Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Phase 2
Completed
- Conditions
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
- Interventions
- Registration Number
- NCT04588428
- Lead Sponsor
- Inovio Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: INO-4700 Group A INO-4700 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. Part 1: INO-4700 Group C INO-4700 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. Part 1: INO-4700 Group E INO-4700 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. Part 1: INO-4700 Group C CELLECTRA™ 2000 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. Part 1: Placebo Group G Placebo Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8. Part 1: Placebo Group H Placebo 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. Part 2: Parts 2A and 2B INO-4700 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). Part 1: Placebo Group I CELLECTRA™ 2000 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. Part 1: INO-4700 Group A CELLECTRA™ 2000 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. Part 1: INO-4700 Group B CELLECTRA™ 2000 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. Part 1: Placebo Group F Placebo Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4. Part 1: Placebo Group F CELLECTRA™ 2000 Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4. Part 1: INO-4700 Group D CELLECTRA™ 2000 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. Part 1: INO-4700 Group E CELLECTRA™ 2000 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. Part 1: Placebo Group H CELLECTRA™ 2000 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. Part 1: Placebo Group I Placebo 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. Part 1: Placebo Group G CELLECTRA™ 2000 Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8. Part 2: Parts 2A and 2B CELLECTRA™ 2000 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). Part 1: INO-4700 Group B INO-4700 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. Part 1: INO-4700 Group D INO-4700 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2 Part 2: baseline up to Week 68 Frequency of 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 MERS-CoV Antigen Specific Neutralizing Antibodies 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 Injection Site Reactions 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 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 Seroconverted Participants in Part 2 Part 2: baseline up to Week 68 Frequency of Adverse Events of Special Interest (AESIs) in Part 1 Part 1: baseline up to Week 48 Percentage of Participants with Injection Site Reactions 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 Participants with Overall Immune Response in Part 2 Part 2: baseline up to Week 68 Percentage of Participants with Adverse Events 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 Antigen Specific Cellular 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 MERS-CoV Antigen Specific Neutralizing Antibodies 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 Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2 Part 2: baseline up to Week 68
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
🇯🇴Irbid, Jordan
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
🇰🇪Kericho, Kenya
Pharmaceutical Research Center / Jordan University of Science and Technology
🇯🇴Irbid, Jordan
Ahero Clincal Trials Unit
🇰🇪Kisumu, Kenya
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon
Hammoud Hospital University Medical Center
🇱🇧Saida, Lebanon