The Development of a Human Model of Respiratory Syncytial Virus Infection

NCT01349543 | Completed Results DMC

• 1 other identifier: JROSM0127
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Syncytial Virus Infections; Respiratory Viral Infections

Keywords

Respiratory syncytial virus; RSV; Immunology; Viral infection; Bronchiolitis; Viral challenge; Viral lung disease

Outcome Measures

Primary Outcomes (1)

• Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid

  The host response to RSV challenge has been assessed at baseline, daily for 14 days and at study conclusion (28 days) using methods such as symptom diaries, volume of nasal secretions, numbers of inflammatory cells in nasal mucus, and levels of chemical mediators in nasal fluids.

  Prior to and 0-28 days post challenge

Study Arms (1)

Viral Challenge

EXPERIMENTAL

Biological: RSV A Memphis 37

Interventions

RSV A Memphis 37 BIOLOGICAL

Intranasal administration

Also known as: M37

Viral Challenge

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Wellcome Trust: collaborator

Study Sites (1)

St. Mary's Hospital, Imperial College London, Norfolk Place,

London, W2 1PG, United Kingdom

Location

Related Publications (1)

• Habibi MS, Thwaites RS, Chang M, Jozwik A, Paras A, Kirsebom F, Varese A, Owen A, Cuthbertson L, James P, Tunstall T, Nickle D, Hansel TT, Moffatt MF, Johansson C, Chiu C, Openshaw PJM. Neutrophilic inflammation in the respiratory mucosa predisposes to RSV infection. Science. 2020 Oct 9;370(6513):eaba9301. doi: 10.1126/science.aba9301.

  PMID: 33033192 RESULT

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Virus Diseases; Bronchiolitis

Interventions

beta-lactamase CTX-M-37, Salmonella enterica

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Infections; Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Results Point of Contact

• Title: Prof Peter JM Openshaw
• Organization: Imperial College London

p.openshaw@imperial.ac.uk

07973820801

Study Officials

• Peter Openshaw

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2011
• First Posted: May 6, 2011
• Study Start: May 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: September 1, 2014
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Locations

GB (1)