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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588428
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : July 19, 2022
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 6, 2020
First Posted Date  ICMJE October 19, 2020
Last Update Posted Date July 19, 2022
Actual Study Start Date  ICMJE June 21, 2021
Estimated Primary Completion Date June 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 13, 2020)
542
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2024
Estimated Primary Completion Date June 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Inovio Call Center (267) 440-4237 clinical.trials@inovio.com
Listed Location Countries  ICMJE Jordan,   Kenya,   Lebanon
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04588428
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Inovio Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Coalition for Epidemic Preparedness Innovations
Investigators  ICMJE
Study Director: Bonaventure Orizu, MD Inovio Pharmaceuticals
PRS Account Inovio Pharmaceuticals
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP