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

ConditionInfluenza
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorImperial College London

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

History of clinically significant/currently active conditions;

Cardiovascular, thromboembolic/cerebrovascular disease.

Types of chronic respiratory disease in adulthood.

Significant wheeze in the past

Trial design

Design model

Parallel

Treatments tested in this trial

  • FLUENZ

    Biological/Vaccine

    LAIV (Intranasal Influenza Vaccine)

  • Influenza challenge virus

    Biological/Vaccine

    Influenza challenge virus (H3N2 strain)

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: LAIVExperimental treatment 1 intervention
Group B: IAV ChallengeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
14 days
2

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

Time frame
14 days
3

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)

Time frame
14 days
4

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

Time frame
14 days

Secondary outcomes

1

To assess influenza viral dynamics in upper respiratory samples

To assess influenza viral dynamics in upper respiratory samples using Viral load by RT-PCR

Time frame
28 days
2

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

Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation

Time frame
28 days
3

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

To assess LAIV viral dynamics by RT-PCR in upper respiratory samples using Viral load by RT-PCR

Time frame
28 days
4

To assess antibody levels in blood before and after LAIV

Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator

Source ClinicalTrials.gov
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