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CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (CORVax12)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04627675
Recruitment Status : Active, not recruiting
First Posted : November 13, 2020
Last Update Posted : June 3, 2021
Sponsor:
Collaborator:
OncoSec Medical Incorporated
Information provided by (Responsible Party):
Providence Health & Services

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE November 13, 2020
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE December 30, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2020)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: Days 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Toxicity [ Time Frame: 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.)
  • Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 30 ]
    Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs).
  • Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 60 ]
    Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
  • Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 90 ]
    Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
  • Medically Attended Adverse Events (MAAEs) [ Time Frame: Month 6 ]
    Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
  • Medically Attended Adverse Events (MAAEs) [ Time Frame: Month 12 ]
    Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
  • Medically Attended Adverse Events (MAAEs) [ Time Frame: Month 18 ]
    Extended monitoring of Medically Attended Adverse Events (MAAEs) for potentially immune-mediated conditions (pIMMCs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2)
Official Title  ICMJE CORVax12 - a Phase I Trial of SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine (CORVax) +/- pIL-12 (Tavokinogene Telseplasmid) in Healthy Volunteers, With Immunodynamic Biomarker Monitoring of Coordinated Cellular/Humoral Response
Brief Summary 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.
Detailed Description

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.

  1. B. Age 18-50; CORVax + pIL-12.
  2. A. Age > 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE SARS-CoV-2
Intervention  ICMJE
  • Drug: CORVax
    DNA-encodable coronaviral vaccine
  • Drug: IL-12 plasmid
    cytokine
  • Device: Cliniporator
    electroporation system
Study Arms  ICMJE
  • Experimental: 1A: Age 18-50; CORVax
    Healthy volunteers age 18-50 will receive CORVax
    Interventions:
    • Drug: CORVax
    • Device: Cliniporator
  • Experimental: 1B: Age 18-50; CORVax + pIL-12
    Healthy volunteers age 18-50 will receive CORVax + pIL-12
    Interventions:
    • Drug: CORVax
    • Drug: IL-12 plasmid
    • Device: Cliniporator
  • Experimental: 2A: Age > 50; CORVax
    Healthy volunteers age > 50 will receive CORVax
    Interventions:
    • Drug: CORVax
    • Device: Cliniporator
  • Experimental: 2B: Age > 50; CORVax + pIL-12
    Healthy volunteers age > 50 will receive CORVax + pIL-12
    Interventions:
    • Drug: CORVax
    • Drug: IL-12 plasmid
    • Device: Cliniporator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 12, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult volunteers ages 18 years and above, who are able to provide written informed consent and willing to allow storage and future use of samples for SARS-CoV-2 related research.
  • Women of childbearing potential (WOCBP) must have negative serum or urine pregnancy on each day of vaccine administration.
  • Males and women of childbearing potential must agree to take appropriate precautions to avoid pregnancy during treatment and through 180 days after last dose of IP.

Exclusion Criteria:

  • Current or previous SARS-CoV-2 infection or receipt of an experimental treatment for prevention of SARS-CoV-2.
  • Administration of any vaccine within 4 weeks of first dose.
  • Any laboratory abnormalities at baseline greater than Grade 1 per the "FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials": https://www.fda.gov/regulatory-information/search-fda-guidance-documents/toxicity-grading-scale-healthy-adult-and-adolescent-volunteers-enrolled-preventive-vaccine-clinical
  • Any history of cardiac arrhythmia.
  • Any history of epilepsy or seizure within the last five years.
  • Use of immunosuppressive medication within 14 days before the first dose of study drug.
  • Anticipated treatment with TNF-α inhibitors (e.g., infliximab, adalimumab, or etanercept).
  • Pregnancy or breastfeeding.
  • Body mass index of 35 kg/m2 or more.
  • Administration of any monoclonal or polyclonal antibody product within 4 weeks of the first dose.
  • Chronic liver disease or cirrhosis.
  • Previous major surgery or any radiation therapy within 4 weeks of group assignment.
  • Any pre-excitation syndromes (e.g., Wolff- Parkinson-White syndrome).
  • Metal implants within 20cm of the planned site(s) of injection; presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition at the planned site(s) of injection; tattoos covering the injection site area.
  • Presence of a cardiac pacemaker or automatic implantable cardioverter defibrillator.
  • History of allogeneic organ transplantation.
  • History of primary immunodeficiency.
  • Known HIV, hepatitis B virus, or hepatitis C virus infection. Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible.
  • Uncontrolled intercurrent illness, including but not limited to symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, unstable cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent.
  • Comorbidities, controlled or otherwise, associated with higher risk for severe COVID-19 illness - because our understanding of the pathogenesis of SARS-CoV-2 continues to evolve, this will be based on most current information available at time of screening regarding risk factors for severe disease, using resources such as those described on the Centers for Disease Control website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-at-higher-risk.html
  • Subjects at high-risk for SARS-CoV-2 exposure per investigator, including healthcare workers, first responders, and individuals with known exposure to individuals infected with SARS-CoV-2.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice).
  • History of autoimmune or inflammatory disorders including but not limited to inflammatory bowel disease (e.g., colitis or Crohn's disease), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, (see Appendix 2).
  • Known allergy or hypersensitivity to study drug(s) or compounds of similar biologic composition to the study drug(s), or any of the study drug excipients.
  • Investigator discretion relating to any condition which might interfere with study requirements.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04627675
Other Study ID Numbers  ICMJE 2020000320 CORVax12
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Providence Health & Services
Study Sponsor  ICMJE Providence Health & Services
Collaborators  ICMJE OncoSec Medical Incorporated
Investigators  ICMJE Not Provided
PRS Account Providence Health & Services
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP