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: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Written informed consent
• Adult male or female aged between 18 and 55 years
• A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2
• In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety.
• Documented medical history
• Adherence to contraception requirements
• Serosuitable for the challenge virus.
Locations
Other Locations
United Kingdom
QMB
RECRUITING
London
Contact Information
Primary
Alex Mann
projectadmin@hvivo.com
+44(0)207 756 1300
Backup
Victoria Parker, MBBS
projectadmin@hvivo.com
+44(0)207 756 1300
Time Frame
Start Date: 2023-10-03
Estimated Completion Date: 2024-02-08
Participants
Target number of participants: 60
Treatments
Experimental: 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)
Experimental: Part A Dose Arm 2
Dose Arm 2: High dose, expected to be approximately 10\^7 TCID50/ mL (titer may be adjusted based on stock titer)
Experimental: Part B Dose Extension:
Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR
Experimental: Part B Dose Arm 3
Addition of a 3rd dose, TBD depending on outcome of Part A
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Hvivo