Tolerability of Intramuscular Electroporation Delivery by Cliniporator® in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Discomfort level of intramuscular delivery of a sterile solution followed by electroporation
研究概览
简要总结
This is a single-blind, single-center, randomized, study in healthy subjects in which the volunteer patients will remain blind with respect to the voltage strength received.
详细描述
Background:
The major obstacle to the preventive or therapeutic success of DNA vaccines is undoubtedly their delivery. If this cannot be made simple, cheap and effective, they may not become a viable option for human use. Numerous clinical trials have confirmed that a standard needle and syringe parenteral (mainly intramuscular or intradermal) delivery is not enough. An important tenet, confirmed by different DNA immunization studies, is that electroporation dramatically enhances the expression of the encoded antigen as well as the potency and immunogenicity of DNA vaccines. Electroporation (EP) creates transient increases in cell membrane permeability, thus enhancing DNA uptake and leading to a more robust immune response. EP involves the application of brief electric pulses to tissue in order to permeabilize cell membranes in a transient and reversible manner. The temporary formation of pores facilitate successful transport of macromolecules, like DNA, that occurs on the order of microseconds vs. minutes in the case of passive diffusion alone. EP is considered a safe and well validated procedure that can easily be handled as an out-patient procedure. In this regard, electrochemotherapy and electro gene transfer with the Cliniporator® (IGEA Srl, Carpi, Italy) has been added to clinical practice.
Aim of the present study is therefore to formally confirm the tolerability of electroporation given by the EPSGT gun and the Cliniporator® device in a clinical setting of healthy volunteers, prior to the phase I/II study of the COVID-19 vaccine in a similar population.
Study Design:
Twenty (20) subjects will be randomized 1:1 to one of the following EP conditions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
The subjects and investigators will remain blind with respect to the voltage strength received.
入排标准
- 年龄范围
- 18 Months 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent obtained before undergoing any study-specific procedure
- •Healthy subjects, as determined by a responsible physician, based on a medical evaluation including medical history and physical examination
- •Males or females aged ≥18 and ≤ 55 years
- •A minimum weight of 50 kg and Body Mass Index >18.5 and ≤30 kg/m2
- •Vital signs within the following values or ranges:
- •Body temperature ≤ 37,5 °C
- •Pulse frequency ≥51 and ≤100 beats per minute
- •Diastolic BP ≥60 mmHg, ≤ 90 mmHg
- •Systolic BP ≥ 90 mmHg, ≤ 140 mmHg
- •CPK within normal reference range
- •Non-pregnant women of childbearing potential, non-breastfeeding
- •Able and willing to comply with all study procedures.
排除标准
- •Any past or present cardiac disease, even if not evident at ECG
- •Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor deficiency) or prior history of significant bleeding or bruising following IM injections or venepuncture
- •History of seizures or mental illness
- •Metal implants within 20 cm of the planned site(s) of injection
- •Presence of keloid scar formation or hypertrophic scar, or other clinically significant medical condition at the planned site(s) of injection
- •Any abnormality or permanent body art (e.g. tattoos) that would interfere with the ability to observe local reactions at the injection site in the deltoid area
- •History of alcohol or drug abuse during the 12 months preceding the screening
- •Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant during the study
- •Breastfeeding
- •Any other clinically relevant disease and condition that, in the opinion of the Investigator, may jeopardize efficacy or safety assessments or may compromise the subject's safety during trial participation.
结局指标
主要结局
Discomfort level of intramuscular delivery of a sterile solution followed by electroporation
时间窗: approximately 1 month
Subjsects will rate discomfort level using an 11-point Numerical Rating Scale (NRS). Scores range from the minimum value 0 that means ''None'' to 10 that means ''Severe''.
Pain of intramuscular delivery of a sterile solution followed by electroporation
时间窗: approximately 1 month
Subjsects will rate the intramuscolar pain using the Visual Analog Scale (VAS) to rate the level of pain experienced from the minimum value of "No Pain" and the maximum value "Pain as bad as it could possibly be".
次要结局
- Incidence of Injection site Adverse Events(approximately 1 month)
- Incidence of sistemic Adverse Events(approximately 1 month)