Status:
COMPLETED
RSV Challenge in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Respiratory Infections, Acute
Respiratory Syncytial Virus
Eligibility:
All Genders
21-40 years
Phase:
NA
Brief Summary
The purpose of this study is to measure the immune response (how the body fights infection) to an experimental preparation of live Respiratory Syncytial Virus (RSV). A better understanding of this vir...
Detailed Description
Respiratory infections are a major cause of morbidity and mortality in the elderly. Recently, respiratory syncytial virus (RSV) has been shown to account for a significant portion of these illnesses. ...
Eligibility Criteria
Inclusion
- Healthy adults ages 21 to 40 years. Able to and has given informed consent to participate. Negative urine pregnancy test, if female. Pre-challenge serum neutralizing titer to RSV A2 by microneutalization (MNA) of \</= 1:657 (9.36 log2) Non-smoker No significant health abnormalities detected by evaluation of medical history, general physical examination, vital signs and laboratory tests.
- Willingness to remain in isolation for 11 nights and comply with all study requirements.
- Willingness to remain in the Rochester area for the 28 days of the study.
Exclusion
- Volunteers with any of the following conditions will not be eligible to participate:
- Chronic medical conditions requiring medical followup within the last 6 months. Serologic evidence of infection with HIV or hepatitis C virus, or presence of hepatitis B surface antigen in serum.
- History of medically documented asthma requiring treatment (including over-the-counter medications) at any time.
- Any abnormal laboratory results which would render challenge with RSV unsafe or interfere with the interpretation of the subject's response to challenge, e.g., AST, ALT, Bilirubin, BUN, creatinine. ( see Appendix II) Individuals requiring concurrent therapy with medications likely to interfere with evaluation of the response to infection, e.g. antipyretics, anti-inflammatory medications Close contact with children aged less than 2 years, with any individuals with significant immunosuppression, or with individuals greater than 65 years of age.
- Health care workers with any patient contact during the two weeks following challenge Pregnancy or uncertain status regarding pregnancy Acute respiratory infection or fever within 1 week of challenge Previous enrollment in a study evaluating RSV challenge viruses or RSV vaccines.
- Known glucose intolerance (history of abnormal glucose tolerance test or medical history of diabetes mellitus).
- History of chronic obstructive disease, emphysema or other serious or evolving pulmonary disease.
- Any condition in the opinion of the investigator might interfere with study objectives or pose excessive risks to subjects.
- History of previous hospitalization for a pulmonary condition (ie. Pneumonia, asthma, spontaneous pneumothorax, or severe sinus disease requiring a surgical procedure.
- History of frequent serious bacterial infections associated with low white blood cell count (below 4,000 per microgram)
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00100373
Start Date
September 1 2004
End Date
May 1 2005
Last Update
August 27 2010
Active Locations (1)
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1
Rochester General Hospital
Rochester, New York, United States, 14621