtaining consent, understand the information provided and be capable of providing informed consent.
- •Women of child bearing potential (WOCBP) must have a negative pregnancy test and be willing to use an effective method of contraception: oral contraception, diaphragm, cervical cap, intrauterine device, condom, or be anatomically sterile (in self or partner) from the date of screening until at least 6 months after the last vaccination.
- •If subject is a sexually active male, must be willing to use an effective method of contraception (such as condoms or be anatomically sterile) from screening until 6 months after the last vaccination.
排除标准
- •Clinically relevant abnormality on history or examination including a history of immunodeficiency or use of systemic corticosteroids, immunosuppressive, anticancer, or other medications considered to be significant by the designated trial physician in the last 6 months.
- •Any acute or chronic medical condition requiring care of a physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the Investigator, would preclude participation.
- •Any of the following laboratory parameters with abnormal values that are moderate in severity: hematology (hemoglobin, absolute neutrophil count, absolute lymphocyte count, platelets); urinalysis; biochemistries (total bilirubin, creatinine, AST, ALT).
- •If female, pregnant, lactating, or planning pregnancy within 6 months of the final vaccination.
- •Receipt of a blood transfusion or blood products 6 months prior to enrollment.
- •Participation in another clinical trial of an investigational product currently or within the past 12 weeks or expected participation during the study.
- •History of severe local or systemic reactions to vaccination or a history of severe allergic reactions.
- •History of Guillain-Barre syndrome.
- •Confirmed diagnosis of HBV infection (surface antigen positive, HBsAg); Hepatitis C infection (HCV Ab positive); HIV infection, or active syphilis.
- •History of grand mal epilepsy, or currently taking anti-epileptics.
- •Any condition associated with prolonged bleeding time, which would contraindicate skin or muscle injection.
- •Abnormal ECG finding that, in the opinion of the Investigator, excludes the subject from participating.
- •History of syncope or history of a fainting episode within one year of study entry.
- •Extensive tattoos or markings covering the eligible sites of administration (the skin or muscle of the upper left and right deltoid muscles).
- •Presence of any surgical/traumatic metal implants, or significant scar tissue that may impair appropriate injection at the eligible sites of administration (skin or muscle of the upper left and right deltoid muscles).
- •In the opinion of the Investigator, is unlikely to comply with the protocol.
- •As confirmed/reported by the study subject, a history of: exposure to Venezuelan Equine Encephalitis Virus (VEEV) or related alphavirus; prior immunization with an alphavirus replicon-based vaccine; prior immunization with a live-attenuated alphavirus vaccine; prior immunization with an inactivated alphavirus vaccine.
- •A history of encephalitis as confirmed/reported by the study subject.
- •Prior immunization against VEEV or related alphavirus or encephalitis, as confirmed/reported by the study subject.
- •History of alcohol abuse, illicit drug use, physical dependence on any opioid, or any history of drug abuse (excluding marijuana) or addiction within 12 months of screening.
- •Involved in the planning or conduct of the study.
研究组 & 干预措施
1: Intramuscular
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
干预措施: Venezuelan Equine Encephalitis DNA Vaccine (Drug)
1: Intramuscular
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
干预措施: PharmaJet Stratis Needle-free Injection System (Device)
2: Intramuscular
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
干预措施: Venezuelan Equine Encephalitis DNA Vaccine (Drug)
2: Intramuscular
Route (device): Intramuscular (PharmaJet Stratis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
干预措施: PharmaJet Stratis Needle-free Injection System (Device)
3: Intradermal
Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
干预措施: Venezuelan Equine Encephalitis DNA Vaccine (Drug)
3: Intradermal
Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 4, 8 Saline dose schedule (week): 26
干预措施: PharmaJet Tropis Needle-free Injection System (Device)
4: Intradermal
Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
干预措施: Venezuelan Equine Encephalitis DNA Vaccine (Drug)
4: Intradermal
Route (device): Intradermal (PharmaJet Tropis Needle-free Injection System) Vaccine dose schedule (week): 0, 8, 26 Saline dose schedule (week): 4
干预措施: PharmaJet Tropis Needle-free Injection System (Device)
结局指标
主要结局
Number of participants with immediate reactions
时间窗: 30 minutes after each vaccination
The nature, frequency, and severity of immediate reactions following vaccination
Solicited adverse events
时间窗: 7 days after each vaccination
The nature, frequency, and severity of solicited adverse events
Unsolicited adverse events
时间窗: 28 days after the final vaccination
The nature, frequency, and severity of unsolicited adverse events
Adverse events
时间窗: 1 year
The nature, frequency, and severity of adverse events
次要结局
- VEEV-specific antibody(1 year)
- Seroconversion rate(1 year)