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History of Changes for Study: NCT04588428
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Latest version (submitted June 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 13, 2020 None (earliest Version on record)
2 November 17, 2020 Study Status and Contacts/Locations
3 December 11, 2020 Study Status
4 January 18, 2021 Study Status
5 February 1, 2021 Study Status and Contacts/Locations
6 February 18, 2021 Study Status
7 March 18, 2021 Study Status
8 April 16, 2021 Study Status
9 May 28, 2021 Recruitment Status, Study Status, Contacts/Locations and Eligibility
10 June 21, 2021 Study Status and Contacts/Locations
11 July 16, 2021 Study Status and Contacts/Locations
12 August 18, 2021 Study Status
13 September 16, 2021 Study Status and Contacts/Locations
14 October 18, 2021 Study Status and Contacts/Locations
15 November 18, 2021 Study Status
16 December 17, 2021 Study Status and Contacts/Locations
17 January 18, 2022 Study Status
18 February 18, 2022 Study Status
19 March 18, 2022 Study Status
20 April 18, 2022 Study Status
21 May 18, 2022 Study Status
22 June 16, 2022 Study Status
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Study NCT04588428
Submitted Date:  January 18, 2021 (v4)

Open or close this module Study Identification
Unique Protocol ID: MERS-201
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2021
Overall Status: Not yet recruiting
Study Start: February 26, 2021
Primary Completion: September 20, 2023 [Anticipated]
Study Completion: September 20, 2023 [Anticipated]
First Submitted: October 6, 2020
First Submitted that
Met QC Criteria:
October 13, 2020
First Posted: October 19, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
January 18, 2021
Last Update Posted: January 20, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Inovio Pharmaceuticals
Responsible Party: Sponsor
Collaborators: Coalition for Epidemic Preparedness Innovations
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Keywords: Healthy
Coronavirus
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 10
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 542 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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 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.
Open or close this module Contacts/Locations
Central Contact Person: Inovio Call Center
Telephone: (267) 440-4237
Email: clinical.trials@inovio.com
Study Officials: Mammen P. Mammen, Jr., MD, FACP, FIDSA
Study Director
Inovio Pharmaceuticals
Locations: Jordan
Pharmaceutical Research Center / Jordan University of Science and Technology
Irbid, Jordan, 22110
Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Hammoud Hospital University Medical Center
Saida, Lebanon
Open or close this module IPDSharing
Plan to Share IPD: Yes
Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Information:
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.
URL:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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