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.
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.
Drug: CORVax
DNA-encodable coronaviral vaccine
Drug: IL-12 plasmid
cytokine
Device: Cliniporator
electroporation system
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-document…
ing-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…
.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.
Providence Portland Medical Center
Portland, Oregon, United States