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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
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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 CELLECTRAâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
|
| Part 1: INO-4700 Group B | Experimental | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
|
| Part 1: INO-4700 Group C | Experimental | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
|
| 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
|
| 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INO-4700 | Drug | INO-4700 was administered ID. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventure Orizu, MD | Inovio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, Irbid Specialty Hospital (CRC/ISH) | Irbid | 21110 | Jordan | |||
| Pharmaceutical Research Center / Jordan University of Science and Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41322416 | Derived | 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. |
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Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.
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This study was planned for two parts i.e., Part 1 and Part 2. A total of 218 participants were screened for Part 1 of the study, out of which 192 participants were enrolled. Part 1 was to select the optimal dose for Part 2. However, none of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1. The data is reported only for Part 1.
Healthy adult volunteers were enrolled at 6 study sites between 21 June 2021 and 19 January 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: INO-4700 Group A | Participants received one intradermal (ID) injection of 0.6 milligram (mg) of INO-4700 followed by electroporation (EP) using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| FG001 | Part 1: INO-4700 Group B | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| FG002 | Part 1: INO-4700 Group C | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| FG003 | Part 1: INO-4700 Group D | 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| FG004 | Part 1: INO-4700 Group E | 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| FG005 | Part 1: Placebo Group F | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| FG006 | Part 1: Placebo Group G | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| FG007 | Part 1: Placebo Group H | Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| FG008 | Part 1: Placebo Group I | Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The modified intent to treat (mITT) population included all participants who received at least one dose of the INO-4700 or placebo.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: INO-4700 Group A | Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| BG001 | Part 1: INO-4700 Group B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. Percentages are rounded off to the nearest decimal point. | Posted | Number | percentage of participants | From the first dose of the study drug up to the end of the study (up to 48.7 weeks) |
From the first dose of the study drug up to the end of the study (up to approximately 48.7 weeks)
The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. Hence, safety data has been reported for Part 1 only.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: INO-4700 Group A | Participants received one ID injection of 0.6 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Inovio Pharmaceuticals | 267-440-4237 | clinical.trials@inovio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2021 | Jan 5, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2021 | Jan 5, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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|
| Part 1: Placebo Group F | Placebo Comparator | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
|
| Part 1: Placebo Group G | Placebo Comparator | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
|
| 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
|
| 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
|
| 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 CELLECTRAâ„¢ 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). |
|
| Placebo | Drug | Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID. |
|
|
| CELLECTRAâ„¢ 2000 | Device | EP using the CELLECTRAâ„¢ 2000 device was administered following ID drug administration |
|
| INO-4700 | Drug | INO-4700 |
|
| CELLECTRAâ„¢ 2000 | Device | CELLECTRAâ„¢ 2000 |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | At Week 12 |
| Irbid |
| 22110 |
| Jordan |
| Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP) | Kericho | 20200 | Kenya |
| Ahero Clincal Trials Unit | Kisumu | 40100 | Kenya |
| American University of Beirut Medical Center | Beirut | Lebanon |
| Hammoud Hospital University Medical Center | Saida | Lebanon |
| Protocol Deviation |
|
| Reason Not Specified |
|
Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4.
| BG002 | Part 1: INO-4700 Group C | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| BG003 | Part 1: INO-4700 Group D | 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| BG004 | Part 1: INO-4700 Group E | 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| BG005 | Part 1: Placebo Group F | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| BG006 | Part 1: Placebo Group G | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| BG007 | Part 1: Placebo Group H | Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. |
| BG008 | Part 1: Placebo Group I | Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. |
| BG009 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. Percentages are rounded off to the nearest decimal point. | Posted | Number | percentage of participants | From the first dose of the study drug up to the end of the study (up to 48.7 weeks) |
|
|
|
| Primary | 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. | The safety population included all participants who received at least one dose of INO-4700 or placebo administered by ID injection. Percentage of participants are rounded off to the nearest decimal point. | Posted | Number | percentage of participants | From Screening to the end of the study (up to 48.7 weeks) |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | International Units per mL (IU/mL) | At Week 6 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | At Week 6 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | International Units per mL (IU/mL) | At Week 10 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | At Week 10 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Number | percentage of responders | At Week 6 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Number | percentage of responders | At Week 10 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Number | percentage of responders | At Week 6 |
|
|
|
| Primary | 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. | The mITT population included all participants who received at least one dose of the INO-4700 or placebo. 'Overall number of participants analyzed" indicates the number of participants with data available for this outcome measure. | Posted | Number | percentage of responders | At Week 10 |
|
|
|
| Primary | 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. | None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. | Posted | From the first dose of the study drug up to the end of the study (up to 68 weeks) |
|
|
| Primary | 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. | None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. | Posted | From the first dose of the study up to the end of the study (up to 68 weeks) |
|
|
| Primary | 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. | None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. | Posted | From Screening up to the end of the study (up to 68 weeks) |
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| Primary | 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. | None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. | Posted | At Week 12 |
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| Primary | 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. | None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. | Posted | At Week 12 |
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| Primary | 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). | None of the dose groups studied in Part 1 met the immunological criteria for advancement to Part 2. Consequently, the study ended at the conclusion of Part 1 and Part 2 was not conducted. | Posted | At Week 12 |
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| 0 |
| 32 |
| 0 |
| 32 |
| 6 |
| 32 |
| EG001 | Part 1: INO-4700 Group B | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. | 0 | 33 | 1 | 33 | 10 | 33 |
| EG002 | Part 1: INO-4700 Group C | Participants received one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. | 0 | 32 | 0 | 32 | 11 | 32 |
| EG003 | Part 1: INO-4700 Group D | 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. | 0 | 32 | 1 | 32 | 8 | 32 |
| EG004 | Part 1: INO-4700 Group E | 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 CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. | 0 | 31 | 0 | 31 | 11 | 31 |
| EG005 | Part 1: Placebo Group F | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG006 | Part 1: Placebo Group G | Participants received one ID injection of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. | 0 | 8 | 0 | 8 | 6 | 8 |
| EG007 | Part 1: Placebo Group H | Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 8. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG008 | Part 1: Placebo Group I | Participants received two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRAâ„¢ 2000 device on Day 0 and Week 4. | 0 | 8 | 0 | 8 | 4 | 8 |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
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| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 25.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Asymptomatic bacteriuria | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Urethritis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Blood glucose increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Blood bicarbonate decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Red blood cells urine | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | MedDRA 25.0 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
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Not provided
Not provided
| D007239 |
| Infections |
| Percentage of Participants With Injection Site Pruritis |
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