Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100373
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2004-12-30
Brief Title:
RSV Challenge in Healthy Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None