GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE
A Two-arm, Non-randomised, Open-label Experimental Medicine Study to Compare Immune Responses Between Healthy Volunteers Aged 18-55years Receiving Either an Intranasal Live-attenuated Influenza Vaccine or Viral Challenge With GMP Influenza A/Belgium/4217/2015 (H3N2)
Imperial College London
36 participants
Apr 16, 2025
INTERVENTIONAL
Conditions
Summary
This experimental medicine study aims to compare immune responses in healthy adult volunteers aged 18-55 years against influenza vaccination and infection in the upper and lower respiratory tract, following administration of a live-attenuated influenza vaccine delivered by nasal spray versus influenza A (H3N2) viral challenge.
Eligibility
Inclusion Criteria5
- Adults aged between 18-55 years inclusive
- Sero-suitable as defined by a serum micro-neutralisation titre <1:20
- Female participant who is not of child-bearing potential as assessed by an investigator OR is willing and able to use contraception as described in the protocol
- Male participants who are willing to use one of the contraception methods described in the protocol
- In good health with no clinically significant medical conditions
Exclusion Criteria30
- History of clinically significant/currently active conditions;
- Cardiovascular, thromboembolic/cerebrovascular disease.
- Types of chronic respiratory disease in adulthood.
- Significant wheeze in the past
- Respiratory symptoms including wheeze, resulting in hospitalisation
- Known bronchial hyperactivity to viruses
- Diabetes mellitus
- Migraine with associated symptoms like hemiplegia/vision loss. Cluster headache/migraine/prophylactic treatment for migraine.
- History of autoimmune disease/known immunodeficiency of any cause
- Immunosuppression.
- Known coagulation disorder/anticoagulant therapy
- Psychiatric illness including participants with a history of depression and/or anxiety with associated psychiatric comorbidities
- Other major disease that, under the PI's discretion, could interfere with the participant completing the study.
- Concurrent serious illness including history of malignancy that could interfere with the study or a participant completing the study.
- Known IgA deficiency/immotile cilia syndrome/Kartagener's syndrome
- Significant abnormality altering the anatomy/function of the nose or nasopharynx, a clinically significant history of epistaxis within the last 3 months, nasal/sinus surgery within 6 months of Day 0, including nasopharyngeal malignancy, arterio-venous malformation, or undiagnosed nasopharyngeal mass
- Inhaled bronchodilator/inhaled steroid use within the last 12 months before Day 0
- Acute upper respiratory tract infection in the past 6 weeks.
- 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 before Day 0
- Receipt of any vaccine within 30 days of Day -14
- Any significant medical condition/prescribed drug, under the PI's discretion
- Presence of cold-like symptoms and/or fever on Day -14 or Day 0.
- Receipt of blood/blood products/loss (including blood donations) of 550 mL or more of blood during the 3 months prior to Day -14.
- Significant history/presence of drug/alcohol misuse by self-report.
- Current use of drugs through nose inhalation or inhaled route including recreational drugs.
- Regular smoking and/or vaping and/or using nicotine-containing products in the past 3 months OR >5 pack-year lifetime history by self-report (5 pack years is equivalent to one pack of 20 cigarettes per day for 5 years).
- History of anaphylaxis and/or a history of severe allergic reaction or significant intolerance to any food/drug, as assessed by the PI.
- Clinically active rhinitis (including hay fever)/history of moderate to severe rhinitis/history of seasonal allergic rhinitis likely to be active at the time of inclusion into the study and/or requiring regular nasal corticosteroids on an at least weekly basis, within 30 days of enrolment.
- Anyone with any of the following contraindications to receiving the Fluenz Tetra Vaccine:
- Allergy to gentamicin, gelatin or the other ingredients of the fluenz vaccine.
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Interventions
LAIV (Intranasal Influenza Vaccine)
Influenza challenge virus (H3N2 strain)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06620185