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Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.
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| Name | Class |
|---|---|
| OncoSec Medical Incorporated | INDUSTRY |
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This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid.
This is a Phase 1, open-label study to evaluate the safety profile of CORVax +/- pIL-12, (electroporated SARS-CoV-2 spike (S) protein plasmid DNA vaccine with or without the combination of electroporated IL-12p70 plasmid), given as prime & boost doses, four weeks apart, in healthy volunteers, divided into age groups of 18-50 versus > 50 years old. IL-12p70 plasmid DNA electroporation (tavokinogene telseplasmid) has been extensively studied in over 209 subjects across 11 trials including later stage human cancer trials with more than 1000 administrations. The IGEA CLINIPORATOR® system is approved for clinical use in Europe, but remains investigational in this study.
One participant will initially be enrolled to each of four cohorts and monitored over a 7-day DLT window:
1A. Age 18-50; CORVax.
2B. Age > 50; CORVax + pIL-12.
If after 7 days, no DLT are observed, the cohort may proceed to enroll a second participant. If after monitoring the second participant for 7 days, no DLT are observed, the cohort may proceed to enroll a third participant. If after monitoring the third participant for 7 days, no DLT are observed, the cohort may proceed to enroll six additional participants, for a total of nine participants per cohort using a (1+1+1, +6) design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1A: Age 18-50; CORVax | Experimental | Healthy volunteers age 18-50 will receive CORVax |
|
| 1B: Age 18-50; CORVax + pIL-12 | Experimental | Healthy volunteers age 18-50 will receive CORVax + pIL-12 |
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| 2A: Age > 50; CORVax | Experimental | Healthy volunteers age > 50 will receive CORVax |
|
| 2B: Age > 50; CORVax + pIL-12 | Experimental | Healthy volunteers age > 50 will receive CORVax + pIL-12 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORVax | Drug | DNA-encodable coronaviral vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events Occurring on Day 1 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 1 |
| Number of Participants With Adverse Events Occurring on Day 2 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 2 |
| Number of Participants With Adverse Events Occurring on Day 3 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 3 |
| Number of Participants With Adverse Events Occurring on Day 15 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 15 |
| Number of Participants With Adverse Events Occurring on Day 30 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 30 |
| Number of Participants With Adverse Events Occurring on Day 31 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Providence Portland Medical Center | Portland | Oregon | 97213 | United States |
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Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1A: Age 18-50; CORVax | Healthy volunteers age 18-50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system |
| FG001 | 1B: Age 18-50; CORVax + pIL-12 | Healthy volunteers age 18-50 will receive CORVax + pIL-12 CORVax: DNA-encodable coronaviral vaccine IL-12 plasmid: cytokine Cliniporator: electroporation system |
| FG002 | 2A: Age > 50; CORVax | Healthy volunteers age > 50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system |
| FG003 | 2B: Age > 50; CORVax + pIL-12 | Healthy volunteers age > 50 will receive CORVax + pIL-12 CORVax: DNA-encodable coronaviral vaccine IL-12 plasmid: cytokine Cliniporator: electroporation system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
16 patients were enrolled into the study, however 1 withdrew prior to treatment and 4 were found ineligible during the screening visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1A: Age 18-50; CORVax | Healthy volunteers age 18-50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system |
| BG001 | 1B: Age 18-50; CORVax + pIL-12 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants With Adverse Events Occurring on Day 1 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 1 |
|
For adverse events, up to Day 90. For medically attended adverse events, starting at Day 30 to Month 18.
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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 | 1A: Age 18-50; CORVax | Healthy volunteers age 18-50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased CPK | Investigations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rom Leidner | Providence Portland Medical Center | 503-215-5696 | rom.leidner@providence.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2021 | Jul 6, 2023 | Prot_SAP_000.pdf |
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| IL-12 plasmid | Drug | cytokine |
|
| Cliniporator | Device | electroporation system |
|
| Day 31 |
| Number of Participants With Adverse Events Occurring on Day 32 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 32 |
| Number of Participants With Adverse Events Occurring on Day 45 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 45 |
| Number of Participants With Adverse Events Occurring on Day 60 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 60 |
| Number of Participants With Adverse Events Occurring on Day 90 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Day 90 |
| Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs). | Day 30 |
| Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Day 60 |
| Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Day 90 |
| Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Month 6 |
| Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Month 12 |
| Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Month 18 |
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
| BG002 | 2A: Age > 50; CORVax | Healthy volunteers age > 50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system |
| BG003 | 2B: Age > 50; CORVax + pIL-12 | Healthy volunteers age > 50 will receive CORVax + pIL-12 CORVax: DNA-encodable coronaviral vaccine IL-12 plasmid: cytokine Cliniporator: electroporation system |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Healthy volunteers age 18-50 will receive CORVax + pIL-12
CORVax: DNA-encodable coronaviral vaccine
IL-12 plasmid: cytokine
Cliniporator: electroporation system
| OG002 | 2A: Age > 50; CORVax | Healthy volunteers age > 50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system |
| OG003 | 2B: Age > 50; CORVax + pIL-12 | Healthy volunteers age > 50 will receive CORVax + pIL-12 CORVax: DNA-encodable coronaviral vaccine IL-12 plasmid: cytokine Cliniporator: electroporation system |
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 2 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 2 |
|
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 3 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 3 |
|
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 15 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 15 |
|
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 30 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 31 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 31 |
|
|
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| Primary | Number of Participants With Adverse Events Occurring on Day 32 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 32 |
|
|
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| Primary | Number of Participants With Adverse Events Occurring on Day 45 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 45 |
|
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 60 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 60 |
|
|
|
| Primary | Number of Participants With Adverse Events Occurring on Day 90 | Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (Grade 1 mild is the minimum value and Grade 4 life threatening is the maximum value.) | Study was terminated prematurely due to lack of efficacy. Per FDA guidance, enrolled patients were followed until Day 180 for safety. | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Primary | Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs). | Posted | Count of Participants | Participants | Day 30 |
|
|
|
| Primary | Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Posted | Count of Participants | Participants | Day 60 |
|
|
|
| Primary | Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Posted | Count of Participants | Participants | Day 90 |
|
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| Primary | Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Posted | Count of Participants | Participants | Month 6 |
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| Primary | Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Posted | Count of Participants | Participants | Month 12 |
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| Primary | Medically Attended Adverse Events (MAAEs) | Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs) | Posted | Count of Participants | Participants | Month 18 |
|
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| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 1B: Age 18-50; CORVax + pIL-12 | Healthy volunteers age 18-50 will receive CORVax + pIL-12 CORVax: DNA-encodable coronaviral vaccine IL-12 plasmid: cytokine Cliniporator: electroporation system | 0 | 3 | 1 | 3 | 3 | 3 |
| EG002 | 2A: Age > 50; CORVax | Healthy volunteers age > 50 will receive CORVax CORVax: DNA-encodable coronaviral vaccine Cliniporator: electroporation system | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | 2B: Age > 50; CORVax + pIL-12 | Healthy volunteers age > 50 will receive CORVax + pIL-12 CORVax: DNA-encodable coronaviral vaccine IL-12 plasmid: cytokine Cliniporator: electroporation system | 0 | 3 | 0 | 3 | 3 | 3 |
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Decreased hemoglobin | Investigations | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Elevated creatinine | Investigations | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Increased BUN | Investigations | Systematic Assessment |
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| Increased CPK | Investigations | Systematic Assessment |
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| Injection site redness | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Pain at electroporation site | General disorders | Systematic Assessment |
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| Pain at injection site | General disorders | Systematic Assessment |
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| Pruritus at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Reduced appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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