Influenza in People With Normal and Weakened Immune Systems

Influenza viruses cause significant morbidity each year, and past epidemics and pandemics
have caused significant mortality. The impact influenza has or could have on the increasing
number of patients who are immunocompromised due to acute and chronic diseases as well as
immunosuppressive therapies is largely unknown. Limited information is available about the
innate immune response to influenza and how chronic illness and immunosuppression may affect
the immune response to the virus in comparison to that seen in normal hosts.

We will evaluate both immunocompromised and non-immunocompromised (control group) patients
from the local community, Washington Hospital Center, and the NIH Clinical Center. Patients
with known or suspected influenza will be evaluated by recording their symptoms, collecting
their blood and nasal specimens, and isolating their viruses. Each patient s infection will
be mapped by performing genomic analysis of the viral isolates collected during the patient s
infection (which will include analysis of sequences known to confer resistance to antiviral
medication), measuring cytokine levels in blood and nasal mucosal samples, and measuring
influenza-specific antibody responses. Correlation of these results with clinical symptoms
and clinical outcomes will be evaluated. Elucidation of these responses and the genomic
changes the virus may undergo during infection and treatment for influenza in both normal and
immunocompromised patients may help to better understand the impact influenza has on the
overall health of patients, as well as what strategies may be performed to better protect or
treat patients during the emergence of a new pandemic.

- INCLUSION CRITERIA:

Inclusion for Influenza Infected Group:

1. Greater than or equal to 2 years old

2. Patient or designated guardian able and willing to complete the consent/assent process
and be willing to comply with study procedures

3. Suspected of having influenza by clinical diagnosis or have a positive clinical
diagnostic test for influenza (rapid test or culture) within the past 2 months.

4. Agrees to undergo multiple nasal mucosal sample collections by nasal wash, swab,
and/or synthetic absorptive matrix (SAM)

5. Willing to have blood and nasal samples stored for future use

Inclusion for Healthy Pregnant Control Group:

1. Greater than or equal 13 years old

2. Patient or designated guardian able and willing to complete the consent/assent process
and be willing to comply with study procedures

3. Pregnant

4. Willing to have blood stored for future use

5. Have no signs or symptoms of a respiratory viral illness

EXCLUSION CRITERIA:

Patients will not be enrolled in this study if the following criterion applies or is
satisfied:

1. Any condition that, in the judgment of the investigator is a contraindication to
protocol participation or impairs a volunteer s ability to give informed consent.