Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT04588428
• Recruitment Status: Recruiting
• First Posted: October 19, 2020
• Last Update Posted: July 19, 2022
• Sponsor: Inovio Pharmaceuticals
• Collaborator: Coalition for Epidemic Preparedness Innovations
• Information provided by (Responsible Party): Inovio Pharmaceuticals

Tracking Information

• First Submitted Date: October 6, 2020
• First Posted Date: October 19, 2020
• Last Update Posted Date: July 19, 2022
• Actual Study Start Date: June 21, 2021
• Estimated Primary Completion Date: June 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 13, 2020)

• Frequency of Adverse Events in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage of Participants with Adverse Events in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Frequency of Injection Site Reactions in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage of Participants with Injection Site Reactions in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Frequency of Adverse Events of Special Interest (AESIs) in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage Antigen Specific Cellular Immune Response in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage of Seroconverted Participants in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Percentage of Participants with Overall Immune Response in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
• Frequency of Adverse Events in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage of Participants with Adverse Events in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Frequency of Injection Site Reactions in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage of Participants with Injection Site Reactions in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Frequency of Adverse Events of Special Interest (AESIs) in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage Antigen Specific Cellular Immune Response in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage of Seroconverted Participants in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
• Percentage of Participants with Overall Immune Response in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]

• Original Primary Outcome Measures: Same as current
• 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-4700 for MERS-CoV in Healthy Volunteers
• Official Title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
• Brief Summary: The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Intervention

• Drug: INO-4700
  INO-4700 will be administered ID.
• Drug: Placebo
  Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
  Other Name: SSC-0001
• Device: CELLECTRA™ 2000
  EP using the CELLECTRA™ 2000 device will be administered following ID drug administration

Study Arms

• Experimental: Part 1: INO-4700 Group A
  Participants will receive one ID injection of 0.6 milligram (mg) of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
  Interventions:

  • Drug: INO-4700
  • Device: CELLECTRA™ 2000
• Experimental: Part 1: INO-4700 Group B
  Participants will receive one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
  Interventions:

  • Drug: INO-4700
  • Device: CELLECTRA™ 2000
• Experimental: Part 1: INO-4700 Group C
  Participants will receive one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
  Interventions:

  • Drug: INO-4700
  • Device: CELLECTRA™ 2000
• Experimental: Part 1: INO-4700 Group D
  Participants will receive two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
  Interventions:

  • Drug: INO-4700
  • Device: CELLECTRA™ 2000
• Experimental: Part 1: INO-4700 Group E
  Participants will receive two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
  Interventions:

  • Drug: INO-4700
  • Device: CELLECTRA™ 2000
• Placebo Comparator: Part 1: Placebo Group F
  Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
  Interventions:

  • Drug: Placebo
  • Device: CELLECTRA™ 2000
• Placebo Comparator: Part 1: Placebo Group G
  Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
  Interventions:

  • Drug: Placebo
  • Device: CELLECTRA™ 2000
• Placebo Comparator: Part 1: Placebo Group H
  Participants will receive two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
  Interventions:

  • Drug: Placebo
  • Device: CELLECTRA™ 2000
• Placebo Comparator: Part 1: Placebo Group I
  Participants will receive two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
  Interventions:

  • Drug: Placebo
  • Device: CELLECTRA™ 2000
• Experimental: Part 2: Parts 2A and 2B
  Participants will receive ID injection of INO-4700 based on optimal dose and regimen selection in Part 1 followed by EP using the CELLECTRA™ 2000 device on Day 0, Week 4 or Week 8 and a booster dose at Week 48 (only for Part 2B participants receiving a third dose).
  Interventions:

  • Drug: INO-4700
  • Device: CELLECTRA™ 2000

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 13, 2020): 542
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 15, 2024
• Estimated Primary Completion Date: June 15, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key 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;
• Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
• Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
• Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose.

Key Exclusion Criteria:

• Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose;
• History of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis;
• Currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
• Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;
• Previous receipt of an investigational vaccine product for the prevention of MERS;
• Prior exposure to MERS-CoV or camels;
• Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2;
• Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
• Prisoner or participants who are compulsorily detained (involuntary incarceration);
• Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic corticosteroids must be discontinued at least 3 months prior to first dose;
• Reported active drug or alcohol or substance abuse or dependence.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Inovio Call Center; (267) 440-4237; clinical.trials@inovio.com

• Listed Location Countries: Jordan, Kenya, Lebanon

Administrative Information

• NCT Number: NCT04588428
• Other Study ID Numbers: MERS-201
• 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
• Product Manufactured in and Exported from the U.S.: 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.

• Current Responsible Party: Inovio Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Inovio Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Coalition for Epidemic Preparedness Innovations

Investigators

• Study Director: Bonaventure Orizu, MD; Inovio Pharmaceuticals

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