Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19

NCT04447781 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: IVI COVID19-001
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO- 4800 contains the plasmid pGX9501, which encodes for the full length of the Spike glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will proceed sequentially.

Conditions

Coronavirus Infection; SARS-CoV 2

Keywords

Coronavirus Infection; SARS-CoV 2; INO-4800

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measures

  * Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays \[Immunogenicity\] * Incidence of adverse events among participants during the study period \[Safety and Tolerability\] * Percentage of Participants with Administration (Injection) Site Reactions \[Safety and Tolerability\] * Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period \[Safety and Tolerability\]

  Baseline up to Week 52

Study Arms (4)

Group 1 (Part A)

EXPERIMENTAL

* Number of Subjects: 20 subjects * ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)

Biological: INO-4800; Device: CELLECTRA® 2000

Group 2 (Part A)

EXPERIMENTAL

* Number of Subjects: 20 subjects * ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)

Biological: INO-4800; Device: CELLECTRA® 2000

Group 3 (Part B)

EXPERIMENTAL

* Number of Subjects: 90 subjects * ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)

Biological: INO-4800; Device: CELLECTRA® 2000

Group 4 (Part B, Placebo)

PLACEBO COMPARATOR

* Number of Subjects: 30 subjects * ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4)

Device: CELLECTRA® 2000; Other: Saline-sodium citrate (SSC) buffer

Interventions

INO-4800 BIOLOGICAL

\- Manufacturer: Inovio Pharmaceuticals Inc.

Group 1 (Part A); Group 2 (Part A); Group 3 (Part B)

CELLECTRA® 2000 DEVICE

\- Manufacturer: Inovio Pharmaceuticals Inc.

Group 1 (Part A); Group 2 (Part A); Group 3 (Part B); Group 4 (Part B, Placebo)

Saline-sodium citrate (SSC) buffer OTHER

\- Manufacturer: Inovio Pharmaceuticals Inc.

Also known as: Placebo

Group 4 (Part B, Placebo)

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures
• Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B)
• Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening
• Able and willing to comply with all study procedures
• Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator
• Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening
• Screening ECG and Chest X-ray deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
• Must meet one of the following criteria with respect to reproductive capacity:
• a. Women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. Use of medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose. Acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)

You may not qualify if:

• Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose
• Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing
• Is currently participating in or has participated in a study with an investigational product within 6 months preceding Day 0
• Receipt of an investigational product for prophylaxis or treatment of COVID-19, MERS or SARS
• Body mass index (BMI) \<18 or \>30
• Current or history of the following medical conditions:
• Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease);
• Hypertension, resting systolic blood pressure \>150 mm Hg or a diastolic blood pressure \>95 mm Hg
• Malignancy within 5 years of screening
• Cardiovascular diseases (e.g., myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias)
• Diabetes mellitus
• Use of immunoglobulin or blood products in last 6 months
• History of severe allergic reaction or anaphylaxis after immunization
• Immunosuppression as a result of underlying illness or treatment including:
• Primary immunodeficiencies

Sponsors & Collaborators

• International Vaccine Institute: lead
• Coalition for Epidemic Preparedness Innovations: collaborator
• Inovio Pharmaceuticals: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

reluscovtogene ralaplasmid; Buffers

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Myoung-don Oh, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Eu Suk Kim, MD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A: Open Label Part B: Double-blind
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 25, 2020
• Study Start: July 15, 2020
• Primary Completion: July 12, 2021
• Study Completion: May 25, 2022
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 3 years following the end of the study.
• Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

Locations

KR (2)