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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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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:
Screening phase: Screening will occur between Day -90 to Day -2/-1. has been signed by the participant.
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Dose Arm 1 | Experimental | Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) |
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| Part A Dose Arm 2 | Experimental | Dose Arm 2: High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer) |
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| Part B Dose Extension: | Experimental | Extension of one of the Part A dose arms; which one is to be determined (TBD) depending on outcome of Part A, AND/OR |
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| Part B Dose Arm 3 | Experimental | Addition of a 3rd dose, TBD depending on outcome of Part A |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza B/Connecticut/1/21 virus part a dose arm 1 | Biological | Medium dose, expected to be approximately 10^6 tissue culture infective dose 50% (TCID50)/mL (titer may be adjusted based on stock titer) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 - Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Mann | Contact | +44(0)207 756 1300 | projectadmin@hvivo.com | |
| Victoria Parker, MBBS | Contact | +44(0)207 756 1300 | projectadmin@hvivo.com |
| Name | Affiliation | Role |
|---|---|---|
| Victoria Parker, MBBS | hVIVO Services Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QMB | Recruiting | London | E1 2AX | United Kingdom |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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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
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Participant and Investigator. Investigator will be blinded in Part A of the study.
| influenza B/Connecticut/1/21 virus part a dose arm 2 | Biological | High dose, expected to be approximately 10^7 TCID50/ mL (titer may be adjusted based on stock titer) |
|
| influenza B/Connecticut/1/21 virus part b dose 1 | Biological | 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 |
|
| influenza B/Connecticut/1/21 virus part b dose 2 | Biological | Addition of a 3rd dose, TBD depending on outcome of Part A |
|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |