Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04672291|
Recruitment Status : Not yet recruiting
First Posted : December 17, 2020
Last Update Posted : June 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID - 19||Drug: Poly-ICLC (Hiltonol®) or Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Intranasal Poly-ICLC (Hiltonol®) or Placebo|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This study consists of 2 treatment groups. Study subjects will be assigned by chance to a treatment group. Group 1 receives the study drug; group 2 receives the placebo. Neither the study subject or the study team will know the group assignments. There will be a 4 out 5 chance of receiving the study drug and 1 out 5 chance of receiving the placebo.|
|Official Title:||A Phase I-Ib, Double-blinded, Randomized Repeated Dose Single Center, Safety and Immunogenicity Study of Nasal Poly-ICLC (Hiltonol®) in Healthy COVID-19 Vaccinated Adults|
|Estimated Study Start Date :||June 15, 2021|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||January 16, 2024|
Experimental: Safety Cohort
A randomized (4:1) initial safety cohort of 13 patients will receive 2 cycles of drug (N=10) or placebo (N=3)
Drug: Poly-ICLC (Hiltonol®) or Placebo
The safety cohort (Cohort A) consists of 13 patients who will be randomized to receive 2 cycles of the study drug (N10) or 2 placebo cycles (N3).
Other Name: Safety
Experimental: Expansion Cohort
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.
Drug: Poly-ICLC (Hiltonol®) or Placebo
The expansion cohort will receive 3 cycles of therapy. A total of 30 patients will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6).
Other Name: Expansion
- Safety and tolerability of nasally administered Poly-ICLC (Hiltonol®) in healthy adults. [ Time Frame: 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.
- Assess the response of the body to the study drug (pharmacodynamics) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04672291
|Contact: Andres M Salazar, MD||207 505 firstname.lastname@example.org|
|Contact: Richard Leigh, MBChB, PhDemail@example.com|
|Health Research Innovation Centre|
|Calgary, Alberta, Canada, T2N 4Z6|
|Contact: Curtis Dumonceaux, BSc, CCRP 403-220-2123 firstname.lastname@example.org|
|Contact: Linda Knox, RN, CRE 403-220-2123 email@example.com|
|Principal Investigator: Richard Leigh, MBChB, PhD|
|Study Director:||Andres M Salazar, MD||Sponsor GmbH|