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| ID | Type | Description | Link |
|---|---|---|---|
| MISP 59717 | Other Grant/Funding Number | MSD | |
| 57276 | Registry Identifier | CPMS | |
| 324970 | Other Identifier | IRAS |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteers | Experimental | Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV A Memphis 37 | Biological | RSV A Memphis 37 challenge agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal Viral Load | Mean nasal viral load by reverse transcription polymerase chain reaction (RT-PCR) reported in Log10 copies/mL | 28 days |
| Antibody Levels by Serum Neutralisation Assay | Antibody levels in blood by serum neutralisation assay by Log2 Geometric Mean Titre |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Chiu | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust | London | W12 0HS | United Kingdom |
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Healthy, non-smoking volunteers aged 65 - 75 years
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Volunteers | Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Volunteers | Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | adverse events | 28 Days |
|
|
from Day 0 to Day 180 (6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Volunteers | Healthy volunteers aged 65-75 years undergoing controlled human infection with RSV Memphis 37 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Christopher Chiu | Imperial College London | +44 20 3313 2301 | c.chiu@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2024 | Apr 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| 28 days |
| Antibody Levels by ELISA | Antibody levels in blood by Enzyme-linked immunosorbent assay (ELISA) by Log2 Geometric Mean Titre | 28 days |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 10 days |
|
|
|
| Secondary | Nasal Viral Load | Mean nasal viral load by reverse transcription polymerase chain reaction (RT-PCR) reported in Log10 copies/mL | Not Posted | 28 days | Participants |
| Secondary | Antibody Levels by Serum Neutralisation Assay | Antibody levels in blood by serum neutralisation assay by Log2 Geometric Mean Titre | Not Posted | 28 days | Participants |
| Secondary | Antibody Levels by ELISA | Antibody levels in blood by Enzyme-linked immunosorbent assay (ELISA) by Log2 Geometric Mean Titre | Not Posted | 28 days | Participants |
| 0 |
| 20 |
| 0 |
| 20 |
| 10 |
| 20 |
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Sore Throat | Infections and infestations | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Runny nose and cough | Infections and infestations | Systematic Assessment |
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| SARS-CoV-2 positive | Infections and infestations | Systematic Assessment |
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| Self Reported Cold Symptoms | Infections and infestations | Systematic Assessment |
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| Post-Operative Eye Pain | Eye disorders | Systematic Assessment |
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| Fatigue | Infections and infestations | Systematic Assessment |
|
| Tooth and gum infection | Infections and infestations | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| URTI | Infections and infestations | Systematic Assessment |
|
| Consitpation | Gastrointestinal disorders | Systematic Assessment |
|
| Body ache | Infections and infestations | Systematic Assessment |
|
| Shoulder Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Athroscopy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
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