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

Sponsor: Imperial College London

NCT ID: NCT06620185

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
FLUENZ (biological), Influenza challenge virus (biological)
How long the study runs
Study runs about 15 months (dates as stated)
About the drug or intervention
FLUENZ — biological: LAIV (Intranasal Influenza Vaccine) · Influenza challenge virus — biological: Influenza challenge virus (H3N2 strain)
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
36
Started
2025-04-16
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for influenza
  • • NA - 36 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with influenza

Where?

  • • London - Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Influenza

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

What the study is looking for

  • ✓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...
  • ✓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
See the full criteria
Inclusion Criteria: * 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 Criteria * 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.

Where Is This Study? (1 UK site)

Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust

London W12 0HS, United Kingdom

Recruiting
Site contact (verified)
Christopher ChiuPrincipal Investigator

How to Get in Touch

Polly Fox, MSc

Sponsor contact

CONTACT

0208383 3231 polly.fox@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-04