Clinical trial NCT04588428: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Keywords: Healthy
Coronavirus
Lead sponsor: Inovio Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Coalition for Epidemic Preparedness Innovations
First posted: 2020-10-19
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Frequency of Adverse Events in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage of Participants with Adverse Events in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Frequency of Injection Site Reactions in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage of Participants with Injection Site Reactions in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Frequency of Adverse Events of Special Interest (AESIs) in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage Antigen Specific Cellular Immune Response in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage of Seroconverted Participants in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Percentage of Participants with Overall Immune Response in Part 1
timeFrame: Part 1: baseline up to Week 48
measure: Frequency of Adverse Events in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage of Participants with Adverse Events in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Frequency of Injection Site Reactions in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage of Participants with Injection Site Reactions in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Frequency of Adverse Events of Special Interest (AESIs) in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage Antigen Specific Cellular Immune Response in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage of Seroconverted Participants in Part 2
timeFrame: Part 2: baseline up to Week 68
measure: Percentage of Participants with Overall Immune Response in Part 2
timeFrame: Part 2: baseline up to Week 68
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
city: Irbid
country: Jordan
facility: Pharmaceutical Research Center / Jordan University of Science and Technology
city: Kericho
country: Kenya
facility: Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
city: Kisumu
country: Kenya
facility: Ahero Clincal Trials Unit
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
Study officials:
affiliation: Inovio Pharmaceuticals
name: Bonaventure Orizu, MD
role: STUDY_DIRECTOR
References: