Understanding RSV immunity in older adults
Novel Mucosal Correlates Of RSV Protection In Older Adults (A Controlled Human Infection Study With RSV in Older People)
This study looks at how older adults' immune systems respond to RSV compared to younger people to better understand how to protect them from the virus, especially now that RSV vaccines are available.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 65 Years to 75 Years |
| Sex | All |
| Sponsor | Imperial College London Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (London) |
| Trial ID | NCT06274619 on ClinicalTrials.gov |
What this trial studies
This study investigates how older adults' immune responses to respiratory syncytial virus (RSV) differ from those of younger individuals. It focuses on healthy volunteers aged 65 to 75 years to identify factors that influence the development of symptomatic RSV disease. The research aims to enhance understanding of the immune mechanisms at play in older populations, particularly in light of the recent approval of RSV vaccines. Participants will receive the RSV A Memphis 37 intervention to assess their immune responses.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 65 to 75 years who meet specific respiratory health criteria.
Not a fit: Patients with chronic respiratory diseases or recent upper respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prevention strategies and treatments for RSV in older adults, reducing morbidity and mortality associated with respiratory infections.
How similar studies have performed: While there have been studies on RSV in children, this specific focus on older adults and their unique immune responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
London
- Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Christopher Chiu — Imperial College London
- Study coordinator: Polly Fox
- Email: polly.fox@imperial.ac.uk
- Phone: +44 20 8383 3231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.