NCT04336410

Brief Summary

This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.9 years

First QC Date

April 3, 2020

Last Update Submit

April 13, 2022

Conditions

Coronavirus Infection

Keywords

DNA vaccineElectroporation

Outcome Measures

Primary Outcomes (5)

  • Percentage of Participants with Adverse Events (AEs)

    Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)

  • Percentage of Participants with Administration (Injection) Site Reactions

    Day 0 up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)

  • Percentage of Participants with Adverse Events of Special Interest (AESIs)

    Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)

  • Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers

    Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)

  • Change from Baseline in Antigen-Specific Cellular Immune Response

    Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)

Study Arms (3)

Group 1: INO-4800

EXPERIMENTAL

Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.

Drug: INO-4800Device: CELLECTRA® 2000

Group 2: INO-4800

EXPERIMENTAL

Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.

Drug: INO-4800Device: CELLECTRA® 2000

Group 3: INO-4800

EXPERIMENTAL

Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.

Drug: INO-4800Device: CELLECTRA® 2000

Interventions

INO-4800DRUG

INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.

Group 1: INO-4800Group 2: INO-4800Group 3: INO-4800
CELLECTRA® 2000DEVICE

EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.

Group 1: INO-4800Group 2: INO-4800Group 3: INO-4800

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 or deemed not clinically significant by the Investigator.
  • Body Mass Index of 18-30 kg/m\^2, inclusive, at screening.
  • Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening.
  • Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome).
  • 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, be post-menopausal, be surgically sterile or have a partner who is sterile.

You may not qualify if:

  • Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial from screening until 3 months following last dose.
  • Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0.
  • Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
  • In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients).
  • Current or history of the following medical conditions:
  • Respiratory diseases
  • Hypersensitivity or severe allergic reactions to vaccines or drugs
  • Diagnosis of diabetes mellitus
  • Hypertension
  • Malignancy within 5 years of screening
  • Cardiovascular diseases
  • Immunosuppression as a result of underlying illness or treatment including:
  • Primary immunodeficiencies
  • Long term use (≥7 days) of oral or parenteral glucocorticoids
  • Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Central Kentucky Research Associates

Lexington, Kentucky, 40509, United States

Location

Center for Pharmaceutical Research

Kansas City, Missouri, 64114, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • Kraynyak KA, Blackwood E, Agnes J, Tebas P, Giffear M, Amante D, Reuschel EL, Purwar M, Christensen-Quick A, Liu N, Andrade VM, Diehl MC, Wani S, Lupicka M, Sylvester A, Morrow MP, Pezzoli P, McMullan T, Kulkarni AJ, Zaidi FI, Frase D, Liaw K, Smith TRF, Ramos SJ, Ervin J, Adams M, Lee J, Dallas M, Shah Brown A, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM, Boyer JD, Mammen MP. SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial. J Infect Dis. 2022 Jun 1;225(11):1923-1932. doi: 10.1093/infdis/jiac016.

    PMID: 35079784DERIVED

  • Tebas P, Yang S, Boyer JD, Reuschel EL, Patel A, Christensen-Quick A, Andrade VM, Morrow MP, Kraynyak K, Agnes J, Purwar M, Sylvester A, Pawlicki J, Gillespie E, Maricic I, Zaidi FI, Kim KY, Dia Y, Frase D, Pezzoli P, Schultheis K, Smith TRF, Ramos SJ, McMullan T, Buttigieg K, Carroll MW, Ervin J, Diehl MC, Blackwood E, Mammen MP, Lee J, Dallas MJ, Brown AS, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. EClinicalMedicine. 2021 Jan;31:100689. doi: 10.1016/j.eclinm.2020.100689. Epub 2020 Dec 24.

    PMID: 33392485DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

reluscovtogene ralaplasmid

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Dr. Ning Jiang, MD PhD

    Inovio Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

April 3, 2020

Primary Completion

February 10, 2022

Study Completion

February 10, 2022

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.

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 10 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

US(3)