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History of Changes for Study: NCT04336410
Safety, Tolerability and Immunogenicity of INO-4800 in Healthy Volunteers
Latest version (submitted April 13, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 3, 2020 None (earliest Version on record)
2 April 7, 2020 Recruitment Status, Study Status, Study Identification and Contacts/Locations
3 April 21, 2020 Study Status, Eligibility and Outcome Measures
4 June 3, 2020 Study Status, Contacts/Locations, Eligibility, Arms and Interventions and Study Design
5 July 2, 2020 Study Status
6 August 10, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
7 September 18, 2020 Study Status
8 January 13, 2021 Outcome Measures, Study Status, Contacts/Locations, Arms and Interventions and Oversight
9 January 19, 2021 Study Status and Outcome Measures
10 March 1, 2021 Study Status
11 May 27, 2021 Study Status
12 August 24, 2021 Study Status
13 October 1, 2021 Study Status
14 November 18, 2021 Study Status and Contacts/Locations
15 January 6, 2022 Study Status
16 March 4, 2022 Recruitment Status and Study Status
17 April 13, 2022 Study Status
Comparison Format:

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Study NCT04336410
Submitted Date:  April 3, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: COVID19-001
Brief Title: Safety, Tolerability and Immunogenicity of INO-4800 in Healthy Volunteers
Official Title: Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800 for a Novel Coronavirus (COVID-19) in Healthy Volunteers
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2020
Overall Status: Not yet recruiting
Study Start: April 2020
Primary Completion: November 2020 [Anticipated]
Study Completion: November 2020 [Anticipated]
First Submitted: April 3, 2020
First Submitted that
Met QC Criteria:
April 3, 2020
First Posted: April 7, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 3, 2020
Last Update Posted: April 7, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Inovio Pharmaceuticals
Responsible Party: Sponsor
Collaborators: Coalition for Epidemic Preparedness Innovations
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Coronavirus Infection
Keywords: DNA vaccine
Electroporation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 40 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Group 1: INO-4800
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-4800
INO-4800 will be administered ID on Day 0 and Week 4.
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.
Experimental: Group 2: INO-4800
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-4800
INO-4800 will be administered ID on Day 0 and Week 4.
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Week 4.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of Participants with Adverse Events (AEs)
[ Time Frame: Baseline up to Week 28 ]

2. Percentage of Participants with Administration (Injection) Site Reactions
[ Time Frame: Day 0 up to Week 28 ]

3. Percentage of Participants with Adverse Events of Special Interest (AESIs)
[ Time Frame: Baseline up to Week 28 ]

4. Change from Baseline in Antigen-Specific Binding Antibody Titers
[ Time Frame: Baseline up to Week 28 ]

5. Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response
[ Time Frame: Baseline up to Week 28 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 50 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • 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.
  • Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody 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.

Exclusion Criteria:

  • 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 vaccine product for the prevention of COVID-19, middle east respiratory syndrome (MERS) or severe acute respiratory syndrome (SARS).
  • Current or history of the following medical conditions:
    • Respiratory diseases
    • 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
    • History of solid organ or bone marrow transplantation
    • Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease
  • Fewer than two acceptable sites are available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles.
  • Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
Open or close this module Contacts/Locations
Central Contact Person: Inovio Call Center
Telephone: (267) 440-4237
Email: clinical.trials@inovio.com
Study Officials: ShuPing Yang, MD, PhD
Study Director
Inovio Pharmaceuticals
Locations: United States, Missouri
Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Contact:Contact: Program Manager Barbara Bradshaw clinicaltrialsKC@amrllc.com
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact:Contact: Program Manager Eileen Donaghy eileen.donaghy2@pennmedicine.upenn.edu
Open or close this module IPDSharing
Plan to Share IPD: Yes
Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Information:
Study Protocol
Informed Consent Form (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.
URL:
Open or close this module References
Links:
Available IPD/Information:

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