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

NCT06620185 | Recruiting DMC

• 1 other identifier: 23HH8514
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza

Keywords

LAIV; Challenge; Vaccine; Influenza; Flu

Outcome Measures

Primary Outcomes (6)

• Peak symptoms related to inoculation with a GMP-adherent influenza A (H3N2) virus in healthy adults aged 18-55

  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

  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

  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

  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

  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

  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 Outcomes (4)

• To assess influenza viral dynamics in upper respiratory samples

  28 days

• To assess antibody levels in blood before and after influenza challenge infection

  28 days

• To assess LAIV viral dynamics by RT-PCR in upper respiratory samples

  28 days

• To assess antibody levels in blood before and after LAIV

  28 days

Study Arms (2)

LAIV

EXPERIMENTAL

Biological: FLUENZ

IAV Challenge

EXPERIMENTAL

Biological: Influenza challenge virus

Interventions

FLUENZ BIOLOGICAL

LAIV (Intranasal Influenza Vaccine)

Also known as: Influenza vaccine, LAIV

LAIV

Influenza challenge virus BIOLOGICAL

Influenza challenge virus (H3N2 strain)

IAV Challenge

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Christopher Chiu

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Polly Fox, MSc

CONTACT

0208383 3231; polly.fox@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: April 16, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

GB (1)