NCT00646152

Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study

Completed Phase 1 Last updated 5 July 2018

What this trial tests

Phase 1 trial testing Poly-ICLC in Influenza in 57 participants. Completed in 16 December 2009.

Timeline

24 March 2008

Primary endpoint
16 December 2009

16 December 2009

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Primary purpose	treatment
Enrollment	57
Start date	24 March 2008
Primary completion	16 December 2009
Estimated completion	16 December 2009
Sites	1 location across United States

Drugs / interventions tested

• Poly-ICLC

Conditions studied

• Influenza — all drugs for Influenza →
• Severe Acute Respiratory Distress Syndrome — all drugs for Severe Acute Respiratory Distress Syndrome →
• Smallpox — all drugs for Smallpox →
• Ebola — all drugs for Ebola →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with Influenza or Severe Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine the safety of an experimental medication called Poly-ICLC, developed for preventing or reducing the severity of infections from influenza and other viruses acquired through the nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels.

Healthy people between 18 and 70 years of age who have no chronic medical problems may be eligible for this study. Participants undergo the following procedures:

Part I

* Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests.
* Day 1: Nasal wash and Poly-ICLC administration. A small amount of salt water is placed into the front of the nose and then suctioned out. Poly-ICLC is then squirted into each nostril, one after the other, at a dose of 0.25, 0.5 or 1 mg. A small number of subjects are given a placebo (a solution with no active ingredient.) Subjects are observed in the clinic for 30 minutes after treatment.
* Day 2: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects.
* Day 5: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks.
* Day 12: Subjects are contacted by phone to review their diary card.
* Day 28: Subjects are contacted by phone to review their diary card.

Part II

* Up to 7 days before Poly-ICLC administration: Medical history, physical examination and blood tests.
* Day 1: Nasal wash and Poly-ICLC administration. Same as above for Part I participants.
* Day 3: Subjects receive a second dose of medication and are observed again for 30 minutes.
* Day 4: Subjects receive a second nasal wash and repeat blood tests. They keep a diary card for 1 week, recording any drug side effects.
* Day 7: Subjects have repeat blood tests and a review of their diary card. The keep a diary card for another 3 weeks.
* Day 14: Subjects are contacted by phone to review their diary card.
* Day 28: Subjects are contacted by phone to review their diary card.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting toll-like receptors: promising therapeutic strategies for the management of sepsis-associated pathology and infectious diseases.
   Savva A, Roger T. · · 2013 · cited 208× · PMID 24302927 · DOI 10.3389/fimmu.2013.00387
2. Therapeutic applications of nucleic acids and their analogues in Toll-like receptor signaling.
   Gosu V, Basith S, Kwon OP, Choi S. · · 2012 · cited 50× · PMID 23151919 · DOI 10.3390/molecules171113503
3. Mucosal delivery of tuberculosis vaccines: a review of current approaches and challenges.
   Stylianou E, Paul MJ, Reljic R, McShane H. · · 2019 · cited 43× · PMID 31876199 · DOI 10.1080/14760584.2019.1692657
4. Induction of Innate Immune Response by TLR3 Agonist Protects Mice against SARS-CoV-2 Infection.
   Tamir H, Melamed S, Erez N, Politi B, et al · · 2022 · cited 27× · PMID 35215785 · DOI 10.3390/v14020189
5. ANTIVIRAL COMPOUNDS IN THE PIPELINE TO TACKLE H1N1 INFLUENZA INFECTION.
   Beigel JH. · · 2010 · cited 4× · PMID 21738286 · DOI 10.1358/dof.2010.035.05.1487081
6. Involvement of nucleic acid-sensing toll-like receptors in human diseases and their controlling mechanisms.
   Lin YS, Chang YC, Pu TY, Chuang TH, et al · · 2025 · cited 3× · PMID 40495154 · DOI 10.1186/s12929-025-01151-9