Protocol Number: 08-I-0093

Title:

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

Number:

08-I-0093

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.

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.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Antiviral

Influenza

Interferon

Prophylaxis

SARS

Recruitment Keyword(s):

Healthy Volunteer

HV

Condition(s):

Influenza

Severe Acute Respiratory Distress Syndrome

Smallpox

Ebola

Unknown Respiratory Viruses

Investigational Drug(s):

Poly-ICLC

Investigational Device(s):

None

Interventions:

Drug: Poly-ICLC

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

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. Epub 2005 Nov 30.

Hui DS, Sung JJ. Severe acute respiratory syndrome. Chest. 2003 Jul;124(1):12-5. Review. No abstract available.

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. Review. No abstract available.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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