RSV Disease in the Elderly
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 99 |
| Updated: | 2/6/2019 |
| Start Date: | October 3, 2005 |
| End Date: | May 28, 2008 |
Pathogenesis of RSV Disease in the Elderly
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.
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.
Respiratory infections account for significant excess morbidity and mortality among older
people each winter. Influenza A virus and Respiratory Syncytial Virus (RSV) have emerged as
two of the most important viruses for this age group. The resultant morbidity and mortality
among these populations is substantial. Natural RSV infection in adults of various ages with
mild, moderate, and severe RSV disease will be evaluated in order to accomplish the following
primary objectives: to assess the effect of aging on the immune response to natural RSV
infection; to assess the effect of aging on the clearance of RSV infection; to assess the
effect of aging on the innate immune response to natural RSV infection; to assess the
possibility of virus spread to the lower airways and; to assess the role of the RSV-specific
immune response in the pathogenesis of severe disease. Study participants will include
approximately 2000 persons, male and female, greater than or equal to age 21, including
healthy persons, persons with common medical conditions (i.e., hypertension, diabetes,
thyroid conditions, arthritis, coronary artery disease, skin cancer, etc), persons with
underlying chronic pulmonary or cardiac conditions, and persons with signs and symptoms of
acute respiratory tract illness who reside in the Upstate, New York area. A prospective
cohort of ~800 persons will be recruited prior to the onset of RSV season in year one and
followed for respiratory illnesses during each RSV season for three years or until the
subject has a documented RSV illness. This group will contain persons of various ages and a
spectrum of medical conditions. This population will be used to evaluate age-related
differences in the immune response to RSV and viral shedding patterns.These volunteers are
expected to provide primarily cases of mild to moderately severe RSV disease. A second group
of subjects with signs and symptoms of acute respiratory tract illness will be recruited from
the Lifetime After hours Urgent Care Center, Rochester General Hospital emergency room and
inpatient medical service. Those identified with RSV infection will provide cases of moderate
to severe RSV disease. At the end of RSV season, a control group will be selected. This group
will be comprised from subjects chosen from the prospective cohort who did not have an RSV
infection during that winter season. Controls will be matched by age and underlying
conditions for each of the RSV infected subjects. The following outcome measures will be
assessed: RSV severity: severe disease=hospitalized cases, mild-moderate
disease=non-hospitalized cases; virus load: quantity and duration of RSV shedding as
determined by quantitative RT-PCR; T cell responses; antibody: acute serum IgG to RSV F and G
proteins by EIA and and neutralization titer to RSV A2 or B1 virus depending upon the
infecting strain; local innate immune response: maximum IL-6 or IL-8 or MIP-1 alpha levels in
nasal secretions; systemic innate immune response: maximum number of NK cells in the
peripheral blood; and systemic inflammation: maximum serum IL-6 or C reactive protein value.
people each winter. Influenza A virus and Respiratory Syncytial Virus (RSV) have emerged as
two of the most important viruses for this age group. The resultant morbidity and mortality
among these populations is substantial. Natural RSV infection in adults of various ages with
mild, moderate, and severe RSV disease will be evaluated in order to accomplish the following
primary objectives: to assess the effect of aging on the immune response to natural RSV
infection; to assess the effect of aging on the clearance of RSV infection; to assess the
effect of aging on the innate immune response to natural RSV infection; to assess the
possibility of virus spread to the lower airways and; to assess the role of the RSV-specific
immune response in the pathogenesis of severe disease. Study participants will include
approximately 2000 persons, male and female, greater than or equal to age 21, including
healthy persons, persons with common medical conditions (i.e., hypertension, diabetes,
thyroid conditions, arthritis, coronary artery disease, skin cancer, etc), persons with
underlying chronic pulmonary or cardiac conditions, and persons with signs and symptoms of
acute respiratory tract illness who reside in the Upstate, New York area. A prospective
cohort of ~800 persons will be recruited prior to the onset of RSV season in year one and
followed for respiratory illnesses during each RSV season for three years or until the
subject has a documented RSV illness. This group will contain persons of various ages and a
spectrum of medical conditions. This population will be used to evaluate age-related
differences in the immune response to RSV and viral shedding patterns.These volunteers are
expected to provide primarily cases of mild to moderately severe RSV disease. A second group
of subjects with signs and symptoms of acute respiratory tract illness will be recruited from
the Lifetime After hours Urgent Care Center, Rochester General Hospital emergency room and
inpatient medical service. Those identified with RSV infection will provide cases of moderate
to severe RSV disease. At the end of RSV season, a control group will be selected. This group
will be comprised from subjects chosen from the prospective cohort who did not have an RSV
infection during that winter season. Controls will be matched by age and underlying
conditions for each of the RSV infected subjects. The following outcome measures will be
assessed: RSV severity: severe disease=hospitalized cases, mild-moderate
disease=non-hospitalized cases; virus load: quantity and duration of RSV shedding as
determined by quantitative RT-PCR; T cell responses; antibody: acute serum IgG to RSV F and G
proteins by EIA and and neutralization titer to RSV A2 or B1 virus depending upon the
infecting strain; local innate immune response: maximum IL-6 or IL-8 or MIP-1 alpha levels in
nasal secretions; systemic innate immune response: maximum number of NK cells in the
peripheral blood; and systemic inflammation: maximum serum IL-6 or C reactive protein value.
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
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