The Impact of Age on Adaptive Immunity in Adults Infected With Respiratory Syncytial Virus (NCT03728413) | Clinical Trial Compass
CompletedNot Applicable
The Impact of Age on Adaptive Immunity in Adults Infected With Respiratory Syncytial Virus
United Kingdom28 participantsStarted 2018-11-12
Plain-language summary
This study will for the first time systematically investigate the immune responses in an elderly cohort challenged with a well-defined RSV inoculum. With a global aging population and continuing difficulties in generating vaccines that can reliably induce protective immunity in the elderly, these data will indicate the targets at which development of vaccines against RSV and other infections should be directed.
Who can participate
Age range60 Years – 75 Years
SexALL
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Inclusion Criteria:
* Healthy persons aged 60 to 75 years, able to give informed consent
* Non smokers or ex-smokers with smokers with less than or equal to 5 pack years smoking history.
* Spirometry within the normal range for age and height (+/- 15%)
* FEV1/FVC \>70% pre-bronchodilator
Exclusion Criteria:
* Chronic respiratory disease (asthma, COPD, 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
* Subjects 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, other elderly adults (\>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
* Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome
* History of frequent nose bleeds
* Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable f…
What they're measuring
1
Number of Participants With Challenge-related Adverse Events