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

Overview

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.

Full Title of Study: “Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 20, 2023

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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 1 month 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 1 month 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 an investigational vaccine product for the prevention of MERS or severe acute respiratory syndrome (SARS); – 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Inovio Pharmaceuticals
  • Collaborator
    • Coalition for Epidemic Preparedness Innovations
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bonaventure Orizu, MD, Study Director, Inovio Pharmaceuticals
  • Overall Contact(s)
    • Inovio Call Center, (267) 440-4237, clinical.trials@inovio.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.