GEneRating Mucosal Immunity After INfluenzA Infection and Vaccination in Lung and Lymphoid TissuE

Recruiting now · Not applicable

Conditions studied: Influenza

In brief

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.

Key facts

Study ID: NCT06620185
Run by: Imperial College London
People needed: 36
Starts: 2025-04-16
Expected to finish: 2026-07-31
Last updated by the study team: 2026-04-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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