Novel Mucosal Correlates Of RSV Protection In Older Adults (A Controlled Human Infection Study With RSV in Older People)

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Respiratory syncytial virus (RSV) is one of the most common causes of chest infection worldwide. Despite this, it remains an underappreciated health problem, with the first effective RSV vaccines only approved by the FDA in May 2023 and unlikely to be widely available for some time. Although RSV infection is most frequent in young children, most deaths occur in older adults, particularly in those with underlying heart and lung disease. This is believed to be due in part to the ageing immune system's reduced ability to protect against infection and symptomatic disease. However, little is known about the way human immune responses to RSV infection in older individuals differ from those of younger people. Further understanding of the mechanisms underlying immunity and potential impairments in these higher-risk people are therefore necessary. This project aims to study the factors that influence whether or not older people develop symptomatic RSV disease in healthy older volunteers after being given an RSV-induced common cold. Samples will be taken from the blood and nose in order to identify changes in the immune system associated with susceptibility or protection in older adults. Participants will be carefully screened to ensure there are no underlying health problems that might make them more at risk of severe disease and will be monitored closely throughout the course of infection. It is anticipated that differences in immune markers in the nose and/or blood of healthy older people will predict whether or not such individuals become infected or develop symptoms. By analysing the networks of genes that are switched on and off, the aim is to identify the pathways in the immune system responsible for these differences, to ultimately develop improved diagnostic tests, vaccines and treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 75
Healthy Volunteers: t
View:

• Healthy persons aged 65 to 75 years, able to give informed consent

• Non-smokers or ex-smokers with a pack year history of 10 or less

• Spirometry within the normal range for age and height (+/- 15%)

• Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) \>70% without bronchodilator

• Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the minimum of 4 weeks prior to screening

Locations
Other Locations
United Kingdom
Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust
RECRUITING
London
Contact Information
Primary
Polly Fox
polly.fox@imperial.ac.uk
+44 20 8383 3231
Time Frame
Start Date: 2024-03-13
Estimated Completion Date: 2026-02
Participants
Target number of participants: 20
Treatments
Experimental: Healthy Volunteers
Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37
Related Therapeutic Areas
Sponsors
Leads: Imperial College London

This content was sourced from clinicaltrials.gov