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

• ClinicalTrials.gov Identifier: NCT05430958
• Recruitment Status: Withdrawn
• First Posted: June 24, 2022
• Last Update Posted: November 17, 2022
• Sponsor: Inovio Pharmaceuticals
• Information provided by (Responsible Party): Inovio Pharmaceuticals

Tracking Information

• First Submitted Date: June 21, 2022
• First Posted Date: June 24, 2022
• Last Update Posted Date: November 17, 2022
• Estimated Study Start Date: October 2022
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 21, 2022)

• Percentage of Participants with Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Baseline up to Day 7 ]
• Percentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline up to Day 28 ]
• Percentage of Participants with Serious Adverse Events (SAEs) [ Time Frame: Baseline up to week 52 ]
• Percentage of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to week 52 ]
• Percentage of Participants with Incidence of medically attended AEs (MAAEs) [ Time Frame: Baseline up to week 52 ]
• Percentage of Participants with Change in SARS-CoV-2 pseudovirus neutralizing titers [ Time Frame: Baseline up to day 28 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 18, 2022)

• Number of Participants with a Change in SARS-CoV-2 pseudovirus neutralizing titers [ Time Frame: Baseline, Day 7, 14, 84, 180, 224, 280 and 365 post-booster ]
• Number of Participants with SARS-CoV-2 pseudovirus neutralizing titers [ Time Frame: Days 7, 14, 28, 84, 180, 224, 280 and 365 post-booster ]
• Number of Participants with ARS-CoV-2 Spike binding IgG and change in SARS-CoV-2 Spike binding IgG [ Time Frame: Days 7, 14, 28, 84, 180 and 365 post-booster ]
• Number of Participants with SARS-CoV-2 cellular immune response as measured by IFN-gamma ELISpot [ Time Frame: Day 14 post-booster ]

Original Secondary Outcome Measures (submitted: June 21, 2022)

• Change in SARS-CoV-2 pseudovirus neutralizing titers [ Time Frame: Baseline, Day 7, 14, 84, 180, 224, 280 and 365 post-booster ]
• SARS-CoV-2 pseudovirus neutralizing titers [ Time Frame: Days 7, 14, 28, 84, 180, 224, 280 and 365 post-booster ]
• ARS-CoV-2 Spike binding IgG and change in SARS-CoV-2 Spike binding IgG [ Time Frame: Days 7, 14, 28, 84, 180 and 365 post-booster ]
• SARS-CoV-2 cellular immune response as measured by IFN-gamma ELISpot [ Time Frame: Day 14 post-booster ]

• 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 COVID19 in Healthy Volunteers
• Official Title: Phase 1 Open Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Intradermal Booster Dose of INO-4800 Alone or in Combination With INO-9112 Followed by Electroporation, in Adults Who Completed a Primary Immunization Series Against SARS-CoV-2 With mRNA Vaccines
• Brief Summary: This is an open label, phase 1 clinical trial of an intra-dermal booster dose of INO-4800 alone or in combination with INO-9112 followed by electroporation (EP) among healthy adults at least 18 years of age, who previously completed their primary immunization series with mRNA vaccines against SARS-CoV-2 within 6-12 months prior to the booster dose.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Coronavirus Infection

Intervention

• Drug: INO-4800
  INO-4800 will be given at 0.8 or 1.6 mg for at least 6 months but no more than 12 months following the completion of a primary vaccination.
• Drug: INO-9112
  INO-9112 will be given in at various doses (dose of 0, 0.05, 0.10, 0.20 or 0.40 mg) in combination with INO-4800.
• Device: CELLECTRA® 2000
  Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800.

Study Arms

• Experimental: Group 1
  Single injection of 0.8 mg of INO-4800 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Device: CELLECTRA® 2000
• Experimental: Group 2
  Single injection of 0.8 mg of INO-4800 plus 0.05 mg of INO-9112 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Drug: INO-9112
  • Device: CELLECTRA® 2000
• Experimental: Group 3
  Single injection of 0.8 mg of INO-4800 plus 0.10 mg of INO-9112 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Drug: INO-9112
  • Device: CELLECTRA® 2000
• Experimental: Group 4
  Single injection of 0.8 mg of INO-4800 plus 0.20 mg of INO-9112 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Drug: INO-9112
  • Device: CELLECTRA® 2000
• Experimental: Group 5
  Two injections of 0.8 mg (1.6 mg total) of INO-4800 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Device: CELLECTRA® 2000
• Experimental: Group 6
  Two injections of 0.8 mg (1.6 mg total) of INO-4800 + 0.05 mg (0.1 mg total) of INO-9112 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Drug: INO-9112
  • Device: CELLECTRA® 2000
• Experimental: Group 7
  Two injections of 0.8 mg (1.6 mg total) of INO-4800 + 0.1 mg (0.20 mg total) of INO-9112 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Drug: INO-9112
  • Device: CELLECTRA® 2000
• Experimental: Group 8
  Two injections of 0.8 mg (1.6 mg total) of INO-4800 + 0.20 mg (0.40 mg total) of INO-9112 followed by EP administered at Day 0
  Interventions:

  • Drug: INO-4800
  • Drug: INO-9112
  • Device: CELLECTRA® 2000

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: November 12, 2022): 0
• Original Estimated Enrollment (submitted: June 21, 2022): 160
• Estimated Study Completion Date: March 2024
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy men and non-pregnant women at least 18 years of age;
• Able and willing to comply with all study procedures;
• Screening laboratory results within normal limits or deemed not clinically significant by the Investigator;
• Received full primary series doses of an approved or authorized mRNA vaccine at least 6 months but no more than 12 months prior to INO-4800 booster dose.

• Must meet one of the following criteria with respect to reproductive capacity:

  • Women who are post-menopausal as defined by reported spontaneous amenorrhea for ≥ 12 months;
  • Surgically sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrollment;
  • Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until Day 28 post booster dose.

Exclusion Criteria:

• Acute febrile illness with temperature >100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of breath, sore throat) within the prior 72 hours;
• Positive SARs-CoV-2 PCR test, if results are available prior to dosing;
• Pregnant or breastfeeding, or intending to become pregnant or intending to father children within the projected duration of the study starting from the Screening visit until Day 28 post booster dose;
• Positive pregnancy test during screening or immediately prior to booster dose;
• Positive HIV rapid test, Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody at Screening;
• Is currently participating or has participated in a study with an IP within 30 days preceding Day 0 (documented receipt of placebo in a previous study would be permissible for study eligibility);
• Currently participating in another study with an investigational product during the conduct of this study;
• Previous or planned receipt of any COVID-19 booster vaccine during the trial period

• Medical conditions as follows:

  • Respiratory diseases
  • History of hypersensitivity or severe allergic reaction
  • Uncontrolled hypertension
  • Uncontrolled diabetes mellitus
  • Malignancy within the past 2 years, with the exception of superficial skin
  • History of cardiovascular disease
  • History of myocarditis or pericarditis
  • History of seizures within the past 2 years
  • Underlying immunosuppressive illness
• Lack of acceptable sites for ID injection and EP
• Blood donation or transfusion within 1 month prior to Day 0;
• Reported alcohol or substance abuse/dependence or illicit drug use within the past year;
• Any non-study vaccine (e.g., influenza vaccine) within 2 weeks prior to the dose of IP.

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: Not Provided

Administrative Information

• NCT Number: NCT05430958
• Other Study ID Numbers: COVID19-131
• 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: No

• Current Responsible Party: Inovio Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Inovio Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jose Suaya, MD; Inovio Pharmaceuticals

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