ElectroPoration In a Clinical Setting

NCT04698694 | Completed

• 1 other identifier: EPIC trial
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tolerance

Keywords

coronavirus infection; vaccine; intramuscular electroporation

Outcome Measures

Primary Outcomes (3)

• Pain of intramuscular delivery of a sterile solution followed by electroporation

  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".

  approximately 1 month

• Discomfort level of intramuscular delivery of a sterile solution followed by electroporation

  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''.

  approximately 1 month

• Pain of intramuscular delivery of a sterile solution followed by electroporation

  Subjsects will rate the Perseption of Injection (PIN) questionnaire. Scores range from the minimum value 1 that means ''None'' to 5 that means ''very very much''.

  approximately 1 month

Secondary Outcomes (2)

• Incidence of Injection site Adverse Events

  approximately 1 month

• Incidence of sistemic Adverse Events

  approximately 1 month

Study Arms (2)

Subjects treated with Cliniporator® using a voltage amplitude of 40 V

EXPERIMENTAL

10 subjects deemed eligible are between 18-55 y of age respected the inclusion and exclusion criteria will be selected in a randomized way (1:1) and treated with a voltage amplitude of 40 V.

Device: Electroporation with voltage amplitude of 40 V (corresponding to an electric field strength of 100 V/cm)

Subjects treated with Cliniporator® using a voltage amplitude of 60 V

EXPERIMENTAL

10 subjects deemed eligible are between 18-55 y of age respected the inclusion and exclusion criteria will be selected in a randomized way (1:1) and treated with a voltage amplitude of 60 V.

Device: Electroporation with voltage amplitude of 60 V (corresponding to an electric field strength of 150 V/cm)

Interventions

Electroporation with voltage amplitude of 40 V (corresponding to an electric field strength of 100 V/cm) DEVICE

The physician will select the voltage amplitude of 40 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.

Subjects treated with Cliniporator® using a voltage amplitude of 40 V

Electroporation with voltage amplitude of 60 V (corresponding to an electric field strength of 150 V/cm) DEVICE

The physician will select the voltage amplitude of 60 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.

Subjects treated with Cliniporator® using a voltage amplitude of 60 V

Eligibility Criteria

• Age: 18 Months - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Normal ECG
• CPK within normal reference range
• Non-pregnant women of childbearing potential, non-breastfeeding
• Able and willing to comply with all study procedures.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Rottapharm: collaborator

Study Sites (1)

ASST Monza-Ospedale San Gerardo

Monza, Italy

Location

Related Publications (4)

• Frelin L, Brass A, Ahlen G, Brenndorfer ED, Chen M, Sallberg M. Electroporation: a promising method for the nonviral delivery of DNA vaccines in humans? Drug News Perspect. 2010 Dec;23(10):647-53. doi: 10.1358/dnp.2010.23.10.1513492.

  PMID: 21180650 BACKGROUND

• Mir LM. Application of electroporation gene therapy: past, current, and future. Methods Mol Biol. 2008;423:3-17. doi: 10.1007/978-1-59745-194-9_1.

  PMID: 18370187 BACKGROUND

• Paul-Dauphin A, Guillemin F, Virion JM, Briancon S. Bias and precision in visual analogue scales: a randomized controlled trial. Am J Epidemiol. 1999 Nov 15;150(10):1117-27. doi: 10.1093/oxfordjournals.aje.a009937.

  PMID: 10568628 BACKGROUND

• Rizzuto G, Cappelletti M, Maione D, Savino R, Lazzaro D, Costa P, Mathiesen I, Cortese R, Ciliberto G, Laufer R, La Monica N, Fattori E. Efficient and regulated erythropoietin production by naked DNA injection and muscle electroporation. Proc Natl Acad Sci U S A. 1999 May 25;96(11):6417-22. doi: 10.1073/pnas.96.11.6417.

  PMID: 10339602 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Electroporation

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Cytological Techniques; Clinical Laboratory Techniques; Investigative Techniques; Electrochemical Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The subjects and investigators will remain blind with respect to the voltage strength received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty (20) subjects will be randomized 1:1 to one of the following EP conditions: 1. voltage amplitude of 40 V (10 subjects) 2. voltage amplitude of 60 V (10 subjects).

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 7, 2021
• Study Start: December 9, 2020
• Primary Completion: December 14, 2020
• Study Completion: December 21, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)