Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study

Completed · Phase 1

Conditions studied: Influenza, Severe Acute Respiratory Distress Syndrome, Smallpox, Ebola, Unknown Respiratory Viruses

In brief

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.

Key facts

Study ID

NCT00646152

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

57

Starts

2008-03-24

Expected to finish

2009-12-16

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• A medical history that includes any of the following:
• Any chronic medical problem that requires daily topical nasal medications.
• Prior nasal or sinus surgery (including trans-nasal approaches of other organs such as pituitary).
• Allergic rhinitis, chronic sinusitis, or any other nasal inflammatory disease that requires daily intranasal or oral medication.
• Any chronic pulmonary conditions including (but not limited to) asthma, chronic obstructive pulmonary disease, and chronic bronchitis.
• Subjects with known hypersensitivity to interferons.
• Any other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase I drug (e.g. Patients with coronary heart disease, congestive heart failure, HIV, neuropsychiatric disorders, seizure disorder, autoimmune disease, hepatic decompensation, poorly controlled endocrine disorders (including poorly controlled diabetes, and actively hyper- or hypo-thyroid), hematological disorders (e.g. leukopenia, thrombocytopenia), ophthalmologic disorders (excluding errors or refractiveness) or other disorders for which symptoms of the condition could be similar to interferon-related toxicity or that might be exacerbated by interferon would be excluded. Patients with mild stable conditions, such as controlled hypertension, controlled diabetes, and osteoarthritis would be permitted to enroll.)
• Any history of habitual intranasal cocaine or other intranasal recreational drug use at any time, or experimental intranasal concaine or other intranasal recreational drug use within the last 10 years. (e.g. a 50 year old who tried cocaine once at age 20 is acceptable for enrollment).
• Women who are breast-feeding.
• Positive urine or serum pregnancy test.
• Participation in any research protocol that requires more than 100cc of blood to be given in any 6-week period of time.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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