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

NCT ID: NCT06620185

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-16
• Study Completion Date: 2026-01-06

Brief Summary

This experimental medicine study aims to compare immune responses in healthy adult volunteers aged 18-40 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

LAIV

Group Type: EXPERIMENTAL

FLUENZ

Intervention Type: BIOLOGICAL

LAIV (Intranasal Influenza Vaccine)

IAV Challenge

Group Type: EXPERIMENTAL

Influenza challenge virus

Intervention Type: BIOLOGICAL

Influenza challenge virus (H3N2 strain)

Interventions

FLUENZ

LAIV (Intranasal Influenza Vaccine)

Intervention Type: BIOLOGICAL

Influenza challenge virus

Influenza challenge virus (H3N2 strain)

Intervention Type: BIOLOGICAL

Other Intervention Names

Influenza vaccine; LAIV

Eligibility Criteria

Inclusion Criteria

• Adults aged between 18-40 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Chiu

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Polly Fox, MSc

Role: CONTACT

polly.fox@imperial.ac.uk

0208383 3231

Facility Contacts

Polly Fox

Role: primary

imperial.humanchallenge@nhs.net

Other Identifiers

23HH8514

Identifier Type: -

Identifier Source: org_study_id