Novel Mucosal Correlates Of RSV Protection In Older Adults

Launched by IMPERIAL COLLEGE LONDON · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how older adults' immune systems respond to respiratory syncytial virus (RSV), a common cause of chest infections. Although RSV mostly affects young children, it can be very serious for older adults, especially those with heart or lung conditions. The researchers want to understand why some healthy older adults might get sick while others do not after exposure to RSV, which they will simulate by giving participants a mild cold. By looking at samples from their blood and nose, the study aims to find out which immune system factors help protect against RSV or make someone more likely to get sick.

To participate, individuals must be healthy adults aged 65 to 75, who have not smoked heavily and have normal lung function. They also need to have been vaccinated against COVID-19 at least four weeks before joining the study. Participants will be carefully monitored during the trial to ensure their safety. This research is important as it could lead to better ways to diagnose, treat, and even prevent RSV infections in older adults in the future.

Gender

ALL

Eligibility 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