Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT06620185

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

Led by Imperial College London · Updated on 2026-04-20

36

Participants Needed

1

Research Sites

67 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

I

Imperial College Healthcare NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged between 18 and 55 years inclusive
  • Sero-suitable with serum micro-neutralisation titre less than 1:20
  • Female participants not of child-bearing potential or willing to use contraception
  • Male participants willing to use contraception methods described in the protocol
  • In good health with no clinically significant medical conditions
Not Eligible

You will not qualify if you...

  • History of significant or active cardiovascular, thromboembolic, or cerebrovascular disease
  • Chronic respiratory diseases or significant wheeze, including hospitalisation due to respiratory symptoms
  • Known bronchial hyperactivity to viruses
  • Diabetes mellitus
  • Migraine with associated neurological symptoms or prophylactic treatment
  • Autoimmune disease or known immunodeficiency
  • Immunosuppression or coagulation disorders
  • Psychiatric illness including depression or anxiety with comorbidities
  • Other major diseases that may interfere with study completion as judged by investigator
  • Serious concurrent illness or history of malignancy
  • Known IgA deficiency, immotile cilia syndrome, or Kartagener's syndrome
  • Significant nasal or nasopharyngeal abnormalities or recent nasal/sinus surgery
  • Use of inhaled bronchodilators or steroids within 12 months before Day 0
  • Acute upper respiratory infection within past 6 weeks
  • Use of systemic glucocorticoids or immunosuppressive drugs within specified timeframes
  • Receipt of any vaccine within 30 days before Day -14
  • Presence of cold-like symptoms or fever on Day -14 or Day 0
  • Blood donation or loss of 550 mL or more within 3 months before Day -14
  • History or presence of drug or alcohol misuse
  • Use of inhaled recreational drugs
  • Regular smoking, vaping, or nicotine product use in past 3 months or heavy lifetime smoking history
  • History of anaphylaxis or severe allergy to any food, drug, or fluenz vaccine ingredients
  • Active rhinitis or history of moderate to severe rhinitis likely to be active at enrollment
  • Allergy to gentamicin, gelatin, or other fluenz vaccine ingredients

AI-Screening

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Trial Site Locations

Total: 1 location

1

Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust

London, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

P

Polly Fox, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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