NCT00100373

RSV Challenge in Healthy Adults

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (planned)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Infections, Acute
• Respiratory Syncytial Virus

Interventions

Type	Name	Description
DRUG	RSV challenge material

Timeline

• Start date: 2004-09-01
• Completion: 2005-05-01
• First posted: 2004-12-31
• Last updated: 2010-08-27

Locations

1 site across 1 country: United States