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

Inovio Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Treatments: Drug: INO-4700; Device: CELLECTRA™ 2000; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04588428

MERS-201

Details and patient eligibility

About

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.

Enrollment: 192 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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192 participants in 10 patient groups, including a placebo group

Part 1: INO-4700 Group A

Experimental group

Description:

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.

Treatment:

Drug: INO-4700

Device: CELLECTRA™ 2000

Part 1: INO-4700 Group B

Experimental group

Description:

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.

Treatment:

Drug: INO-4700

Device: CELLECTRA™ 2000

Part 1: INO-4700 Group C

Experimental group

Description:

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.

Treatment:

Drug: INO-4700

Device: CELLECTRA™ 2000

Part 1: INO-4700 Group D

Experimental group

Description:

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.

Treatment:

Drug: INO-4700

Device: CELLECTRA™ 2000

Part 1: INO-4700 Group E

Experimental group

Description:

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.

Treatment:

Drug: INO-4700

Device: CELLECTRA™ 2000

Part 1: Placebo Group F

Placebo Comparator group

Description:

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

Treatment:

Device: CELLECTRA™ 2000

Drug: Placebo

Part 1: Placebo Group G

Placebo Comparator group

Description:

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

Treatment:

Device: CELLECTRA™ 2000

Drug: Placebo

Part 1: Placebo Group H

Placebo Comparator group

Description:

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.

Treatment:

Device: CELLECTRA™ 2000

Drug: Placebo

Part 1: Placebo Group I

Placebo Comparator group

Description:

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.

Treatment:

Device: CELLECTRA™ 2000

Drug: Placebo

Part 2: Parts 2A and 2B

Experimental group

Description:

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).

Treatment:

Drug: INO-4700

Device: CELLECTRA™ 2000