Respiratory Tract InfectionsCHIRP01NCT06274619
Novel Mucosal Correlates Of RSV Protection In Older Adults
A study testing RSV A Memphis 37 in people with Respiratory Tract Infections, run by Imperial College London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- RSV A Memphis 37
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Mar 2024to 7 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust
London, W12 0HS
About this study
Official title: Novel Mucosal Correlates Of RSV Protection In Older Adults (A Controlled Human Infection Study With RSV in Older People)
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.
- Conditions
- Respiratory Tract Infections
- Being tested
- RSV A Memphis 37
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV A Memphis 37Biological
RSV A Memphis 37 challenge agent
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37 Receives: Biological: RSV A Memphis 37 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 Days
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
Measured: 10 days
Secondary outcomes (3)
Nasal Viral Load
Mean nasal viral load by reverse transcription polymerase chain reaction (RT-PCR) reported in Log10 copies/mL
Measured: 28 days
Antibody Levels by Serum Neutralisation Assay
Antibody levels in blood by serum neutralisation assay by Log2 Geometric Mean Titre
Measured: 28 days
Antibody Levels by ELISA
Antibody levels in blood by Enzyme-linked immunosorbent assay (ELISA) by Log2 Geometric Mean Titre
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start13 Mar 2024
- Primary completion7 Apr 2025
- Study completion7 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Chiu, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274619
- Sponsor's protocol ID
- 23HH8541
- Other IDs
- MISP 59717, 57276, 324970
- Acronym
- CHIRP01
- Status last verified
- Apr 2026
- First submitted
- 16 Feb 2024
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No