NCT06254820

Dose, Safety, and Pathogenicity of a New Influenza B Strain

An Exploratory Study To Establish The Dose, Safety, And Pathogenicity Of A New Influenza B Challenge Strain In Healthy Participants 18 To 55 Years Of Age

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Hvivo · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: 1. Screening phase: Screening will occur between Day -90 to Day -2/-1. 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.

Conditions

• Influenza B

Interventions

Type	Name	Description
BIOLOGICAL	influenza B/Connecticut/1/21 virus part a dose arm 1	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 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 b dose 1	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
BIOLOGICAL	influenza B/Connecticut/1/21 virus part b dose 2	Addition of a 3rd dose, TBD depending on outcome of Part A

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-02-02
• Completion: 2024-02-08
• First posted: 2024-02-12
• Last updated: 2024-02-12

Locations

1 site across 1 country: United Kingdom