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| ID | Type | Description | Link |
|---|---|---|---|
| INNOVATE | Other Identifier | Inovio INO-4800 Vaccine Trial for Efficacy | |
| WHO UTN: U1111-1266-9952 | Other Identifier | World Health Organization (WHO) |
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The study was terminated to prioritize Inovio's COVID-19 efforts to advance a heterologous booster strategy and optimize potential impact on global public health.
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| Name | Class |
|---|---|
| Advaccine (Suzhou) Biopharmaceuticals Co., Ltd. | INDUSTRY |
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This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2).
The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 2: INO-4800 Dose Group 1 | Experimental | Participants received one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
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| Phase 2: INO-4800 Dose Group 2 | Experimental | Participants received two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
| Phase 2: Placebo Dose Group 1 | Placebo Comparator | Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
| Phase 2: Placebo Dose Group 2 | Placebo Comparator | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
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| Phase 3: INO-4800 Dose Group (2.0mg per dosing visit) | Experimental | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INO-4800 | Drug | INO-4800 was administered ID on Day 0 and Day 28. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay | Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed. | Baseline up to Week 6 |
| Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay | The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial timepoints. No samples collected after Week 6 were analyzed. | Baseline up to Week 6 |
| Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Virologically-confirmed COVID-19 Disease | Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with no prior exposure to COVID-19 at baseline were considered for the analysis. | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 2 and 3: Percentage of Participants With Solicited 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' (Food and Drug Administration [FDA] Guidance for Industry, September 2007). Participants were provided a diary to record the solicited injection site reactions. 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 solicited injection site reactions were recorded for 7 days after each dose. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Suaya | Inovio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synexus Clinical Research US, Inc - Phoenix Southeast | Chandler | Arizona | 85224 | United States | ||
| Central Phoenix Synexus Clinical Research |
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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In the Phase 2 segment, 618 participants were screened, of which 401 participants were enrolled to receive INO-4800 or placebo. In the Phase 3 segment, 978 participants were screened, of which 906 participants were enrolled to receive INO-4800 or placebo.
For the phase 2 segment, participants were enrolled at 16 study sites in the United States. For the Phase 3 segment, participants were enrolled at 11 study sites in Colombia and Mexico. They were enrolled between 30 November 2020 to 13 September 2022
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 2: INO-4800 Dose Group 1 | Participants received one intradermal (ID) injection of 1.0 milligram (mg) of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| FG001 | Phase 2: INO-4800 Dose Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Mar 8, 2022 | Oct 16, 2023 |
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| Phase 3: Placebo Dose Group | Placebo Comparator | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
| CELLECTRA® 2000 | Device | EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28. |
|
| Placebo | Drug | Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28. |
|
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| CELLECTRA® 2000 | Device | EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28. |
|
| 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35) |
| Phase 2 and 3: Percentage of Participants With Unsolicited 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 reported. Injection site reactions were evaluated starting 30 minutes following the injection. Unsolicited injection site reactions were recorded for up to 28 days after administration of dose 2. | From first dose of study drug up to Day 56 |
| Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were provided a diary to record the solicited systemic AEs. The solicited AEs were recorded for 7 days after each dose. | 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35) |
| Phase 2 and 3: Percentage of Participants With Unsolicited AEs | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs were recorded for up to 28 days after administration of dose 2. | From first dose of study drug up to Day 56 |
| Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly or birth defect. | Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126 |
| Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. | Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126 |
| Phase 3: Number of Participants With Death From All Causes | Baseline up to Day 126 |
| Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Non-Severe COVID-19 Disease | The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. The case definition for non-severe COVID-19 was participants with confirmed COVID-19, and which did not meet the case definition of severe COVID-19. | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
| Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Severe COVID-19 Disease | The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
| Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Death From COVID-19 Disease | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
| Phase 3: Percentage of Participants (SARS-CoV-2 Seropositive at Baseline) With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease | Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with prior exposure to COVID-19 at baseline were considered for the analysis. | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
| Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay | Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 were measured using ELISpot. | Baseline up to Day 126 |
| Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay | The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. | Baseline up to Day 126 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| AMR Tempe | Tempe | Arizona | 85283 | United States |
| Optimal Research, LLC | San Diego | California | 92108 | United States |
| AMR South Florida | Coral Gables | Florida | 33134 | United States |
| Clinical Research Trials of Florida, Inc | Tampa | Florida | 33607 | United States |
| AMR Lexington | Lexington | Kentucky | 40509 | United States |
| Walter Reed Army Institute of Research | Silver Spring | Maryland | 20910 | United States |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | United States |
| AMR Kansas City | Kansas City | Missouri | 64114 | United States |
| AMR, Clinical Research Consortium- Las Vegas | Las Vegas | Nevada | 89119 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Tekton Research | San Antonio | Texas | 78229 | United States |
| DM Clinical Research | Tomball | Texas | 78229 | United States |
| Advanced Clinical Research | West Jordan | Utah | 84088 | United States |
| Centro de Investigacion Medico Asistencial S.A.S | Barranquilla | Atlántico | 800001 | Colombia |
| Clinica de la Costa LTDA | Barranquilla | Atlántico | 80002 | Colombia |
| Corazon IPS S.A.S | Barranquilla | Atlántico | 80020 | Colombia |
| Ips Centro Cientifico Asistencial Sas | Barranquilla | Atlántico | 80020 | Colombia |
| Centro de Investigaciones Clinicas IPS Cardiomet Pereira | Pereira | Risaralda Department | 660003 | Colombia |
| BRCR Global Mexico | Guadalajara | Jalisco | 44600 | Mexico |
| Eukarya Pharmasite SC | Monterrey | Nuevo León | 64718 | Mexico |
| Unidad de Medicina Especializada SMA | San Juan del Río | Querétaro | 76800 | Mexico |
| Clinstile, SA de CV | Mexico City | 06700 | Mexico |
| SMIQ, S. de R. L. de C.V. | Querétaro | 76070 | Mexico |
| FAICIC S. de R.L. de C.V. | Veracruz | 91900 | Mexico |
Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| FG002 | Phase 2: Placebo Dose Group 1 | Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| FG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| FG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| FG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| Intention-to-treat (ITT) Population | ITT population included all participants who were randomized. |
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| Per Protocol (PP) Population | PP population included all participants who received all doses of the trial intervention and had no key protocol violations. |
|
| Safety Population | Safety population included all participants who received at least 1 dose of the trial intervention. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
ITT population included all participants who were randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2: INO-4800 Dose Group 1 | Participants received one ID injection of 1.0 mg of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| BG001 | Phase 2: INO-4800 Dose Group 2 | Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| BG002 | Phase 2: Placebo Dose Group 1 | Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| BG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| BG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| BG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay | Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 was measured in spot-forming units per million peripheral blood mononuclear cells (SFU/10^6, PBMC) using ELISpot. No samples collected after Week 6 were analyzed. | PP population included all participants who received all doses of the trial intervention and had no key protocol violations. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' denotes the number of participants available at individual timepoints. | Posted | Median | Full Range | SFU/10^6, PBMC | Baseline up to Week 6 |
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| Primary | Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay | The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. Immunology blood samples were collected at serial timepoints. No samples collected after Week 6 were analyzed. | PP population included all participants who received all doses of the trial intervention and had no key protocol violations. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' denotes the number of participants available at individual timepoints. | Posted | Geometric Mean | Standard Deviation | inhibition dilution 50 (ID50) | Baseline up to Week 6 |
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| Primary | Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Virologically-confirmed COVID-19 Disease | Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with no prior exposure to COVID-19 at baseline were considered for the analysis. | For the Phase 3 segment, as pre-specified in the protocol, an independent endpoint adjudication committee (EAC) was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure. | Posted | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
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| Secondary | Phase 2 and 3: Percentage of Participants With Solicited 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' (Food and Drug Administration [FDA] Guidance for Industry, September 2007). Participants were provided a diary to record the solicited injection site reactions. 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 solicited injection site reactions were recorded for 7 days after each dose. | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Number | percentage of participants | 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35) |
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| Secondary | Phase 2 and 3: Percentage of Participants With Unsolicited 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 reported. Injection site reactions were evaluated starting 30 minutes following the injection. Unsolicited injection site reactions were recorded for up to 28 days after administration of dose 2. | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Number | percentage of participants | From first dose of study drug up to Day 56 |
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| Secondary | Phase 2 and 3: Percentage of Participants With Solicited Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Participants were provided a diary to record the solicited systemic AEs. The solicited AEs were recorded for 7 days after each dose. | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Number | percentage of participants | 7 days following each dose: Day 0 (Days 0 to Day 7) and Day 28 (Days 28 to Day 35) |
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| Secondary | Phase 2 and 3: Percentage of Participants With Unsolicited AEs | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AEs were recorded for up to 28 days after administration of dose 2. | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Number | percentage of participants | From first dose of study drug up to Day 56 |
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| Secondary | Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs) | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or results in congenital anomaly or birth defect. | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Number | percentage of participants | Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126 |
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| Secondary | Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a participant administered a trial intervention that does not necessarily have a causal relationship with this treatment. An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate. | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Number | percentage of participants | Phase 2: From first dose of study drug up to Day 393; Phase 3: From first dose of study drug up to Day 126 |
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| Secondary | Phase 3: Number of Participants With Death From All Causes | Safety population included all participants who received at least one dose of the trial intervention. | Posted | Count of Participants | Participants | Baseline up to Day 126 |
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| Secondary | Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Non-Severe COVID-19 Disease | The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. The case definition for non-severe COVID-19 was participants with confirmed COVID-19, and which did not meet the case definition of severe COVID-19. | For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure. | Posted | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
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| Secondary | Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Severe COVID-19 Disease | The efficacy of INO-4800 in the prevention of COVID-19 disease was evaluated according to the degrees of COVID-19 disease severity in participants. Participants were confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. The case definition of severe COVID-19 was participants with COVID-19 having clinical signs at rest indicative of severe systemic illness, respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to an intensive care unit, or death. | For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure. | Posted | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
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| Secondary | Phase 3: Percentage of Participants (SARS-CoV-2 Seronegative at Baseline) With Death From COVID-19 Disease | For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure. | Posted | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
|
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| Secondary | Phase 3: Percentage of Participants (SARS-CoV-2 Seropositive at Baseline) With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease | Participants were virologically-confirmed cases of COVID-19, if tested positive by SARS-CoV-2 RT-PCR assay, with symptoms like fever (temperature of 100.4ºF/38.0ºC or higher), chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea, vomiting, diarrhoea. Participants with prior exposure to COVID-19 at baseline were considered for the analysis. | For the Phase 3 segment, as pre-specified in the protocol, an independent EAC was to review and confirm the suspected COVID-19 cases which fulfilled the definition for virologically-confirmed COVID-19 cases. As the trial was prematurely terminated, suspected COVID-19 cases were not reconciled with the EAC. Therefore, data that was planned for the EAC to reconcile was not available for efficacy analysis and data could not be reported for the outcome measure. | Posted | From 14 days after completion of the 2-dose regimen up to 3 months post-dose 2 (i.e. Day 42 up to Day 126) |
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| Secondary | Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay | Whole blood and serum samples were collected for the cellular immunology assessment. The antigen-specific cellular immune response to INO-4800 were measured using ELISpot. | Due to the early termination of the study, immunogenicity analysis that was pre-specified in the protocol was not performed in the Phase 3 segment of the study. Hence, data for this outcome measure was not collected. | Posted | Baseline up to Day 126 |
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| Secondary | Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay | The immune responses to INO-4800 were measured using assays that included a pseudovirus-based neutralization assay. | Due to the early termination of the study, immunogenicity analysis that was pre-specified in the protocol was not performed in the Phase 3 segment of the study. Hence, data for this outcome measure was not collected. | Posted | Baseline up to Day 126 |
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Phase 2: From the first dose of the study drug up to Day 393; Phase 3: From the first dose of the study drug up to Day 126
Safety population included all participants who received at least one dose of the trial intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 2: INO-4800 Dose Group 1 | Participants received one ID injection of 1.0 mg of INO-4800 followed by electroporation (EP) using the CELLECTRA® 2000 device on Day 0 and Day 28. | 0 | 151 | 4 | 151 | 115 | 151 |
| EG001 | Phase 2: INO-4800 Dose Group 2 | Participants received 2 ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. | 0 | 147 | 2 | 147 | 127 | 147 |
| EG002 | Phase 2: Placebo Dose Group 1 | Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. | 1 | 50 | 3 | 50 | 42 | 50 |
| EG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. | 0 | 51 | 2 | 51 | 38 | 51 |
| EG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. | 2 | 601 | 4 | 601 | 279 | 601 |
| EG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. | 2 | 302 | 4 | 302 | 140 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.0 | Systematic Assessment |
| |
| Major depression | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Inovio Pharmaceuticals | 267-440-4237 | clinical.trials@inovio.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2022 | Oct 16, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706171 | reluscovtogene ralaplasmid |
Not provided
Not provided
Not provided
| 51-64 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Change From Baseline at Week 6 |
|
|
| Difference in median |
| 13.30 |
| Standard Error of the Mean |
| 10.55 |
| 2-Sided |
| 95 |
| 3.30 |
| 17.80 |
Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI. |
| Other |
| Difference in median | -6.60 | Standard Error of the Mean | -5.00 | 2-Sided | 95 | -10.00 | 0.00 | Post-baseline change from baseline in IFN-gamma ELISpot response magnitudes was compared between groups using differences in medians and associated non-parametric 95% CI. | Other |
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
|
|
| OG002 | Phase 2: Placebo Dose Group 1 | Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
| Phase 2: Placebo Dose Group 1 |
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
| OG003 | Phase 2: Placebo Dose Group 2 | Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG004 | Phase 3: INO-4800 Dose Group (2.0mg Per Dosing Visit) | Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
| OG005 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
|
| OG001 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
| OG001 | Phase 3: Placebo Dose Group | Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28. |
|
|
|