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

NCT04627675 | Terminated Phase 1 Results FDA Drug FDA Device

• 1 other identifier: 2020000320 CORVax12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (16)

• 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.)

  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

Study Arms (4)

1A: Age 18-50; CORVax

EXPERIMENTAL

Healthy volunteers age 18-50 will receive CORVax

Drug: CORVax; Device: Cliniporator

1B: Age 18-50; CORVax + pIL-12

EXPERIMENTAL

Healthy volunteers age 18-50 will receive CORVax + pIL-12

Drug: CORVax; Drug: IL-12 plasmid; Device: Cliniporator

2A: Age > 50; CORVax

EXPERIMENTAL

Healthy volunteers age \> 50 will receive CORVax

Drug: CORVax; Device: Cliniporator

2B: Age > 50; CORVax + pIL-12

EXPERIMENTAL

Healthy volunteers age \> 50 will receive CORVax + pIL-12

Drug: CORVax; Drug: IL-12 plasmid; Device: Cliniporator

Interventions

CORVax DRUG

DNA-encodable coronaviral vaccine

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

IL-12 plasmid DRUG

cytokine

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

Cliniporator DEVICE

electroporation system

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• OncoSec Medical Incorporated: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Results Point of Contact

• Title: Dr. Rom Leidner
• Organization: Providence Portland Medical Center

rom.leidner@providence.org

503-215-5696

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 13, 2020
• Study Start: December 30, 2020
• Primary Completion: September 19, 2022
• Study Completion: December 28, 2022
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)