Dose, safety, and pathogenicity of a new influenza A H3N2 virus strain
Research type
Research Study
Full title
An Exploratory Study to Establish the Dose, Safety and Pathogenicity of a New Influenza A H3N2 Challenge Strain in Healthy Participants 18 to 55 Years of Age
IRAS ID
341061
Contact name
Alexandre Lima
Contact email
Sponsor organisation
hVIVO Services Ltd.
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
This is an exploratory study of an influenza A challenge strain to determine the optimum safe infectious titer of challenge agent in healthy participants 18 to 55 years of age.
A total of up to 80 participants may be given influenza A challenge virus.
The study will be conducted in 2 parts. 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 approximately 1 month from admission to quarantine 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 the 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
Wales REC 6
REC reference
24/WA/0090
Date of REC Opinion
27 Mar 2024
REC opinion
Favourable Opinion