RSV Challenge in Healthy Adults
|First Submitted Date ICMJE||December 30, 2004|
|First Posted Date ICMJE||December 31, 2004|
|Last Update Posted Date||August 27, 2010|
|Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00100373 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||RSV Challenge in Healthy Adults|
|Official Title ICMJE||Characterization of the Immune Response and Viral Shedding to Experimental Infection With Respiratory Syncytial Virus, Strain A-2, in Healthy Adults Ages 21 to 40 Years Old|
|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 virus may be useful in development of vaccines and treatments. Participants will include 20 healthy adults age 21-40. Study procedures will include drawing blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal mucus weight and nasal washes and swabs. All participants will receive vaccine via nose drops. Patients will participate in the study for about 2 months.|
|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. The causative factors associated with severe RSV disease in the elderly are not well understood. The contribution of viral load, host inflammatory responses and the cellular immune response to disease pathogenesis are unknown. A better understanding of these processes may be useful in the development of vaccines and therapeutics for RSV disease. Although the adult groups at highest risk for serious RSV disease are elderly and high-risk adults, we propose to use the challenge model in young healthy adults to determine optimal timing of specimen collection and the feasibility of performing certain tests before moving ahead to the target groups with natural infection. 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. Participants will include 20 healthy adults age 21-40. Study procedures will include drawing blood, urine samples, respiratory exams, vital signs and temperature, diary cards, nasal mucus weight and nasal washes and swabs. All participants will receive vaccine via nose drops. Patients will participate in the study for about 2 months.|
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Intervention ICMJE||Drug: RSV challenge material|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||May 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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)
|Ages||21 Years to 40 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00100373|
|Other Study ID Numbers ICMJE||04-035|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institute of Allergy and Infectious Diseases (NIAID)|
|Verification Date||February 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP