Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
• Intervention / Treatment: Drug: INO-4700; Device: CELLECTRA™ 2000; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 2

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan, 21110
    • Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
  • Irbid, Jordan, 22110
    • Pharmaceutical Research Center / Jordan University of Science and Technology
• Kenya
  • Kericho, Kenya, 20200
    • Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
  • Kisumu, Kenya, 40100
    • Ahero Clincal Trials Unit
• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center
  • Saida, Lebanon
    • Hammoud Hospital University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Experimental: 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
Placebo Comparator: 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.	Device: CELLECTRA™ 2000; EP using the CELLECTRA™ 2000 device was administered following ID drug administration; Drug: Placebo; Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.; Other Names: SSC-0001
Placebo Comparator: 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.	Device: CELLECTRA™ 2000; EP using the CELLECTRA™ 2000 device was administered following ID drug administration; Drug: Placebo; Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.; Other Names: SSC-0001
Placebo Comparator: 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.	Device: CELLECTRA™ 2000; EP using the CELLECTRA™ 2000 device was administered following ID drug administration; Drug: Placebo; Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.; Other Names: SSC-0001
Placebo Comparator: 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.	Device: CELLECTRA™ 2000; EP using the CELLECTRA™ 2000 device was administered following ID drug administration; Drug: Placebo; Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.; Other Names: SSC-0001
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of Adverse Events in Part 1	Part 1: baseline up to Week 48
Percentage of Participants with Adverse Events in Part 1	Part 1: baseline up to Week 48
Frequency of Injection Site Reactions in Part 1	Part 1: baseline up to Week 48
Percentage of Participants with Injection Site Reactions in Part 1	Part 1: baseline up to Week 48
Frequency of Adverse Events of Special Interest (AESIs) in Part 1	Part 1: baseline up to Week 48
Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1	Part 1: baseline up to Week 48
Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1	Part 1: baseline up to Week 48
Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1	Part 1: baseline up to Week 48
Percentage Antigen Specific Cellular Immune Response in Part 1	Part 1: baseline up to Week 48
Percentage of Seroconverted Participants in Part 1	Part 1: baseline up to Week 48
Percentage of Participants with Overall Immune Response in Part 1	Part 1: baseline up to Week 48
Frequency of Adverse Events in Part 2	Part 2: baseline up to Week 68
Percentage of Participants with Adverse Events in Part 2	Part 2: baseline up to Week 68
Frequency of Injection Site Reactions in Part 2	Part 2: baseline up to Week 68
Percentage of Participants with Injection Site Reactions in Part 2	Part 2: baseline up to Week 68
Frequency of Adverse Events of Special Interest (AESIs) in Part 2	Part 2: baseline up to Week 68
Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2	Part 2: baseline up to Week 68
Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2	Part 2: baseline up to Week 68
Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2	Part 2: baseline up to Week 68
Percentage Antigen Specific Cellular Immune Response in Part 2	Part 2: baseline up to Week 68
Percentage of Seroconverted Participants in Part 2	Part 2: baseline up to Week 68
Percentage of Participants with Overall Immune Response in Part 2	Part 2: baseline up to Week 68

Collaborators and Investigators

• Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations
• Investigators: Study Director: Bonaventure Orizu, MD, Inovio Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 13, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Healthy; Coronavirus
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease; Coronavirus Infections; Syndrome
• Other Study ID Numbers: MERS-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes