NCT04588428Phase 2Completed

Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-01-19Actual

Enrollment · participants192Actual

Source updated2026-01-22Last update listed in the registry record

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Last 12 months

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Posted 2026-01-22 · 1 field changed

Main study measure wording changed

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− Before

Measure: ~~Frequency of Adverse Events in~~ Part 1 ~~Measure~~: Percentage of Participants ~~with~~ Adverse Events in Part 1 ~~Measure: Frequency of Injection Site Reactions in Part 1 Measure~~: Percentage of Participants ~~with~~ Injection Site Reactions in Part 1 ~~Measure~~: ~~Frequency~~ of Adverse Events of Special Interest (AESIs) in Part 1 Measure: Percentage of Participants ~~with~~ Adverse Events of Special Interest (AESIs) in Part ~~1 Measure~~: Geometric Mean ~~Titers~~ (~~GMTs~~) of ~~MERS~~-~~CoV~~ Antigen Specific Binding ~~Antibodies in Part 1~~ Measure: Percentage ~~MERS-CoV Antigen Specific~~ Neutralizing ~~Antibodies~~ ~~in Part 1~~ Measure: Percentage Antigen Specific Cellular Immune Response in Part 1 Measure: Percentage of Seroconverted Participants in Part 1 Measure: Percentage of Participants with Overall Immune Response in Part 1 Measure: Frequency of Adverse Events in Part 2 Measure: Percentage of Participants with Adverse Events in Part 2 Measure: Frequency of Injection Site Reactions in Part 2 Measure: Percentage of Participants with Injection Site Reactions in Part 2 Measure: Frequency of Adverse Events of Special Interest (AESIs) in Part 2 Measure: Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2 Measure: Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2 Measure: Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2 Measure: Percentage Antigen Specific Cellular Immune Response in Part 2 Measure: Percentage of Seroconverted Participants in Part 2 Measure: Percentage of Participants with Overall Immune Response in Part 2

+ After

Measure: Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs Measure: Part 1: Percentage of Participants With Injection Site Reactions Measure: Part 1: Percentage of Participants With Adverse Events of Special Interest (AESIs) Measure: Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 6 Measure: Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 6 Measure: Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 10 Measure: Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 10 Measure: Part 1: Percentage Neutralizing Antibody Responders at Week 6 Measure: Part 1: Percentage Neutralizing Antibody Responders at Week 10 Measure: Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 6 Measure: Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 10 Measure: Part 2: Percentage of Participants With Adverse Events Measure: Part 2: Percentage of Participants With Injection Site Reactions Measure: Part 2: Percentage of Participants With Adverse Events of Special Interest (AESIs) Measure: Part 2: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody Measure: Part 2: Percentage Neutralizing Antibody Responders Measure: Part 2: Percentage of Antigen Specific Cellular Immune Responders

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Study details

Conditions studied

Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Treatments or interventions studied

INO-4700Drug
PlaceboDrugAlso known as SSC-0001
INO-4700Drug

Primary outcomes · main study measures

Read the study measures

measure: Part 1: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Graded by Severity, and Treatment-related AEs; description: 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).; timeFrame: From the first dose of the study drug up to the end of the study (up to 48.7 weeks); measure: Part 1: Percentage of Participants With Injection Site Reactions; description: 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.; timeFrame: From the first dose of the study drug up to the end of the study (up to 48.7 weeks); measure: Part 1: Percentage of Participants With Adverse Events of Special Interest (AESIs); description: 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.; timeFrame: From Screening to the end of the study (up to 48.7 weeks); measure: Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 6; description: 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.; timeFrame: At Week 6; measure: Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 6; description: 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.; timeFrame: At Week 6; measure: Part 1: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody at Week 10; description: 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.; timeFrame: At Week 10; measure: Part 1: Geometric Mean Fold Rise (GMFR) of INO-4700 Antigen Specific Binding Antibody at Week 10; description: 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.; timeFrame: At Week 10; measure: Part 1: Percentage Neutralizing Antibody Responders at Week 6; description: 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.; timeFrame: At Week 6; measure: Part 1: Percentage Neutralizing Antibody Responders at Week 10; description: 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.; timeFrame: At Week 10; measure: Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 6; description: 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.; timeFrame: At Week 6; measure: Part 1: Percentage of Antigen Specific Cellular Immune Responders at Week 10; description: 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.; timeFrame: At Week 10; measure: Part 2: Percentage of Participants With Adverse Events; description: 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.; timeFrame: From the first dose of the study drug up to the end of the study (up to 68 weeks); measure: Part 2: Percentage of Participants With Injection Site Reactions; description: 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.; timeFrame: From the first dose of the study up to the end of the study (up to 68 weeks); measure: Part 2: Percentage of Participants With Adverse Events of Special Interest (AESIs); description: 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.; timeFrame: From Screening up to the end of the study (up to 68 weeks); measure: Part 2: Geometric Mean Concentration (GMC) of INO-4700 Antigen Specific Binding Antibody; description: 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.; timeFrame: At Week 12; measure: Part 2: Percentage Neutralizing Antibody Responders; description: 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.; timeFrame: At Week 12; measure: Part 2: Percentage of Antigen Specific Cellular Immune Responders; description: 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).; timeFrame: At Week 12

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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