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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
LAIV (Intranasal Influenza Vaccine)
Influenza challenge virus (H3N2 strain)
Imperial Clinical Research Facility, Imperial College Healthcare NHS Trust
London, United Kingdom
RECRUITINGPeak 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
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
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
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
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)
Time frame: 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)
Time frame: 14 days
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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
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
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
To assess antibody levels in blood before and after LAIV
Antibody levels by ELISA, haemagglutination inhibition assay or microneutralisation
Time frame: 28 days