Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults

• Status: Recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized (4:1) Phase 1 b safety trial in adults who have completed their full COVID-19 vaccination schedule at least 30 days prior to study entry.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oncovir, Inc.
• Collaborator: University of Calgary
• Treatments: Carboxymethylcellulose Sodium; Poly I-C; Poly ICLC

Criteria

Inclusion Criteria for Enrollment

1. Phase I Cohort A: Subjects must be between 18 and 69 years of age. Phase 1b Cohort B:

Subjects must be 18 years of age or older. In order to mitigate risk, no participants over age 70 will be recruited in Cohort A.

2. Asymptomatic; defined by experiencing none of the symptoms identified in the Symptom Questionnaire

1. fever

2. cough

3. dyspnea

4. fatigue

5. muscle or joint pain

6. sore throat

7. stuffy or runny nose

8. nausea/vomiting

9. headache

10. confusion

11. diarrhea

12. loss of smell or taste

3. Nasopharyngeal swab for COVID-19 at screening with negative diagnosis of SARS-CoV-2

4. Willing and able to provide blood, nasopharyngeal swab, and nasal mononuclear samples

5. Healthy individuals fully vaccinated with an mRNA COVID-19 vaccine (Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine (mRNA-173) and who have had their last dose of COVID-19 vaccination at least 30 days prior to study entry. The vaccination dates of the doses, and specific vaccine received will be recorded. Accrual will be limited to participants who have received one of the two available mRNA vaccines to reduce potential variability in the study and to minimize any yet unknown variables in the immunologic data.

6. Able to provide informed consent

7. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use adequate methods of contraception (described below) during the study treatment and through 90 days after the last dose of study medication. Female participants of childbearing potential are all those except participants who are surgically sterile, who have medically documented ovarian failure, or who are at least 1 year postmenopausal

8. Acceptable Hematologic, renal and liver functions as follows:

1. Absolute neutrophil count > 1000/mcL 2. Platelets > 50,000/mcL 3. Hemoglobin >9 g/dL 4. Serum Creatinine ≤ 2.5 mg/dl 5. Liver Function:

• Total bilirubin ≤1.5 mg/dl

• AST ≤ 2.0 mg/dl (≤120 IU or 3x ULN)

Exclusion Criteria

1. Individuals not yet fully vaccinated with a COVID-19 vaccine or fully vaccinated with a COVID-19 vaccine other than an mRNA COVID-19 vaccine.

2. Receipt of any blood product in past 120 days

3. Allergic rhinitis, chronic sinusitis, or other nasal inflammatory disease that requires daily intranasal or oral medication

4. Chronic medical problems that require daily nasal administration of medication

5. Prior nasal or sinus surgery including trans nasal approaches to brain

6. Chronic pulmonary conditions including severe asthma, COPD, or chronic bronchitis

7. Autoimmune hepatitis, decompensated liver disease, cardiac ischemia, congestive heart failure, cardiac arrhythmia, neutropenia, thrombocytopenia, severe renal insufficiency

8. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect participant safety and/or compliance

9. Symptoms consistent with COVID-19 infection (fevers, acute onset cough, shortness of breath) at time of screening

10. Nucleic acid testing evidence of COVID-19 infection at time of screening

11. Participants must not be pregnant or nursing due to the unknown potential for congenital abnormalities and the potential of this regimen to harm nursing infants.

12. Has a diagnosis of primary immunodeficiency

13. Has uncontrolled hypertension that in the opinion of the principal investigator poses unacceptable risk.

14. Has active autoimmune disease that has required systemic treatment in the past 1 year

1. (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)

2. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable

15. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator

16. Principle investigator believes that for one or multiple reasons the participant will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the participant

17. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)

18. Active, untreated tuberculosis