Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT04336410
• Recruitment Status: Active, not recruiting
• First Posted: April 7, 2020
• Last Update Posted: January 10, 2022
• Sponsor: Inovio Pharmaceuticals
• Collaborator: Coalition for Epidemic Preparedness Innovations
• Information provided by (Responsible Party): Inovio Pharmaceuticals

Tracking Information

• First Submitted Date: April 3, 2020
• First Posted Date: April 7, 2020
• Last Update Posted Date: January 10, 2022
• Actual Study Start Date: April 3, 2020
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2021)

• 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) ]

Original Primary Outcome Measures (submitted: April 3, 2020)

• Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Week 28 ]
• Percentage of Participants with Administration (Injection) Site Reactions [ Time Frame: Day 0 up to Week 28 ]
• Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Week 28 ]
• Change from Baseline in Antigen-Specific Binding Antibody Titers [ Time Frame: Baseline up to Week 28 ]
• Change from Baseline in Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response [ Time Frame: Baseline up to Week 28 ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers
• Official Title: 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
• 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: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Coronavirus Infection

Intervention

• 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.

Study Arms

• 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.
  Interventions:

  • Drug: INO-4800
  • Device: CELLECTRA® 2000
• 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.
  Interventions:

  • Drug: INO-4800
  • Device: CELLECTRA® 2000
• Experimental: 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.
  Interventions:

  • Drug: INO-4800
  • Device: CELLECTRA® 2000

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 3, 2020): 120
• Original Estimated Enrollment (submitted: April 3, 2020): 40
• Estimated Study Completion Date: January 2022
• Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)

Eligibility 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.
• 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.

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04336410
• Other Study ID Numbers: COVID19-001
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
• Supporting Materials: Study Protocol
• Supporting Materials: 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.

• Responsible Party: Inovio Pharmaceuticals
• Study Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations

Investigators

• Study Director: Dr. Ning Jiang, MD PhD; Inovio Pharmaceuticals

• PRS Account: Inovio Pharmaceuticals
• Verification Date: January 2022