Dose, safety & pathogenicity of a new influenza H1N1 challenge strain
Research type
Research Study
Full title
An exploratory study to establish the dose, safety, and pathogenicity of a new influenza H1N1 challenge strain in healthy participants 18-55 years of age
IRAS ID
316811
Contact name
Arun Anandakumar
Contact email
Sponsor organisation
hVIVO Services Ltd.
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
A total of up to 90 participants may be given H1N1 influenza challenge virus.
In Part A, 40 participants will be randomly allocated to one of two groups to be given one of two virus doses (Virus Dose 1 or Virus Dose 2).
Based on the outcome of Part A, participants in Part B, may be given Virus Dose 1, Virus Dose 2, or another virus dose (e.g., Virus Dose 3).
Each participant will remain in the study for about 4 months from Screening to the last clinic visit.
The study is divided into three phases:
1) Screening phase: Screening will occur between Day -90 to Day -2/-1. Historical generic screening data collected through the hVIVO generic screening process may be transferred to this study after the study-specific consent form has been signed by the participant.2) Quarantine phase: Participants will stay in the quarantine unit for approximately 11 days (from Day -2/-1 to Day 8).
One or two days prior to the day of inoculation with influenza challenge virus, participants will be admitted to quarantine where their eligibility will be reassessed. If participants remain eligible for the study, they will receive the challenge virus on Day 0. Participants will undergo a range of clinical assessments and safety monitoring for the entirety of their stay in quarantine. Participants will be discharged from the quarantine unit on Day 8 (or may remain longer at the principal investigator’s discretion).3) Outpatient phase: Final follow-up visit 28 days (±3 days) after the day they receive the virus. Their symptoms will be reassessed, and a complete safety examination performed.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0169
Date of REC Opinion
16 Aug 2022
REC opinion
Further Information Favourable Opinion