Novel Mucosal Correlates Of RSV Protection In Older Adults

Respiratory Tract Infections Clinical Trial

— CHIRP01  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274619
• Other study ID #: 23HH8541
• Secondary ID: MISP 59717572763
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: Polly Fox
• Phone: +44 20 8383 3231
• Email: polly.fox[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
• Inhaled bronchodilator or steroid use within the last 12 months
• Habitual use of any medication or other product (prescription or over the counter) for symptoms of rhinitis or nasal congestion within the last 3 months
• Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
• Participants with allergic symptoms present at baseline
• Clinically relevant abnormality on chest X-ray
• Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, clinically vulnerable and/or immunosuppressed persons, or those with chronic respiratory disease
• Participants 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
• Known Immunoglobulin A (IgA) deficiency, immotile cilia syndrome, or Kartagener's syndrome
• History of frequent nose bleeds
• Any significant medical condition or prescribed drug deemed by a study doctor to make the participant unsuitable for the study
• Recent or current use of recreational drugs, confirmed by a positive urine drug screen
• History of difficult blood draw, syncope or poor tolerance of sampling procedures

Related Conditions & MeSH terms

• Infections
• Respiratory Tract Infections

Intervention

Biological:
• RSV A Memphis 37
RSV A Memphis 37 challenge agent

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of solicited and unsolicited adverse events (AEs)	Number of solicited and unsolicited adverse events (AEs) from virus inoculation (Day 0) to Day 28 post-inoculation	28 Days
Primary	Infection rate	Infection rate calculated by the number of infected individuals over the number of uninfected individuals expressed as a percentage, with infection defined as 2 or more quantifiable greater than lower limit of quantification (viral load =LLOQ) by RT-PCR from nasal wash, reported on 2 or more consecutive timepoints, starting from Day 2 post-inoculation and up to discharge from quarantine	10 days
Secondary	Nasal Viral Load	Mean nasal viral load by reverse transcription polymerase chain reaction (RT-PCR) reported in Log10 copies/mL	28 days
Secondary	Antibody levels by serum neutralisation assay	Antibody levels in blood by serum neutralisation assay by Log2 Geometric Mean Titre	28 days
Secondary	Antibody levels by ELISA	Antibody levels in blood by Enzyme-linked immunosorbent assay (ELISA) by Log2 Geometric Mean Titre	28 days