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

April 15, 2026 updated by: Imperial College London

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust
        • Principal Investigator:
          • Christopher Chiu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LAIV
Biological: FLUENZ
LAIV (Intranasal Influenza Vaccine)
Other Names:
  • Influenza vaccine
  • LAIV
Experimental: IAV Challenge
Biological: Influenza challenge virus
Influenza challenge virus (H3N2 strain)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55
Time Frame: 14 days
Peak self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up
14 days
Average duration of symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55
Time Frame: 14 days
Average duration of self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up
14 days
To confirm symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55 by Area Under the Curve
Time Frame: 14 days
Self-reported symptom scores by modified Jackson score from the viral challenge (Day 0) up to Day 14 follow-up (Area Under the Curve)
14 days
Peak symptoms related to inoculation with LAIV in healthy adults aged 18-55
Time Frame: 14 days
Peak self-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up
14 days
Average duration of symptoms related to inoculation with LAIV in healthy adults aged 18-55
Time Frame: 14 days
Average duration of self-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up (Peak, Duration, Area Under the Curve)
14 days
To confirm symptoms related to inoculation with LAIV in healthy adults aged 18-55 by Area Under the Curve
Time Frame: 14 days
Delf-reported symptom scores by modified Jackson score from the vaccination (Day 0) up to Day 14 follow-up (Area Under the Curve)
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess influenza viral dynamics in upper respiratory samples
Time Frame: 28 days
To assess influenza viral dynamics in upper respiratory samples using Viral load by RT-PCR
28 days
To assess antibody levels in blood before and after influenza challenge infection
Time Frame: 28 days
Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation
28 days
To assess LAIV viral dynamics by RT-PCR in upper respiratory samples
Time Frame: 28 days
To assess LAIV viral dynamics by RT-PCR in upper respiratory samples using Viral load by RT-PCR
28 days
To assess antibody levels in blood before and after LAIV
Time Frame: 28 days
Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Christopher Chiu, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23HH8514

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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