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OPEN FOR RECRUITMENT
Contact us
To get in touch with the study team, please email: imperial.humanchallenge@nhs.net or phone: 07872 850212
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 18-40 years receiving either an intranasal live-attenuated influenza vaccine or viral challenge with GMP influenza A/Belgium/4217/2015 (H3N2)
We are looking for healthy volunteers aged 18 - 40 years old to take part in the Germinate Study.
Initially, participants will attend for a pre-screening visit to assess their existing immunity to flu. If they meet our criteria, they may then be invited to the full screening visit. Participants who are eligible after screening will either join the vaccine arm and receive a flu vaccine, or they will join the challenge arm and be deliberately infected with the H3N2 flu virus.
The vaccine arm involves a baseline visit on Day -14 (14 days before) and Day -1 (one day before) the vaccination visit. After this, they will be required to attend outpatient follow up visits on Day 1 (one day after), Day 3 (3 days after), Day 7 (7 days after), Day 10, Day 14, Day 28, Day 90 and Day 180. Participants will undergo nasal biopsies OR bronchoscopies which will be explained in detail by the study team. Participants in the vaccine arm will be paid up to £1,205 for time and inconvenience.
The challenge arm involves a baseline visit on Day -14 (14 days before) the residential stay. Participants will be admitted to the residential facility on Day -1 (one day before) they are to be deliberately infected with the flu virus. Participants will then remain in the residential facility until Day 8 if they remain uninfected, or until Day 10 if they become infected with flu. After this, participants will return for follow up visits on Day 14, Day 28, Day 90 and Day 180. Participants will undergo nasal biopsies OR bronchoscopies which will be explained in detail by the study team. Participants in the challenge arm will be paid up to £2,735 for time and inconvenience.