Nasal Immune Challenge Study

A095696

Respiratory viral infections cause significant illness, especially in vulnerable individuals and is a topic of immense significance during the current COVID-19 global pandemic. Respiratory diseases such as asthma involve inflammation of the airways and viruses are a major cause of asthma attacks. The nose is easier to access than the lungs but has similar cells and is therefore useful to study immune responses throughout the respiratory tract. Rather than study the effects of a live virus on the immune system, it is possible to give a component or mimic of a virus to simulate an infection in a similar but more straightforward manner, without causing disease. In this study we will use a nasal spray containing a sterile substance called Resiquimod (also called R848) to mimic a viral infection. Resiquimod does not contain any living organisms and therefore there is no possibility of developing a real infection. Resiquimod works by binding to receptors in cells that line the inside of the nose (epithelial cells) as well as cells that can fight infection (immune cells). These cells respond to Resiquimod and cause mild inflammation in the nose, similar to a mild cold. We can then take samples to measure this response and investigate how it differs between individuals. This will help us better understand how the human immune system responds to viruses, and which cells and molecules the body uses to defend itself against infection.

2022-08-09

2024-09-30

2024-09-30

Recruiting

24

Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the study. * Male or female aged 18 years and above * Able (in the Investigators opinion) and willing to comply with all study requirements. * Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study. * Female participants of child-bearing potential and male participants whose partner is of child-bearing potential must be willing to ensure that they or their partner use effective contraception during the study * Participant has clinically acceptable laboratory and ECG at enrolment. * Negative lateral flow or polymerase chain reaction (PCR) test for SARS-CoV-2 * For healthy volunteers: * No clinical history of allergic rhinitis, asthma or eczema * Negative skin prick tests or specific IgE response to a panel of common aeroallergens: cat, dog, grass pollen, tree pollen, house dust mite, fungal spores * Normal blood eosinophil count (\< 300 cells/μL) * Normal baseline forced expiratory volume (FEV1) i.e. ≥80% * For volunteers with allergic rhinitis with or without asthma: * A clinical history of allergic rhinitis symptoms (sneezing, runny or itchy nose) in response to aeroallergens * At least one positive skin-prick test or specific IgE response to a panel of common aeroallergens: cat, dog, grass pollen, tree pollen, house dust mite, fungal spores * Pre-bronchodilator FEV1 ≥50% predicted * Participants are permitted to have physician-diagnosed mild to moderate asthma which is not poorly controlled as evidenced by an Asthma Control Questionnaire (ACQ-5) score of ≤1.5. * If they have asthma, they are permitted to be on inhaled corticosteroid (ICS) and a long-acting beta agonist (LABA), but no other controller medication. * Have had no other courses of medication including nasal and systemic corticosteroids, whether prescribed or over-the-counter, in the four weeks before first study dose other than mild analgesia, vitamins and mineral supplements or, for females, oral contraceptives. Exclusion Criteria: * Recent infections in past 14 days before screening: especially upper respiratory tract illnesses (including colds and influenza), sore throats, sinusitis, infective conjunctivitis. * Lower respiratory tract infection in past 28 days * Nasal anatomical defects, precluding use of nasal sampling techniques * The participant may not enter the study if any of the following apply: * Female participants who are pregnant, lactating or planning pregnancy during the study. * Respiratory diseases (other than hay fever or asthma where specified) * Significant medical history of hepatic, cardiovascular, gastrointestinal, renal, endocrine, infective, haematological, autoimmune, metabolic, rheumatological, neurological, dermatological or neoplastic conditions * Extreme obesity (BMI \>40) * Depression and psychiatric disorders * Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. * Participants who have participated in another research study involving an investigational product in the past 12 weeks * Smoking in previous 6 months

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}

2023-09-01