A Study of Protective Immunity Against RSV and Influenza in Experimental Human Challenge of Volunteers
Respiratory Syncytial Virus Infections, Influenza, Human
About this trial
This is an interventional basic science trial for Respiratory Syncytial Virus Infections focused on measuring Influenza, Respiratory Syncytial Virus Infections, RSV A Memphis 37
Eligibility Criteria
Inclusion Criteria:
- Healthy persons aged 18 to 55 years, able to give informed consent
Exclusion Criteria:
- Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
- Inhaled bronchodilator or steroid use within the last 12 months
- Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 6 months
- Acute upper respiratory infection or sinusitis in the past 6 weeks
- Smoking in the past 6 months OR >5 pack-year lifetime history
- 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, the elderly (>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 immunoglobulin A 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 for the study
- Pregnant or breastfeeding women
- Positive urine drug screen
- Detectable baseline haemagglutination inhibition titres against influenza challenge strains
- Influenza arm only: history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations
Sites / Locations
- National Heart and Lung Institute, Imperial College London
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
RSV A Memphis 37
Influenza A/California/04/2009
Half the participants will be inoculated with RSV Memphis 37 10(4) plaque forming units (PFU) in 1 milliliter (mL) 25% sucrose/Dulbecco's Modification of Eagle's Medium (DMEM) delivered by intranasal drops. They will then be monitored as in-patients for 10 days with daily clinical assessment and blood and respiratory tract sampling. Following discharge, they will be followed up for up to 6 months post-inoculation.
Half the participants will be inoculated with Influenza A/California/04/09 3.5x10(4) tissue culture infective dose 50% (TCID50) in 1 mL in Dulbecco's phosphate buffered saline (DPBS) delivered by intranasal drops. They will then be monitored as in-patients for 10 days with daily clinical assessment and blood and respiratory tract sampling. Following discharge, they will be followed up for up to 6 months post-inoculation.