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Trial details
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Current status:
Approved
|
Date registered:
17/12/2020
|
Date last updated:
15/12/2020
Trial version(s)
History: 28/06/2020
History: 28/06/2020
History: 28/06/2020
History: 28/06/2020
History: 28/06/2020
Current: 28/06/2020
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Main Information
Primary registry identifying number
LBCTR2020113522
Protocol number
MERS-201
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
A Phase 1 clinical trial evaluating GLS-5300 (which is the same product as INO-4700) has previously been conducted in the United States at Walter Reed Medical Center (clinicaltrials.gov NCT02670187). Additionally, ongoing evaluation in a Phase 1/2a clinical trial is being conducted at two centers in South Korea (clinicaltrials.gov NCT03721718). The MERS-201 clinical trial will not be filed under an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA). The Middle East and Africa have been selected to advance the MERS-201 clinical trial in a demographically relevant population.
Type of registration
Prospective
Date of registration in national regulatory agency
28/06/2020
Primary sponsor
Inovio Pharmaceuticals, Inc.
Primary sponsor: Country of origin
USA
Public title
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Acronym
MERS-201
Scientific title
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Acronym
MERS-201
Brief summary of the study: English
The purpose of this program is to evaluate the safety, tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Brief summary of the study: Arabic
دراسة لتقييم السلامة ودرجة التحمل والاستمناع لعقار INO-4700 لعلاج فيروس كورونا المرتبط بمتلازمة الشرق الأوسط التنفسية (MERS-CoV) لدى المتطوعين الأصحاء
Health conditions/problem studied: Specify
NA (Healthy Volunteers)
Interventions: Specify
-In Part 1, approximately 192 participants ages 18-50 years will be assessed through five (5) dose levels and regimens. These five (5) dose levels and regimens will be evaluated across nine (9) groups designated Study Groups A, B, C, D, E, F, G, H and I. Study Groups A, B, C, D and E will receive INO-4700 and enroll approximately 32 participants per group. Study Groups F, G, H and I will receive placebo and enroll approximately 8 participants per group. Participants will receive either one or two injections of INO-4700 or Placebo at weeks 0 and 4 or weeks 0 and 8. Upon completion of the Week 10 visit and availability of immunological data, Part 1 will be unblinded in order to allow for one regimen to be selected for advancement into Part 2. The Study Group with an optimal immune response, an acceptable safety profile and tolerant dosing regimen by Week 10, will be selected for Part 2. -In Part 2 – Expansion In Part 2A, participants will be randomized to receive the optimal dose and regimen of active (INO-4700) selected in Part 1 or placebo (SSC-0001). Approximately 300 participants will receive INO-4700 and 50 participants will receive placebo. In Part 2B, the first 200 participants randomized to the Part 2A Active Study Group will receive a third dose of either INO-4700 or placebo at Week 48. Similarly, in Part 2B, the first 25 participants randomized to the Part 2A Placebo Study Group will receive a third dose of placebo at Week 48. -Dosage Regimen: Part 1 Group A – One 0.6 mg ID injection of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) Part 1 Group B – One 1.0 mg ID injection of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) Part 1 Group C – One 1.0 mg ID injection of INO-4700 followed by EP administered at Day 0 and Week 8 (± 5 days) Part 1 Group D – Two 0.5 mg ID injections (in an acceptable location on two different limbs) of INO-4700 followed by EP administered at Day 0 and Week 8 (± 5 days) Part 1 Group E – Two 1.0 mg ID injections (in an acceptable location on two different limbs) of INO-4700 followed by EP administered at Day 0 and Week 4 (± 5 days) Part 1 Group F – One ID injection of placebo followed by EP administered at Day 0 and Week 4 (± 5 days) Part 1 Group G – One ID injection of placebo followed by EP administered at Day 0 and Week 8 (± 5 days) Part 1 Group H – Two ID injections (in an acceptable location on two different limbs) of placebo followed by EP administered at Day 0 and Week 8 (± 5 days) Part 1 Group I – Two ID injections (in an acceptable location on two different limbs) of placebo followed by EP administered at Day 0 and Week 4 (± 5 days) Part 2 – Dose and regimen to be determined, each ID injection(s) followed by EP administered at Day 0, Week 4 or Week 8, and Week 48 (for Part 2B participants receiving a third dose) -After each injection, the CELLECTRA (TM) 2000 device will be used to enhance the uptake and expression of the DNA plasmid (INO-4700) in order to enhance vaccine immunogenicity.
Key inclusion and exclusion criteria: Inclusion criteria
a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures; b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years of age; c. Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening. Note: Participants taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose, as defined by non-change in dose for the 3 months prior to the first dose of study medication and no planned changes during the active dosing period of the study; d. Able and willing to comply with all study procedures; e. Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator; f. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening; g. Screening ECG deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome); h. Must meet one of the following criteria with respect to reproductive capacity: Women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months; Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at least six (6) months prior to enrollment or tubal ligation, absence of ovaries and/or uterus in females); Use of 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 inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
100
Key inclusion and exclusion criteria: Exclusion criteria
a. 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; b. Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing; c. History of respiratory diseases such as asthma, chronic obstructive pulmonary disease or chronic bronchitis; d. Is currently participating in or has participated in a study with an investigational product with 30 days preceding Day 0; e. Previous receipt of an investigational vaccine product for prevention of MERS or SARS; f. Prior exposure to MERS-CoV or camels (serology or antibody testing will be requested at the Investigator’s discretion); g. Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 Part 2; h. Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites: Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site; Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a lifethreatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist); Any metal implants or implantable medical device within the electroporation site; i. Prisoner or participants who are compulsorily detained (involuntary incarceration); j. 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; k. Reported active drug or alcohol or substance abuse or dependence.
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Other
Trial scope: Specify scope
2 Part study: Safety, Dose Response and Immunogenicity
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Placebo
Study phase
2
Study design: Purpose
Prevention
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
INO-4700
Type of IMP
Others
Type of IMP: Specify
DNA Vaccine
Pharmaceutical class
DNA Vaccines followed Electroporation (CELLECTRA (TM) 2000)
Therapeutic indication
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Therapeutic benefit
There may be potential benefit for prevention of MERS infection in affected areas. The CELLECTRATM 2000 device is indicated to enhance the uptake and expression of DNA plasmid-based biologics in order to enhance vaccine immunogenicity.
Biospecimen retention
Samples without DNA
Biospecimen description
Whole blood and serum samples will be obtained to assess overall immune response. Details of the immunology sample collection and shipment information will be provided in the Laboratory Manual. The T and B cell immune responses to INO-4700 will be measured using assays that include but are not limited to ELISA, neutralization, assessment of immunological gene expression, assessment of immunological protein expression, flow cytometry and ELISPOT.
Target sample size
542
Actual enrollment target size
542
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
19/10/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
31/10/2023
Recruitment status
Pending
Date of completion
IPD sharing statement plan
Yes
IPD sharing statement description
Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request. Supporting Information includes the Study Protocol and Informed Consent Form (ICF). 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. 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.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
NA
NA
Sources of Monetary or Material Support
Name
Inovio Pharmaceuticals, Inc.
Coalition for Epidemic Preparedness Innovations (CEPI)
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Aziz
Zoghbi
MCT-CRO, Berytech Technology and Health, 5th Floor Damascus Road, Beirut, Lebanon
Lebanon
+9611612 500
zog_az@mct-cro.com
Director of Country Oversight and Management Africa, Levant and GCC
Scientific
Mammen
Mammen
US, Plymouth Meeting
United States of America
001 301-305-4487
mammen.mammen@inovio.com
Senior Vice President, Clinical Development
Public
Inovio Call Center
N/A
NA
United States of America
001 (267) 440-4237
clinical.trials@inovio.com
Inovio call Center
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hammoud Hospital University Medical Center
Dr. Georges Fhaily
Emergency Doctor
Approved
American University of Beirut Medical Center
Dr. Zeina Kanafani
Infectious Disease
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hammoud Hospital University Medical Center
22/09/2020
Mrs. Ghada Aoun
medical@hammoudhospital.org
00961 7 721021
American University of Beirut Medical Center
23/11/2020
Ms. Abir Dakik
ad17@aub.edu.lb
00961 1 340460
Countries of Recruitment
Name
Lebanon
Jordan
Saudi Arabia
Kenya
Health Conditions or Problems Studied
Condition
Code
Keyword
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Vaccine or biological substance, unspecified (Y59.9)
Healthy Coronavirus
Interventions
Intervention
Description
Keyword
INO-4700
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
INO-4700
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
INO-4700
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
INO-4700
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
INO-4700
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 (SSC-0001) Sterile saline sodium citrate buffer
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 (SSC-0001) Sterile saline sodium citrate buffer
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 (SSC-0001) Sterile saline sodium citrate buffer
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 (SSC-0001) Sterile saline sodium citrate buffer
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
INO-4700
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
Primary Outcomes
Name
Time points
Measure
Tolerability and safety of INO-4700 administered by ID injection
Duration of both parts 1 (up to week 48) and 2 (up to week 68) of the study
Incidence of Adverse Events, Number and severity of injection site reactions, Incidence of Adverse Events of Special Interest
Cellular (T Cell) and Humoral immune response to INO-4700 administered by ID injection to select the optimal dose and regimen
Part 1: Week 10.
MERS-CoV antigen specific antibodies, Antigen specific cytokine producing T cell responses
Safety and immunogenicity of selected optimal dose
Part 2: up to week 68
MERS-CoV antigen specific antibodies, Antigen specific cytokine producing T cell responses, Incidence of Adverse Events, Number and severity of injection site reactions, Incidence of Adverse Events of Special Interest
Key Secondary Outcomes
Name
Time points
Measure
NA
NA
NA
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial