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

Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04588428
• Other study ID #: MERS-201
• Status: Completed
• Phase: Phase 2
• Start date: June 21, 2021
• Est. completion date: January 19, 2023

Study information

• Verified date: January 2024
• Source: Inovio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
• Syndrome

Intervention

Drug:
• INO-4700
INO-4700 was administered ID.
• Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.

Device:
• CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device was administered following ID drug administration

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Inovio Pharmaceuticals	Coalition for Epidemic Preparedness Innovations

Countries where clinical trial is conducted

Jordan,  Kenya,  Lebanon, 

Outcome

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