Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
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
- 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.
Most Recent Events
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 |
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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
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Mammen P. Mammen, Jr., MD, FACP, FIDSA | Inovio Pharmaceuticals |
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Centres
Centre Name | Location | Trial Centre Country |
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- |
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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 |
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Hammoud Hospital University Medical Center | Saida | Lebanon |
Inovio Pharmaceuticals |
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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
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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 -
Inovio Pharmaceuticals. Inovio's Positive First-in-Human MERS Vaccine Results Published in The Lancet Infectious Diseases. Media-Rel 2019;.
Media Release -
Inovio Pharmaceuticals. Inovio Doses 1st Subject in Phase 1/2 Clinical Trial For Vaccine Against Deadly MERS Infection. Media-Rel 2018;.
Media Release -
Inovio Pharmaceuticals. Inovio Provides Update on Clinical Program Plans for 2020. Media-Rel 2020;.
Media Release -
Inovio Pharmaceuticals. Inovio Pharmaceuticals Reports 2018 Fourth Quarter and Year-End Financial Results. Media-Rel 2019;.
Media Release -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Inovio Pharmaceuticals. INOVIO Reports Fourth Quarter 2021 and Year-End Financial Results. Media-Rel 2022;.
Media Release -
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
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