Middle East Respiratory Syndrome Coronavirus (MERS-CoV)Phase 2NCT04588428
Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
A Phase 2 study testing INO-4700 and CELLECTRA™ 2000 in people with Middle East Respiratory Syndrome Coronavirus (MERS-CoV), run by Inovio Pharmaceuticals at 6 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
- What is being tested?
- INO-4700 and CELLECTRA™ 2000
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 21 Jun 2021to 19 Jan 2023
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Jordan2 sites
Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
Irbid, 21110
Pharmaceutical Research Center / Jordan University of Science and Technology
Irbid, 22110
Kenya2 sites
Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
Kericho, 20200
Ahero Clincal Trials Unit
Kisumu, 40100
Lebanon2 sites
American University of Beirut Medical Center
Beirut
Hammoud Hospital University Medical Center
Saida
About this study
Official title: Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
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.
- Being tested
- INO-4700, Placebo, CELLECTRA™ 2000
- Keywords
- Healthy, Coronavirus
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-4700Drug
INO-4700 was administered ID.
PlaceboDrug
Also called SSC-0001
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID.
CELLECTRA™ 2000Device
EP using the CELLECTRA™ 2000 device was administered following ID drug administration
INO-4700Drug
INO-4700
CELLECTRA™ 2000Device
CELLECTRA™ 2000
| Study group | Role | What they receive |
|---|---|---|
| Part 1: INO-4700 Group A | Experimental | 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. Receives: Drug: INO-4700; Device: CELLECTRA™ 2000 |
| Part 1: INO-4700 Group B | Experimental | 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. Receives: Drug: INO-4700; Device: CELLECTRA™ 2000 |
| Part 1: INO-4700 Group C | Experimental | 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. Receives: Drug: INO-4700; Device: CELLECTRA™ 2000 |
| Part 1: INO-4700 Group D | Experimental | 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. Receives: Drug: INO-4700; Device: CELLECTRA™ 2000 |
| Part 1: INO-4700 Group E | Experimental | 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. Receives: Drug: INO-4700; Device: CELLECTRA™ 2000 |
| Part 1: Placebo Group F | Placebo comparator | Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4. Receives: Drug: Placebo; Device: CELLECTRA™ 2000 |
| Part 1: Placebo Group G | Placebo comparator | Participants received one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8. Receives: Drug: Placebo; Device: CELLECTRA™ 2000 |
| Part 1: Placebo Group H | Placebo comparator | 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. Receives: Drug: Placebo; Device: CELLECTRA™ 2000 |
| Part 1: Placebo Group I | Placebo comparator | 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. Receives: Drug: Placebo; Device: CELLECTRA™ 2000 |
| Part 2: Parts 2A and 2B | Experimental | 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). Receives: Drug: INO-4700; Device: CELLECTRA™ 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with treatment. TEAEs: AEs with onset after administration of study medication through the end of the study, or any event that was present at baseline but worsened in intensity or was subsequently considered drug-related by the Investigator through the end of the study. TEAEs were graded based on the Toxicity Grading Scale for Healthy Adult \& Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Food and Drug Administration [FDA] Guidance for Industry), as Grade 1: No interference with activity, Grade 2: Some interference with activity, Grade 3: Prevents daily activity/requires medical intervention \& Grade 4: Emergency room visit/hospitalization. A causally related AE is one judged by the Investigator to have a possible, probable, or definite relationship to the administration of an investigational product (IP).
Measured: From the first dose of the study drug up to the end of the study (up to 48.7 weeks)
Part 1: Percentage of Participants With Injection Site Reactions
Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' FDA Guidance for Industry, September 2007. Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection.
Measured: From the first dose of the study drug up to the end of the study (up to 48.7 weeks)
Part 1: Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Principal Investigator to the Sponsor can be appropriate.
Measured: From Screening to the end of the study (up to 48.7 weeks)
Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 6
Whole blood and serum samples were collected for the cellular immunology assessment. MERS receptor binding domain (RBD) immunoglobulin G (IgG) concentrations in response to administration of INO-4700 in combination with EP were reported as the GMC.
Measured: At Week 6
Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 6
Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMFR.
Measured: At Week 6
Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 10
Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMC.
Measured: At Week 10
Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 10
Whole blood and serum samples were collected for the cellular immunology assessment. MERS RBD IgG concentrations in response to administration of INO-4700 in combination with EP were reported as the GMFR.
Measured: At Week 10
Part 1: Percentage Neutralizing Antibody Responders at Week 6
The immune responses to INO-4700 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial time points. A MERS pseudovirus neutralizing antibody responder was defined as a participant with a sample post-treatment 50% inhibitory dose (ID50) that was >20. Percentage responders were calculated based on number of responders at specified visit divided by number of participants evaluable at specified visit.
Measured: At Week 6
Part 1: Percentage Neutralizing Antibody Responders at Week 10
The immune responses to INO-4700 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial time points. A MERS pseudovirus neutralizing antibody responder was defined as a participant with a sample post-treatment 50% inhibitory dose (ID50) that was >20. Percentage responders were calculated based on number of responders at specified visit divided by number of participants evaluable at specified visit.
Measured: At Week 10
Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 6
Assessments of cellular immune responses to INO-4700 were performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs). A MERS spike ELISpot responder was defined as a participant with a post-treatment level that was > baseline + 2 standard deviations of replicate. Percentage responders were calculated as on number of responders at specified visit divided by number of participants evaluable at specified visit.
Measured: At Week 6
Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 10
Assessments of cellular immune responses to INO-4700 were performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs). A MERS spike ELISpot responder was defined as a participant with a post-treatment level that was > baseline + 2 standard deviations of replicate. Percentage responders were calculated as on number of responders at specified visit divided by number of participants evaluable at specified visit.
Measured: At Week 10
Part 2: Percentage of Participants With Adverse Events
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have causal relationship with treatment.
Measured: From the first dose of the study drug up to the end of the study (up to 68 weeks)
Part 2: Percentage of Participants With Injection Site Reactions
Reactions arising from the injectable product administration procedure were reported as injection site reactions. Injection site reactions were assessed in accordance with the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials' (FDA Guidance for Industry, September 2007). Local reactions to the injectable product such as pain, tenderness, erythema/redness, and induration/swelling were recorded. Injection site reactions were evaluated starting 30 minutes following the injection.
Measured: From the first dose of the study up to the end of the study (up to 68 weeks)
Part 2: Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Principal Investigator to the Sponsor can be appropriate. These included respiratory distress syndrome, pneumonia, neurologic, hematologic, immunologic, and other events (including local or systemic SAEs, acute renal failure, SARS-CoV-2 infection, or death). In addition, anxiety and pain related to the EP procedure were monitored.
Measured: From Screening up to the end of the study (up to 68 weeks)
Part 2: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody
Whole blood and serum samples were collected for the cellular immunology assessment. MERS receptor binding domain (RBD) immunoglobulin G (IgG) concentrations in response to administration of INO-4700 in combination were to be assessed.
Measured: At Week 12
Part 2: Percentage Neutralizing Antibody Responders
The immune responses to INO-4700 were to be measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were to be collected at serial timepoints.
Measured: At Week 12
Part 2: Percentage of Antigen Specific Cellular Immune Responders
Assessments of cellular immune responses to INO-4700 were to be performed using the immune response measured by interferon-gamma (IFN-γ) enzyme-linked immunospot (ELISpot) assay on peripheral blood mononuclear cells (PBMCs).
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start21 Jun 2021
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Middle East Respiratory Syndrome Coronavirus (MERS-CoV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inovio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Coalition for Epidemic Preparedness Innovations
- Responsible party
- Sponsor
- Investigators
- Bonaventure Orizu, MD, Study director, Inovio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588428
- Sponsor's protocol ID
- MERS-201
- Status last verified
- Jan 2026
- First submitted
- 6 Oct 2020
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Publications
Agnes JT, Marcus SA, Al-Ghraibeh SS, Al-Sweedan SA, Kosgei J, Ogutu B, Yang S, Walker KA, Orizu B, Broderick KE, Boyer J, Ramos S, Morrow MP, Kraynyak K, Sylvester AJ, Gillespie E, Liebowitz D, Humeau LM. Safety, tolerability, and immunogenicity of a DNA-based vaccine (INO-4700) against Middle East respiratory syndrome coronavirus: phase 2a study in healthy volunteers. Front Immunol. 2025 Nov 14;16:1662923. doi: 10.3389/fimmu.2025.1662923. eCollection 2025.
PubMed 41322416