A Phase 2 interventional study of influenza B/Connecticut/1/21 virus part a dose arm 1 and influenza B/Connecticut/1/21 virus part a dose arm 2 in Influenza B, sponsored by Hvivo. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-12.
Sponsored by Hvivo · Phase 2, Interventional, and Other
This is an exploratory study of an influenza B challenge strain to determine the optimum infectious titer of challenge agent in healthy participants 18 to 55 years of age.
This is an exploratory study of an influenza B 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 B 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:
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).
Exclusion Criteria:
Medium dose, expected to be approximately 10\^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)
Biological: influenza B/Connecticut/1/21 virus part a dose arm 1
Dose Arm 2: High dose, expected to be approximately 10\^7 TCID50/ mL (titer may be adjusted based on stock titer)
Biological: influenza B/Connecticut/1/21 virus part a dose arm 2
Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR
Biological: influenza B/Connecticut/1/21 virus part b dose 1
Addition of a 3rd dose, TBD depending on outcome of Part A
Biological: influenza B/Connecticut/1/21 virus part b dose 2
Medium dose, expected to be approximately 10\^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer)
High dose, expected to be approximately 10\^7 TCID50/ mL (titer may be adjusted based on stock titer)
Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR Dose Arm 3
Addition of a 3rd dose, TBD depending on outcome of Part A
Occurrence of AEs and SAEs
Measuring the occurrence of AEs and SAEs as assessed by CTCAE v4.0 during the first 28 days of treatment in \>/=40% of participants with laboratory confirmed infection.
Time frame: Day 0 - Day 28
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hvivo