Respiratory Syncytial Virus Clinical Trial
Official title:
Pathogenesis of RSV Disease in the Elderly
NCT number | NCT00246480 |
Other study ID # | 05-0083 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 3, 2005 |
Est. completion date | May 28, 2008 |
Verified date | April 2011 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Respiratory syncytial virus (RSV) causes sickness and deaths in older people every winter. This study will investigate how aging affects the body's immune response (body's response to disease) to RSV. About 2000 people, age 21 and older, who reside in the upstate NY area, will be recruited. Two groups of subjects will be studied. The 1st group of volunteers will be recruited prior to the start of RSV season in year 1 of the study. These volunteers will include healthy people and people with various medical conditions. The 2nd group of volunteers will be patients admitted to Rochester General Hospital for acute respiratory illness. Procedures will include drawing blood from a vein in the arm (2 tablespoons), collecting nasal swabs, and collecting sputum. Volunteers may participate in study related procedures for up to 3 years.
Status | Completed |
Enrollment | 1401 |
Est. completion date | May 28, 2008 |
Est. primary completion date | May 28, 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility |
Inclusion Criteria: Prospective Cohort - Greater than or equal to 21 years of age - Able to provide written consent - Telephone contact available - Will reside in the Upstate New York area throughout the winter months Hospital Cohort - Greater than or equal to 21 years of age - Able to provide written consent or legal guardian able to provide written consent - Telephone contact available - Symptoms of respiratory tract infection for less than or equal to 30 days duration. Symptoms can be all or any of the following: nasal congestion, cough, new or increased sputum or dyspnea, sore throat, with or without fever Exclusion Criteria: Prospective Cohort - Known immunosuppressive condition including: HIV, active cancer currently receiving chemotherapy, hematological malignancy, autoimmune disorders. - Documented RSV infection in the previous year - Participation in previous RSV vaccine study Hospital Cohort - Known immunosuppressive condition including: HIV, active cancer currently receiving chemotherapy, hematological malignancy, autoimmune disorders. - Symptoms of a respiratory infection for longer than 30 days. - Participation in prior RSV vaccine study |
Country | Name | City | State |
---|---|---|---|
United States | Rochester General Hospital | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
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