Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers
Latest Information Update: 10 Mar 2022
At a glance
- Drugs INO 4800 (Primary)
- Indications COVID 2019 infections
- Focus Adverse reactions; First in man; Pharmacodynamics
- Sponsors Inovio Pharmaceuticals
Most Recent Events
- 04 Mar 2022 Status changed from active, no longer recruiting to completed.
- 25 Jan 2022 Results published in the Journal of Infectious Diseases
- 12 Oct 2021 According to an Inovio Pharmaceuticals Media Release , data from this trial is available in the online preprint publication in MedRxiv
Trial Overview
Purpose
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.
Primary Endpoints
Percentage of Participants with Adverse Events (AEs)
time_frame: 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
time_frame: 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)
time_frame: 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
time_frame: 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
time_frame: 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)
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | prevention | - |
Subjects
- Subject Type patients
-
Number
Planned: 120
Actual: 120
- Sex male & female
- Age Group ≥ 18 years; adult
Patient 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. - 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.
Patient 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 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 - 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 available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles. - Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence. - 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.
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04336410 | ClinicalTrials.gov: US National Institutes of Health |
COVID19-001 | - |
Organisations
- Sponsors Inovio Pharmaceuticals
- Affiliations Inovio Pharmaceuticals
Trial Dates
-
Initiation Dates
Planned : 01 Apr 2020
Actual : 03 Apr 2020
-
Primary Completion Dates
Planned : 01 Jan 2022
Actual : 10 Feb 2022
-
End Dates
Planned : 01 Jan 2022
Actual : 10 Feb 2022
Other Details
- Design multicentre; open; prospective; sequential
- Phase of Trial Phase I
- Location USA
- Focus Adverse reactions; First in man; Pharmacodynamics
Interventions
Drugs | Route | Formulation | Target |
---|---|---|---|
INO 4800 Primary Drug
|
Intradermal | Injection | CD4-positive T-lymphocyte, CD8 positive T lymphocyte |
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, Week 4 and at the optional Booster Dose Visit.) Device: CELLECTRA® 2000 (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 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, Week 4 and at the optional Booster Dose Visit.) Device: CELLECTRA® 2000 (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 3: INO-4800
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-4800 (INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.) Device: CELLECTRA® 2000 (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.)
Results
Publications
-
Tebas P, Agnes J, Giffear M, Kraynyak KA, Blackwood E, Amante D, et al. Safety and Immunogenicity of INO-4800, a COVID-19 DNA Vaccine as a Primary Series and Booster. IDW-2021 2021; abstr. 571.
Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S387/6450012 -
Inovio Pharmaceuticals. INOVIO's COVID-19 Vaccine Candidate, INO-4800, Provides Broad Cross-reactive Immune Responses In Humans Against Variants of Concern. Media-Rel 2021;.
Media Release -
Kraynyak KA, Blackwood E, Agnes J, Tebas P, Giffear M, Amante D, et al. 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;.
PubMed | CrossRef Fulltext -
Inovio Pharmaceuticals. INOVIO Announces Online Preprint Publication of Homologous Boosting Data for its COVID-19 DNA Vaccine Candidate, INO-4800. Media-Rel 2021;.
Media Release
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Inovio Call Center
(267) 440-4237
show details
clinical.trials@inovio.com |
, Inovio Pharmaceuticals |
-
|
Program Manager, Barbara Bradshaw
clinicaltrialsKC@amrllc.com
show details
|
Center for Pharmaceutical Research | USA |
Program Manager, Eileen Donaghy
PennCovidVaccine@pennmedicine.upenn.edu
show details
|
University of Pennsylvania | USA |
Program Manager, Ginger Switzer
amrlexington@amrllc.com
show details
|
Central Kentucky Research Associates | USA |
ShuPing Yang, MD, PhD | Inovio Pharmaceuticals |
-
|
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
Center for Pharmaceutical Research | Kansas City, Missouri | USA |
Central Kentucky Research Associates | Lexington, Kentucky | USA |
Coalition for Epidemic Preparedness Innovations (CEPI) |
-
|
-
|
Inovio Pharmaceuticals |
-
|
-
|
Inovio Pharmaceuticals |
-
|
-
|
University of Pennsylvania | Philadelphia, Pennsylvania | USA |
Trial History
Event Date | Event Type | Comment |
---|---|---|
10 Mar 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 10 Mar 2022 |
04 Mar 2022 | Status change - completed | Status changed from active, no longer recruiting to completed. Updated 10 Mar 2022 |
25 Jan 2022 | Results | Results published in the Journal of Infectious Diseases Updated 04 Feb 2022 |
12 Oct 2021 | Other trial event | According to an Inovio Pharmaceuticals Media Release , data from this trial is available in the online preprint publication in MedRxiv Updated 19 Oct 2021 |
12 Oct 2021 | Results | Results published in the Inovio Pharmaceuticals Media Release Updated 19 Oct 2021 |
03 Oct 2021 | Results | Results presented at the IDWeek 2021 Updated 05 Feb 2022 |
15 Apr 2021 | Other trial event | According to an Inovio Pharmaceuticals Media Release data submitted for peer review and available via preprint in bioRxiv. Updated 21 Apr 2021 |
15 Apr 2021 | Results | Results presented in an Inovio Pharmaceuticals Media Release. Updated 21 Apr 2021 |
19 Jan 2021 | Completion date | Planned End Date changed from 1 Jul 2021 to 1 Jan 2022. Updated 25 Jan 2021 |
19 Jan 2021 | Other trial event | Planned primary completion date changed from 1 Jul 2021 to 1 Jan 2022. Updated 25 Jan 2021 |
10 Aug 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting. Updated 13 Aug 2020 |
10 Aug 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the study has expanded with 80 additional participants age 18 and up, with no upper age limit, and with the inclusion of a low-dose arm and the study extension was fully enrolled by mid-July. Updated 13 Aug 2020 |
10 Aug 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company has submitted the full clinical data to a peer-reviewed medical journal. Updated 13 Aug 2020 |
30 Jun 2020 | Protocol amendment | According to an Inovio Pharmaceuticals media release, the company has expanded this study to add older participants in additional cohorts Updated 05 Jul 2020 |
30 Jun 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company plans to publish the full data set in a peer-reviewed medical journal. Updated 05 Jul 2020 |
30 Jun 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, an independent Data Safety Monitoring Board reviewed the safety data from this study. Updated 05 Jul 2020 |
30 Jun 2020 | Interim results | Results from the first two cohorts of this study are presented in an Inovio Pharmaceuticals media release. Updated 05 Jul 2020 |
03 Jun 2020 | Status change - recruiting | Status changed from active, no longer recruiting to recruiting. Updated 08 Jun 2020 |
03 Jun 2020 | Protocol amendment | Number of arms changed from 2 to 3, Experimental arm: Group 3: INO-4800 added. Planned patient number has also increased. Updated 08 Jun 2020 |
03 Jun 2020 | Other trial event | Planned number of patients changed from 40 to 120. Updated 08 Jun 2020 |
03 Jun 2020 | Completion date | Planned End Date changed from 1 Apr 2021 to 1 Jul 2021. Updated 08 Jun 2020 |
03 Jun 2020 | Other trial event | Planned primary completion date changed from 1 Apr 2021 to 1 Jul 2021. Updated 08 Jun 2020 |
30 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, INOVIO plans to produce one million doses of INO-4800 by the end of 2020. Updated 08 May 2020 |
30 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, INOVIO today announced that it has entered into an agreement to expand its manufacturing partnership with the German contract manufacturer Richter-Helm BioLogics GmbH & Co. KG, to support large-scale manufacturing of INOVIOs investigational DNA vaccine INO-4800, which currently is in Phase 1 clinical testing in the U.S. (NCT04336410) for COVID-19 and could potentially advance to Phase 2/3 efficacy trial (CT profile 320589) this summer. Updated 08 May 2020 |
28 Apr 2020 | Status change - active, no longer recruiting | Status changed from recruiting to active, no longer recruiting according to an Inovio Pharmaceuticals media release. Updated 30 Apr 2020 |
28 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, Lead Principal Investigator of this study is Pablo Tebas, M.D., infectious disease specialist and Professor of Medicine at the Hospital of the University of Pennsylvania Updated 30 Apr 2020 |
28 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, this trial is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June. Updated 30 Apr 2020 |
21 Apr 2020 | Completion date | Planned End Date changed from 1 Nov 2020 to 1 Apr 2021. Updated 27 Apr 2020 |
21 Apr 2020 | Other trial event | Planned primary completion date changed from 1 Nov 2020 to 1 Apr 2021. Updated 27 Apr 2020 |
08 Apr 2020 | Other trial event | New source identified and integrated ClinicalTrials.gov: (US National Institutes of Health: NCT04336410). Updated 13 Apr 2020 |
07 Apr 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 13 Apr 2020 |
06 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, Pablo Tebas is the principal investigator of this study. Updated 08 Apr 2020 |
06 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the initial immune responses and safety data from the study are expected by late summer 2020. Updated 08 Apr 2020 |
06 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, this study will enroll up to 40 healthy adult volunteers in Philadelphia, PA (at the Perelman School of Medicine at the University of Pennsylvania) and Kansas City, MO (at the Center for Pharmaceutical Research), where screening of potential participants has already begun. Study supplies of INO-4800 arrived at the sites last week. Updated 08 Apr 2020 |
06 Apr 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the U.S. Food and Drug Administration has accepted the company's Investigational New Drug (IND) application for INO-4800 to prevent COVID-19 infection, paving the way for Phase 1 clinical testing of INO-4800 in healthy volunteers beginning this week. The first dosing is planned for today. Updated 08 Apr 2020 |
06 Apr 2020 | Status change - recruiting | Status changed from planning to recruiting, according to an Inovio Pharmaceuticals media release. Updated 08 Apr 2020 |
12 Mar 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company plans to advance this study in April 2020. Updated 16 Mar 2020 |
03 Mar 2020 | Other trial event | According to Inovio Pharmaceuticals, Inc. media release, the company plans to publish/present results in Fall 2020. Updated 09 Mar 2020 |
03 Mar 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, the company plans to initiate this trial in April 2020. Updated 09 Mar 2020 |
05 Feb 2020 | New trial record | New trial record Updated 05 Feb 2020 |
30 Jan 2020 | Other trial event | According to an Inovio Pharmaceuticals media release, recently announced that it is developing INO-4800 through Phase 1 human testing in the U.S. to evaluate safety and immunogenicity with the support of an initial grant up to $9 million from the Coalition for Epidemic Preparedness Innovations (CEPI). Updated 05 Feb 2020 |
References
-
Inovio Pharmaceuticals. INOVIO Completes Enrollment in the Phase 1 U.S. Trial of INO-4800 for COVID-19 DNA Vaccine; Interim Results Expected in June. Media-Rel 2020;.
Media Release -
Tebas P, Agnes J, Giffear M, Kraynyak KA, Blackwood E, Amante D, et al. Safety and Immunogenicity of INO-4800, a COVID-19 DNA Vaccine as a Primary Series and Booster. IDW-2021 2021; abstr. 571.
Available from: URL: https://academic.oup.com/ofid/article/8/Supplement_1/S387/6450012 -
Inovio Pharmaceuticals. Inovio Collaborating With Beijing Advaccine To Advance INO-4800 Vaccine Against New Coronavirus In China. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. INOVIO and Richter-Helm BioLogics will expand existing DNA manufacturing agreement to support large-scale manufacturing of INO-4800INO-4800 Phase 2/3 U.S. clinical trial being prepared to start this summer. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. INOVIO's COVID-19 Vaccine Candidate, INO-4800, Provides Broad Cross-reactive Immune Responses In Humans Against Variants of Concern. Media-Rel 2021;.
Media Release -
Inovio Pharmaceuticals. INOVIO Receives New $5 Million Grant to Accelerate Scale Up of Smart Delivery Device for Its COVID-19 Vaccine. Media-Rel 2020;.
Media Release -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2024;.
Available from: URL: http://clinicaltrials.gov -
Kraynyak KA, Blackwood E, Agnes J, Tebas P, Giffear M, Amante D, et al. 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;.
PubMed | CrossRef Fulltext -
Inovio AS. INOVIO Announces Positive Interim Phase 1 Data For INO-4800 Vaccine for COVID-19. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. Inovio Accelerates Timeline for COVID-19 DNA Vaccine INO-4800. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. INOVIO Reports Second Quarter 2020 Financial Results; Provides DNA Medicines Clinical Program Mid-Year Update. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. INOVIO Initiates Phase 1 Clinical Trial Of Its COVID-19 Vaccine and Plans First Dose Today. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. INOVIO Highlights Anticipated 2025 Milestones and 2024 Key Accomplishments. Media-Rel 2025;.
Media Release -
Inovio Pharmaceuticals. INOVIO Announces Online Preprint Publication of Homologous Boosting Data for its COVID-19 DNA Vaccine Candidate, INO-4800. Media-Rel 2021;.
Media Release
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