Status:
COMPLETED
Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Severe Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
Polyinosinic-Polycytidylic acid stabilized with polylysine and carboxymethylcellulose (Poly-ICLC), a stabilized double stranded RNA (dsRNA) therapeutic viral mimic activating innate and adaptive immun...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy volunteers age greater than or equal to 18 years and less than or equal to 70 years.
- For 2 months prior to study drug administration, and through the last day of follow-up (Day 28), subjects must agree to:
- Not take any topical nasal medications (prescription or over the counter).
- Not receive live attenuated influenza vaccine (Flumist) or any other live attenuated intranasal vaccine (licensed or research).
- Not receive any other investigational medications or vaccines.
- Females of child-bearing potential must agree to use one of the following methods of contraception for 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration:
- Be surgically sterile.
- Use oral contraceptives or other form of hormonal birth control including hormonal vaginal rings or transdermal patches.
- Use an intra-uterine device (IUD).
- Use (by ensuring her male partner(s) uses) barrier contraception (condom) with a spermicide.
- Any other equivalent (as judged by the investigative team) methods of contraception.
- EXCLUSION CRITERIA:
- 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.
Exclusion
Key Trial Info
Start Date :
March 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2009
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00646152
Start Date
March 24 2008
End Date
December 16 2009
Last Update
July 5 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892