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InfluenzaPhase 1NCT00646152

Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study

A Phase 1 study testing Poly-ICLC in people with Influenza and Severe Acute Respiratory Distress Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 nose, mouth and lungs. The study is divided into two parts, in which Poly-ICLC is tested at different dose levels. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Poly-ICLC
How many people
57 participants
Where
1 siteUnited States
Study dates
24 Mar 2008to 16 Dec 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Phase I Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate the Safety and Tolerability of Topical Nasal Poly-ICLC

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:

Read more

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.
Read 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 immunity, has been in extensive preclinical and investigational clinical therapeutic use as an intramuscular and intravenous compound, most recently in oncology applications. Only recently have the mechanisms of action been more fully elucidated, including induction of interferons, cytokines, and chemokines. Recognizing this, the infectious disease applications have been pursued in in vitro and animal models. Intranasal Poly-ICLC provides protection against mortality in animal models for multiple highly pathogenic viruses including influenza, severe acute respiratory distress syndrome (SARS), smallpox and Ebola. As its effects are not dependant on knowing the causative virus, an effective compound that could be protective against several unknown respiratory viruses has significant clinical appeal. While there is clinical safety data for intramuscular (IM) Poly-ICLC, no clinical studies of nasal application of Poly-ICLC have been done.

This study is a phase I safety and pharmacokinetic trial of nasally applied Poly-ICLC. Human volunteers will be administered increasing doses of nasal Poly-ICLC, with serial evaluation of safety, tolerability, as well as exploratory markers of immune activation.

Being tested
Poly-ICLC
Keywords
Antiviral, Influenza, Interferon, Prophylaxis, SARS, Healthy Volunteer, HV
Medical subject headings
Influenza, Human, Respiratory Distress Syndrome, Smallpox, Hemorrhagic Fever, Ebola

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Poly-ICLCDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of AE greater than or equal to grade 2 by subjects who receive drug

Secondary outcomes (1)

  1. Intranasal cytokines, nasal NO production, inflammatory cells in nasal wash

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2008 (estimated)
  2. Study start24 Mar 2008
  3. Primary completion16 Dec 2009
  4. Study completion16 Dec 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00646152
Sponsor's protocol ID
080093
Other IDs
08-I-0093
Status last verified
1 Jul 2014
First submitted
27 Mar 2008
Last updated
5 Jul 2018
Results posted
No

Publications

  • Dushoff J, Plotkin JB, Viboud C, Earn DJ, Simonsen L. Mortality due to influenza in the United States--an annualized regression approach using multiple-cause mortality data. Am J Epidemiol. 2006 Jan 15;163(2):181-7. doi: 10.1093/aje/kwj024. Epub 2005 Nov 30.

    PubMed 16319291

  • Hui DS, Sung JJ. Severe acute respiratory syndrome. Chest. 2003 Jul;124(1):12-5. doi: 10.1378/chest.124.1.12. No abstract available.

    PubMed 12853495

  • Shortridge KF. Severe acute respiratory syndrome and influenza: virus incursions from southern China. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1416-20. doi: 10.1164/rccm.2310005. No abstract available.

    PubMed 14668255

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Poly-ICLC in people with Influenza and Severe Acute Respiratory Distress Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of AE greater than or equal to grade 2 by subjects who receive drug. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00646152, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.

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