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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588428
Recruitment Status : Completed
First Posted : October 19, 2020
Last Update Posted : January 30, 2023
Sponsor:
Collaborator:
Coalition for Epidemic Preparedness Innovations
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Drug: INO-4700 Drug: Placebo Device: CELLECTRA™ 2000 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Actual Study Start Date : June 21, 2021
Actual Primary Completion Date : January 19, 2023
Actual Study Completion Date : January 19, 2023
Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: INO-4700
INO-4700 will be administered ID.

Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
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.
 Drug: INO-4700
INO-4700 will be administered ID.

Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
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.
 Drug: INO-4700
INO-4700 will be administered ID.

Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
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.
 Drug: INO-4700
INO-4700 will be administered ID.

Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
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.
 Drug: INO-4700
INO-4700 will be administered ID.

Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
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.
 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
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.
 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
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.
 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
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.
 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
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).
 Drug: INO-4700
INO-4700 will be administered ID.

Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of Adverse Events in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  2. Percentage of Participants with Adverse Events in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  3. Frequency of Injection Site Reactions in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  4. Percentage of Participants with Injection Site Reactions in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  5. Frequency of Adverse Events of Special Interest (AESIs) in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  6. Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  7. Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  8. Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  9. Percentage Antigen Specific Cellular Immune Response in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  10. Percentage of Seroconverted Participants in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  11. Percentage of Participants with Overall Immune Response in Part 1 [ Time Frame: Part 1: baseline up to Week 48 ]
  12. Frequency of Adverse Events in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  13. Percentage of Participants with Adverse Events in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  14. Frequency of Injection Site Reactions in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  15. Percentage of Participants with Injection Site Reactions in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  16. Frequency of Adverse Events of Special Interest (AESIs) in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  17. Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  18. Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  19. Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  20. Percentage Antigen Specific Cellular Immune Response in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  21. Percentage of Seroconverted Participants in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]
  22. Percentage of Participants with Overall Immune Response in Part 2 [ Time Frame: Part 2: baseline up to Week 68 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588428


Locations
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Jordan
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
Irbid, Jordan, 21110
Pharmaceutical Research Center / Jordan University of Science and Technology
Irbid, Jordan, 22110
Kenya
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
Kericho, Kenya, 20200
Ahero Clincal Trials Unit
Kisumu, Kenya, 40100
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Sponsors and Collaborators
Inovio Pharmaceuticals
Coalition for Epidemic Preparedness Innovations
Investigators
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Study Director: Bonaventure Orizu, MD Inovio Pharmaceuticals
More Information
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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04588428    
Other Study ID Numbers: MERS-201
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (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
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.

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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
Keywords provided by Inovio Pharmaceuticals:
Healthy
Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Virus Diseases
Infections