Protocol Number: 07-I-0229

Title:

Influenza in the Immunocompromised Host

Number:

07-I-0229

Summary:

This study will evaluate how the immune system responds to influenza infection and compare how the infection differs in patients with a weakened immune system versus those with a healthy immune system.

Patients at the NIH Clinical Center who are older than 2 years of age and who are diagnosed with influenza A or B may be eligible for this study. Patients with healthy immune systems and weakened immune systems are included.

Participants answer questions about how they are feeling and have a physical examination to evaluate their symptoms. Blood and nasal fluid are collected on the first day and then every other day for a total of 8 days. Nasal fluid is collected by either inserting a small tube in the nose and washing the nose with salt water and collecting the fluid obtained, or by rubbing the inside of the nose with a swab. Physical examinations are repeated on the days that blood and nasal fluid are collected.

Sponsoring Institute:

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

1. Both males and females greater than or equal to 2 years old

2. Patient or designated guardian able to understand and sign the consent/assent form and willing to comply with study procedures

3. Must have a positive clinical diagnostic test for influenza (rapid test or culture) within two days prior to enrollment in the study

4. Must be able to safely undergo blood draws, except as exempted

5. Must be able to safely undergo multiple nasal swabs

6. Must be willing to have blood and nasal samples stored for future use

EXCLUSION CRITERIA:

Patients will not be enrolled in this study if any of the following criteria apply or are satisfied:

1. Patients who are unable to safely undergo study procedures and tests

2. Patients unwilling to have blood and/or nasal samples stored for future use

Special Instructions:

Currently Not Provided

Keywords:

Influenza Infection

Immunocompromised Host

Resistance Mutations

Prolonged Infection

Recruitment Keyword(s):

Influenza Infection

Condition(s):

Influenza, Human

Immunocompromised Host

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Allergy and Infectious Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Askonas BA, Lin YL. An influenza specific T-killer clone is restricted to H-2Ld and cross-reacts with Dk region. Immunogenetics. 1982;16(1):83-7.

Couch RB, Kasel JA, Gerin JL, Schulman JL, Kilbourne ED. Induction of partial immunity to influenza by a neuraminidase-specific vaccine. J Infect Dis. 1974 Apr;129(4):411-20.

McMichael AJ, Gotch FM, Noble GR, Beare PA. Cytotoxic T-cell immunity to influenza. N Engl J Med. 1983 Jul 7;309(1):13-7.

• 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 of Networks and Applications, CC.

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National Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/17/2008