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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
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The aim of this study is to understand the immune response (how the body fights infection) to Respiratory Syncytial Virus (RSV). This virus usually causes a simple 'common cold' illness in healthy adults, but can cause wheezing and lung problems in young infants and the elderly. The investigators want to understand why this is, in order to develop vaccines and treatments.
Participants will include 30-40 healthy adults age 18-55 years. Study procedures will include brief medical exams, breathing tests, a diary of symptoms, blood tests, samples of fluid (lavage) and cells from the nose, throat and lungs. All participants will receive the virus via drops in the nose. The duration of the study for all subjects will be 6 weeks.
Bronchiolitis is the commonest cause of hospital admission in infants. It is caused by Respiratory Syncytial Virus(RSV), a virus that causes mild 'common colds' in adults, but can cause lung inflammation and difficulty breathing in infants and the elderly. In 2005, nearly 34 million cases in children <5 years occurred, resulting in 3.4 million hospital admissions,and around 120,000 deaths. There is no vaccine, and some previous vaccines actually made the disease worse.
The investigators have been trying to understand why for 40 years. Advances in immunology have given us a completely different way of looking at inflammation: rather than studying what causes it, the investigators now want to know what regulates it. Much of what the investigators know about how what causes and regulates inflammation has come from studies of animals, however, these do not exactly predict what happens in man.
The investigators therefore plan to infect healthy adult volunteers with RSV, and observe what happens in humans after RSV infection. The investigators will collect samples of blood, fluid and cells from the nose, throat, and lungs, and a diary of symptoms over four weeks. The investigators will analyse the blood, fluid, and cells to determine the important mechanisms that regulate inflammation in human RSV infection.
Studies like this have been conducted previously with no severe side effects. The investigators anticipate that the discoveries made in this research project will help us achieve a better understanding of what causes and regulates inflammation in RSV so that the investigators can learn ways to control it, with the aim of developing vaccines and treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Viral Challenge | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV A Memphis 37 | Biological | Intranasal administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid | The host response to RSV challenge has been assessed at baseline, daily for 14 days and at study conclusion (28 days) using methods such as symptom diaries, volume of nasal secretions, numbers of inflammatory cells in nasal mucus, and levels of chemical mediators in nasal fluids. | Prior to and 0-28 days post challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Openshaw | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Hospital, Imperial College London, Norfolk Place, | London | W2 1PG | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33033192 | Result | Habibi MS, Thwaites RS, Chang M, Jozwik A, Paras A, Kirsebom F, Varese A, Owen A, Cuthbertson L, James P, Tunstall T, Nickle D, Hansel TT, Moffatt MF, Johansson C, Chiu C, Openshaw PJM. Neutrophilic inflammation in the respiratory mucosa predisposes to RSV infection. Science. 2020 Oct 9;370(6513):eaba9301. doi: 10.1126/science.aba9301. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Viral Challenge | RSV A Memphis 37: Intranasal administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Viral Challenge | RSV A Memphis 37: Intranasal administration |
| 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 | Host Response to RSV Challenge Measured as Change From Baseline of Chemical Mediators in Nasal Fluid | The host response to RSV challenge has been assessed at baseline, daily for 14 days and at study conclusion (28 days) using methods such as symptom diaries, volume of nasal secretions, numbers of inflammatory cells in nasal mucus, and levels of chemical mediators in nasal fluids. | Posted | Count of Participants | Participants | Prior to and 0-28 days post challenge |
|
|
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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 | Viral Challenge; Common Cold Symptoms | RSV A Memphis 37: Intranasal administration resulting in common cold |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof Peter JM Openshaw | Imperial College London | 07973820801 | p.openshaw@imperial.ac.uk |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| D014777 | Virus Diseases |
| D001988 | Bronchiolitis |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C515946 | beta-lactamase CTX-M-37, Salmonella enterica |
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| Participants |
|
| Sex: Female, Male | Sex was not used as a baseline measure. | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Assessed as healthy with no pre-existing disease | Count of Participants | Participants |
|
| Participants |
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
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| D007239 | Infections |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |