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

Primary Purpose

Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

INO-4700

Placebo

CELLECTRA™ 2000

About this trial

This is an interventional prevention trial for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) focused on measuring Healthy, Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
Pharmaceutical Research Center / Jordan University of Science and Technology
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
Ahero Clincal Trials Unit
American University of Beirut Medical Center
Hammoud Hospital University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Part 1: INO-4700 Group A

Part 1: INO-4700 Group B

Part 1: INO-4700 Group C

Part 1: INO-4700 Group D

Part 1: INO-4700 Group E

Part 1: Placebo Group F

Part 1: Placebo Group G

Part 1: Placebo Group H

Part 1: Placebo Group I

Part 2: Parts 2A and 2B

Arm Description

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.

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.

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.

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.

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.

Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.

Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.

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.

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.

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).

Outcomes

Primary Outcome Measures

Frequency of Adverse Events in Part 1

Percentage of Participants with Adverse Events in Part 1

Frequency of Injection Site Reactions in Part 1

Percentage of Participants with Injection Site Reactions in Part 1

Frequency of Adverse Events of Special Interest (AESIs) in Part 1

Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1

Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1

Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1

Percentage Antigen Specific Cellular Immune Response in Part 1

Percentage of Seroconverted Participants in Part 1

Percentage of Participants with Overall Immune Response in Part 1

Frequency of Adverse Events in Part 2

Percentage of Participants with Adverse Events in Part 2

Frequency of Injection Site Reactions in Part 2

Percentage of Participants with Injection Site Reactions in Part 2

Frequency of Adverse Events of Special Interest (AESIs) in Part 2

Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2

Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2

Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2

Percentage Antigen Specific Cellular Immune Response in Part 2

Percentage of Seroconverted Participants in Part 2

Percentage of Participants with Overall Immune Response in Part 2

Secondary Outcome Measures

Full Information

NCT ID

NCT04588428

First Posted

October 6, 2020

Last Updated

January 27, 2023

Sponsor

Inovio Pharmaceuticals

Collaborators

Coalition for Epidemic Preparedness Innovations

1. Study Identification

Unique Protocol Identification Number

NCT04588428

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 21, 2021 (Actual)

Primary Completion Date

January 19, 2023 (Actual)

Study Completion Date

January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inovio Pharmaceuticals

Collaborators

Coalition for Epidemic Preparedness Innovations

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Keywords

Healthy, Coronavirus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part 1: INO-4700 Group A

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: INO-4700 Group B

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: INO-4700 Group C

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: INO-4700 Group D

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: INO-4700 Group E

Arm Type

Experimental

Arm Description

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.

Arm Title

Part 1: Placebo Group F

Arm Type

Placebo Comparator

Arm Description

Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.

Arm Title

Part 1: Placebo Group G

Arm Type

Placebo Comparator

Arm Description

Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.

Arm Title

Part 1: Placebo Group H

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Part 1: Placebo Group I

Arm Type

Placebo Comparator

Arm Description

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.

Arm Title

Part 2: Parts 2A and 2B

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

INO-4700

Intervention Description

INO-4700 will be administered ID.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

SSC-0001

Intervention Description

Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.

Intervention Type

Device

Intervention Name(s)

CELLECTRA™ 2000

Intervention Description

EP using the CELLECTRA™ 2000 device will be administered following ID drug administration

Primary Outcome Measure Information:

Title

Frequency of Adverse Events in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage of Participants with Adverse Events in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Frequency of Injection Site Reactions in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage of Participants with Injection Site Reactions in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Frequency of Adverse Events of Special Interest (AESIs) in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage Antigen Specific Cellular Immune Response in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage of Seroconverted Participants in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Percentage of Participants with Overall Immune Response in Part 1

Time Frame

Part 1: baseline up to Week 48

Title

Frequency of Adverse Events in Part 2

Time Frame