RSV Challenge in Healthy Adults

NCT00100373 | Completed

• 1 other identifier: 04-035
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Infections, Acute; Respiratory Syncytial Virus

Keywords

Respiratory Syncytial Virus Infections

Interventions

RSV challenge material DRUG

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Rochester General Hospital

Rochester, New York, 14621, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 30, 2004
• First Posted: December 31, 2004
• Study Start: September 1, 2004
• Study Completion: May 1, 2005
• Last Updated: August 27, 2010

Record last verified: 2007-02

Locations

US (1)