Phase 2
N=192
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Bottom Line
View on ClinicalTrials.gov: NCT04588428 ↗Enrolled (actual)
192
Serious AEs
1.0%
Results posted
Jan 2026
Primary outcome: Primary: Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs — 34.4; 30.3; 43.8; 31.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- INO-4700 (Drug); Placebo (Drug); CELLECTRA™ 2000 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inovio Pharmaceuticals
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs |
34.4; 30.3; 43.8; 31.3; 41.9; 25.0 | — |
| PRIMARY Part 1: Percentage of Participants With Injection Site Reactions |
0; 0; 0; 3.1; 0; 0 | — |
| PRIMARY Part 1: Percentage of Participants With Adverse Events of Special Interest (AESIs) |
0; 6.1; 3.1; 0; 6.5; 0 | — |
| PRIMARY Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 6 |
4.30; 3.81; 2.29; 3.05; 8.11; 2.37 | — |
| PRIMARY Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 6 |
1.93; 2.04; 1.24; 1.40; 3.20; 1.10 | — |
| PRIMARY Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 10 |
5.07; 6.68; 3.49; 7.33; 11.92; 1.99 | — |
| PRIMARY Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 10 |
2.31; 3.60; 1.88; 3.38; 4.69; 0.94 | — |
| PRIMARY Part 1: Percentage Neutralizing Antibody Responders at Week 6 |
12.50; 12.90; 6.25; 6.25; 12.90; 0 | — |
| PRIMARY Part 1: Percentage Neutralizing Antibody Responders at Week 10 |
15.63; 10.00; 9.09; 15.63; 12.90; 14.29 | — |
| PRIMARY Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 6 |
14.29; 11.54; 0; 3.70; 24.00; 0 | — |
| PRIMARY Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 10 |
6.45; 7.41; 23.08; 24.14; 17.24; 0 | — |
| PRIMARY Part 2: Percentage of Participants With Adverse Events |
— | — |
| PRIMARY Part 2: Percentage of Participants With Injection Site Reactions |
— | — |
| PRIMARY Part 2: Percentage of Participants With Adverse Events of Special Interest (AESIs) |
— | — |
| PRIMARY Part 2: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody |
— | — |
| PRIMARY Part 2: Percentage Neutralizing Antibody Responders |
— | — |
| PRIMARY Part 2: Percentage of Antigen Specific Cellular Immune Responders |
— | — |
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 was 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.
Data sourced from ClinicalTrials.gov (NCT04588428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.