GERMINATE
Research type
Research Study
Full title
GERMINATE: GEneRating Mucosal immunity after INfluenzA infection and vaccination in lung and lymphoid TissuE - A two-arm, non-randomised, open-label experimental medicine study to compare immune responses between healthy volunteers aged 18-40years receiving either an intranasal live-attenuated influenza vaccine or viral challenge with GMP influenza A/Belgium/4217/2015 (H3N2)
IRAS ID
347523
Contact name
Christopher Chiu
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
GERMINATE is a study to compare how immunity forms in the nose and lung following flu infection or vaccination by nasal spray. In this study, healthy volunteers aged 18-40 years will be given one or the other and we will take samples that will ultimately help our understanding of how to better prevent infection with flu. Participants who are deemed eligible to take part in this study will be non-randomly assigned to take part in either the Vaccine Arm or the Challenge Arm. We aim to recruit up to 12 participants in the Vaccine arm and 24 participants in the Challenge arm (36 in total). Participants in the Vaccine Arm of the study will be given a Live-attenuated influenza vaccine (LAIV) called Fluenz, which is administered by nasal spray. Participants in the Challenge Arm will be deliberately inoculated with an Influenza virus in the nose. After having been vaccinated, participants will be followed-up as outpatients for 6 months. After receiving the flu virus, they will remain in a quarantine unit until they are no longer infectious and then followed up for 6 months as outpatients. Samples from the blood, nose and in some individuals tissue from the lower airway by bronchoscopy or from the back of the nose will be taken. Resulting data will compare the immune responses when people get infected with influenza flu versus when they receive a nasal spray flu vaccine to better understand how future vaccines may be enhanced.
REC name
London - Fulham Research Ethics Committee
REC reference
25/LO/0034
Date of REC Opinion
22 Jan 2025
REC opinion
Favourable Opinion