Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults
- Registration Number
- NCT04672291
- Lead Sponsor
- Oncovir, Inc.
- Brief 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.
- Detailed Description
An initial cohort of 13 participants will receive 2 cycles of drug or placebo per the schedule below under carefully monitored conditions, including examinations to observe and document administration site reaction following consecutive administration cycles of the drug. 10 participants will receive drug and 3 will receive placebo. The safety stopping rule is to implement an enrollment pause if 2 dose limiting toxicity (DLT, see section 5.1) out of the first six or 3 DLTs out of the first 10 participants receiving drug are observed in either cycle 1 or cycle 2. The independent DSMB will conduct a review of the safety data to determine the relatedness of the DLTs to the drug exposure and provide a recommendation to continue. Thus, if safety events are determined to be not (or unlikely) related to drug exposure the trial may resume. The independent DSMB will review safety and tolerance data before the study can continue.
If at most 2 DLTs out of the 10 participants receiving drug are observed, then a Phase Ib expansion cohort will open. The expansion cohort will receive 3 cycles of therapy. A total of 30 participants will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6). There will be extensive assessment of toxicity and an early stopping rule to implement an enrollment pause and independent DSMB review of safety data to determine relatedness to drug exposure for recommendation of trial continuation, will be employed as above. Safety and tolerability will be the primary endpoint but secondary endpoints include changes in immunological parameters.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Safety Cohort Poly-ICLC (Hiltonol®) or Placebo A randomized (4:1) initial safety cohort of 13 patients will receive 2 cycles of drug (N=10) or placebo (N=3) Expansion Cohort Poly-ICLC (Hiltonol®) or Placebo A randomized (4:1) expansion cohort will receive 3 cycles of drug (N=24) or placebo (N=6). A total of 30 patients will be accrued.
- Primary Outcome Measures
Name Time Method Safety and tolerability of nasally administered Poly-ICLC (Hiltonol®) in healthy adults. 91 days Safety will be measured and tabulated by the number (percent) of participants who experience DLTs (grade 3/4 adverse events) from the start of therapy through the end of the follow up period (day 91), according to DAIDS.
- Secondary Outcome Measures
Name Time Method Assess the response of the body to the study drug (pharmacodynamics) 91 days Characterize the pharmacodynamics of the local and systemic innate immune response to repeated doses of intranasal Poly-ICLC (Hiltonol®) by investigating the effects on nasal mononuclear cells and systemic inflammatory markers
Trial Locations
- Locations (1)
Health Research Innovation Centre
🇨🇦Calgary, Alberta, Canada