Pilot Study of the Genotypic Analysis of Patients Infected With Influenza Virus Compared With Uninfected Spouse/Close Contact Controls

Influenza is a leading vaccine preventable cause of respiratory illness that leads to substantial morbidity and mortality during the winter months. It is defined by a rapid-onset systemic illness, with patients presenting with fever, chills, cough, myalgias, headache and sore throat. Given the huge health burden caused by influenza and the ever present threat of a future pandemic, a better understanding of population genetic variation and its association with severe outcomes from influenza infection is critical for developing improved vaccines and treatments for the entire population of at risk persons. This study is a single-center, specimen collection pilot protocol designed to compare the genotype of patients, aged greater than 50 years, who are hospitalized with respiratory symptoms or fever at Vanderbilt University with culture or PCR confirmed influenza virus infection with individuals who are not related but are in close daily contact with the subject and are not infected with influenza virus during the 2006 - 2007 influenza season. This study is linked to DMID protocol 06-0051. All subjects will be recruited from those subjects who have been enrolled in Division of Microbiology and Infectious Diseases (DMID) parent study 06-0051, a Vaccine and Treatment Evaluation Units (VTEU)-funded respiratory disease surveillance study conducted during the 2006 - 2007 influenza season. If the subject has completed the surveillance parent study, (DMID study 06-0051), then he/she must have agreed to be contacted for future studies on the surveillance consent prior to enrollment into this sub-study. Controls for this study will be recruited via the index cases. This study will enroll 100 subjects total, 50 study subjects and 50 control subjects. The 50 study subjects will include individuals hospitalized with respiratory symptoms or fever and infected with influenza virus. The 50 control subjects will be uninfected, non-related individuals living in the same household or in close daily contact with the subject. The study staff will obtain 15 ml venous blood sample from each subject for genotyping studies. Subjects will have completed a health assessment as part of the parent trial and controls will be asked a shorter version of this survey which includes items such as: demographics, chronic disease history, history of immunosuppressive drugs or conditions, vaccination history, smoking history, and living conditions. The primary objectives of the study are to conduct whole genome array analysis on individuals with confirmed influenza virus infection and to compare their genotype with individuals who were likely exposed to influenza due to close daily contact, but are not genetically related.