Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Trial Profile

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jan 2024

At a glance

  • Drugs GLS 5300 (Primary)
  • Indications Middle East respiratory syndrome coronavirus
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Inovio Pharmaceuticals
  • Most Recent Events

    • 22 Dec 2022 Status changed from active, no longer recruiting to completed.
    • 18 Nov 2022 Planned End Date changed from 15 Jun 2024 to 24 Nov 2022.
    • 18 Nov 2022 Planned primary completion date changed from 15 Jun 2024 to 24 Nov 2022.

Trial Overview

Purpose

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.

Primary Endpoints

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
primary_outcome

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
primary_outcome

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

Diseases Treated

Indication Qualifiers Patient Segments
Middle East respiratory syndrome coronavirus prevention -

Subjects

  • Subject Type patients
  • Number

    Planned: 542

    Actual: 192

  • Sex male & female
  • Age Group ≥ 18 years; adult

Patient Inclusion Criteria

Key - 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

Patient 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.

Trial Details

Identifiers

Identifier Owner
NCT04588428 ClinicalTrials.gov: US National Institutes of Health
MERS201 -

Organisations

  • Sponsors Inovio Pharmaceuticals
  • Affiliations Inovio Pharmaceuticals

Trial Dates

  • Initiation Dates

    Planned : 30 Apr 2021

    Actual : 21 Jun 2021

  • Primary Completion Dates

    Planned : 24 Nov 2022

    Actual : 19 Jan 2023

  • End Dates

    Planned : 24 Nov 2022

    Actual : 19 Jan 2023

Other Details

  • Design double-blind; multicentre; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location Jordan; Kenya; Lebanon
  • Focus Adverse reactions; Pharmacodynamics

Interventions

Drugs Route Formulation
GLS 5300Primary Drug Intradermal Injection

Part 1: INO-4700 Group A

Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRA™ 2000 device on Day 0 and Week 4. Drug: INO-4700 (INO-4700 was administered ID.) Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: INO-4700 Group B

Participants received 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 was administered ID.) Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: INO-4700 Group C

Participants received 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 was administered ID.) Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: INO-4700 Group D

Participants received 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 was administered ID.) Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: INO-4700 Group E

Participants received 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 was administered ID.) Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 2: Parts 2A and 2B

Participants were planned to 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 were planned to receive a third dose). Drug: INO-4700 (INO-4700 was administered ID.) Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: Placebo Group F

Participants received 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) was administered ID.) Other Name: SSC-0001 Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: Placebo Group G

Participants received 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) was administered ID.) Other Name: SSC-0001 Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: Placebo Group H

Participants received 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) was administered ID.) Other Name: SSC-0001 Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Part 1: Placebo Group I

Participants received 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) was administered ID.) Other Name: SSC-0001 Device: CELLECTRA™ 2000 (EP using the CELLECTRA™ 2000 device was administered following ID drug administration)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Inovio Call Center
(267) 440-4237 clinical.trials@inovio.com
show details
-
Mammen P. Mammen, Jr., MD, FACP, FIDSA Inovio Pharmaceuticals
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Ahero Clincal Trials Unit Kisumu Kenya
American University of Beirut Medical Center Beirut Lebanon
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH) Irbid Jordan
Coalition for Epidemic Preparedness Innovations
-
-
Hammoud Hospital University Medical Center Saida Lebanon
Inovio Pharmaceuticals
-
-
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP) Kericho Kenya
Pharmaceutical Research Center / Jordan University of Science and Technology Irbid Jordan

Trial History

Event Date Event Type Comment
22 Jan 2024 Other trial event Last checked against ClinicalTrials.gov record. Updated 22 Jan 2024
22 Dec 2022 Status change - completed Status changed from active, no longer recruiting to completed. Updated 29 Dec 2022
18 Nov 2022 Completion date Planned End Date changed from 15 Jun 2024 to 24 Nov 2022. Updated 23 Nov 2022
18 Nov 2022 Other trial event Planned primary completion date changed from 15 Jun 2024 to 24 Nov 2022. Updated 23 Nov 2022
18 Nov 2022 Status change - active, no longer recruiting Status changed from recruiting to active, no longer recruiting. Updated 23 Nov 2022
01 Mar 2022 Other trial event According to an Inovio Pharmaceuticals media release, company has dosed and completed enrollment for the first part (dose finding stage) of the Phase 2 trial (192 participants) Updated 08 Mar 2022
18 Aug 2021 Completion date Planned End Date changed from 20 Sep 2023 to 15 Jun 2024. Updated 24 Aug 2021
18 Aug 2021 Other trial event Planned primary completion date changed from 20 Sep 2023 to 15 Jun 2024. Updated 24 Aug 2021
04 Aug 2021 Other trial event According to a Regeneron Pharmaceuticals media release, first subject has been dosed in this study. Updated 11 Aug 2021
28 May 2021 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 07 Jun 2021
16 Apr 2021 Other trial event Planned initiation date changed from 15 Apr 2021 to 30 Apr 2021. Updated 20 Apr 2021
18 Mar 2021 Other trial event Planned initiation date changed from 26 Feb 2021 to 15 Apr 2021. Updated 23 Mar 2021
18 Jan 2021 Other trial event Planned initiation date changed from 29 Jan 2021 to 26 Feb 2021. Updated 21 Jan 2021
11 Dec 2020 Completion date Planned End Date changed from 30 Jul 2023 to 20 Sep 2023. Updated 16 Dec 2020
11 Dec 2020 Other trial event Planned primary completion date changed from 30 Jul 2023 to 20 Sep 2023. Updated 16 Dec 2020
11 Dec 2020 Other trial event Planned initiation date changed from 11 Dec 2020 to 29 Jan 2021. Updated 16 Dec 2020
17 Nov 2020 Other trial event Planned initiation date changed from 30 Nov 2020 to 11 Dec 2020. Updated 20 Nov 2020
23 Oct 2020 Other trial event New source identified and integrated (ClinicalTrial.gov: NCT04588428) Updated 23 Oct 2020
13 Oct 2020 Status change - not yet recruiting Status changed from planning to not yet recruiting. Updated 23 Oct 2020
28 Apr 2020 Other trial event According to an Inovio Pharmaceuticals media release, the Coalition for Epidemic Preparedness Innovations (CEPI) has provided funding of $56 million for this trial. Updated 30 Apr 2020
06 Jan 2020 Other trial event According to an Inovio Pharmaceuticals media release, the company expects to initiate this trial in 2020. Updated 07 Jan 2020
25 Jul 2019 Other trial event According to an Inovio Pharmaceuticals media release, the company is planning this trial based on the data of previous Phase 1b/2a trial(CTP 700288728). Updated 29 Jul 2019
18 Mar 2019 New trial record New trial record Updated 18 Mar 2019
12 Mar 2019 Other trial event According to a Inovio Pharmaceuticals media release, this trial is expected to commence in the second half of 2019. Updated 18 Mar 2019
05 Sep 2018 Other trial event According to a Inovio Pharmaceuticals media release, CEPI will be funding this trial. This trial is expected to commence in 2019. Updated 18 Mar 2019

References

  1. Inovio Pharmaceuticals. INOVIO Doses First Participant in Phase 2 Trial for its DNA Vaccine Against Middle East Respiratory Syndrome (MERS), a Coronavirus Disease. Media-Rel 2021;.

    Media Release
  2. Inovio Pharmaceuticals. Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases. Media-Rel 2019;.

    Media Release
  3. Inovio Pharmaceuticals. Inovio Doses 1st Subject in Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection. Media-Rel 2018;.

    Media Release
  4. Inovio Pharmaceuticals. Inovio Provides Update on Clinical Program Plans for 2020. Media-Rel 2020;.

    Media Release
  5. Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2018 Fourth Quarter and Year-End Financial Results. Media-Rel 2019;.

    Media Release
  6. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.

    Available from: URL: http://clinicaltrials.gov
  7. Inovio Pharmaceuticals. INOVIO Reports Fourth Quarter 2021 and Year-End Financial Results. Media-Rel 2022;.

    Media Release
  8. Inovio Pharmaceuticals. INOVIO and GeneOne Life Science Report Positive Phase 1/2a Clinical Data With DNA Vaccine INO-4700 for MERS Coronavirus at the American Society of Gene & Cell Therapy (ASGCT) Conference. Media-Rel 2020;.

    Media Release
Back to top