N/A N=58 Basic Science

The Development of a Human Model of Respiratory Syncytial Virus Infection

Respiratory Syncytial Virus Infections · Respiratory Viral Infections

Bottom Line

View on ClinicalTrials.gov: NCT01349543 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcome: Primary: Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid — 23 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: RSV A Memphis 37 (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Oct 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid	23	—

Summary

The aim of this study is to understand the immune response (how the body fights infection) to Respiratory Syncytial Virus (RSV). This virus usually causes a simple 'common cold' illness in healthy adults, but can cause wheezing and lung problems in young infants and the elderly. The investigators want to understand why this is, in order to develop vaccines and treatments. Participants will include 30-40 healthy adults age 18-55 years. Study procedures will include brief medical exams, breathing tests, a diary of symptoms, blood tests, samples of fluid (lavage) and cells from the nose, throat and lungs. All participants will receive the virus via drops in the nose. The duration of the study for all subjects will be 6 weeks.

Eligibility Criteria

Inclusion Criteria

Healthy persons aged 18 to 55 years, able to give informed consent

Exclusion Criteria

Chronic respiratory disease (asthma, COPD, rhinitis, sinusitis) in adulthood
Inhaled bronchodilator or steroid use within the last 12 months
Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 6 months
Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
Smoking in the past 6 months OR >5 pack-year lifetime history
Subjects with allergic symptoms present at baseline
Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (>65 years), immunosuppressed persons, or those with chronic respiratory disease
Subjects with known or suspected immune deficiency
Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
History of frequent nose bleeds
Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
Pregnant or breastfeeding women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01349543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.