Influenza Clinical Trial
Official title:
Pilot Study of the Genotypic Analysis of Patients Infected With Influenza Virus Compared With Uninfected Spouse/Close Contact Controls
Influenza (the flu) is a leading cause of respiratory (breathing) illness that leads to sickness and death during the winter months. A better understanding of why certain people get the flu or get sicker with the flu than other people is important for developing improved vaccines and treatments. This study will look at the genetic makeup (determines each person's specific characteristics and traits) of 50 patients, older than 50, who were hospitalized with flu at Vanderbilt University during the 2006-2007 flu season. Their genetic makeup will be compared with the genetic makeup of 50 people who are not related but were in close daily contact with the flu patient and were not infected with flu virus. The study staff will collect a blood sample (contains genetic material) from each participant (flu patients and their contacts) for comparison. Flu patients will have completed a health survey as part of the previous study, and their contacts will complete a shorter version of this survey.
Status | Completed |
Enrollment | 6 |
Est. completion date | December 2008 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: 1. Male or female, aged greater than or equal to 50 years 2. For SUBJECTS: Enrolled in a Vaccine Treatment and Evaluation Unit (VTEU)-funded surveillance study conducted during the 2006 - 2007 influenza season [Division of Microbiology and Infectious Diseases (DMID) study 06-0051] 3. Residents of surveillance areas 4. For SUBJECTS: Persons who have been hospitalized with respiratory symptoms or fever and polymerase chain reaction (PCR) or culture confirmed influenza virus OR 5. For CONTROLS: Living with or in frequent contact with SUBJECT 6. For CONTROLS: Genetically unrelated to the SUBJECT 7. Willing and able to provide signature documentation of informed consent or parental permission Exclusion Criteria: 1. For SUBJECTS: Not enrolled in a Vanderbilt led respiratory disease surveillance study [Division of Microbiology and Infectious Diseases (DMID) study 06-0051] 2. For SUBJECTS: Receipt of blood products in the past 6 months 3. Anything in the opinion of the Investigator that would prevent the subject from successfully participating in this study 4. For CONTROLS: Influenza infection during the 2006-2007 flu season |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | phenotypic analysis | at analysis | No |
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