Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613737
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Dose Safety and Pathogenicity of a New Influenza a H3N2 Challenge Strain
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
In Part A up to 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 eg Virus Dose 3
In Part A up to 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 eg Virus Dose 3
Detailed Description:
This is an exploratory study of an influenza AEngland77632022 H3N2 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 the influenza AEngland77632022 H3N2 challenge agent Each participant will remain in the study for approximately 4 months from screening to the last clinic visit
The study will consist of 2 parts in Part A of the study up to 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 additional participants may be enrolled into the optional Part B of the study and may be given Virus Dose 1 Virus Dose 2 andor another virus dose eg Virus Dose 3
The study is divided into three phases
1 Screening phase Screening will occur between Day -90 to Day -2-1
2 Quarantine phase Participants will stay in the quarantine unit for approximately 8 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 investigators discretion
3 Outpatient phase Following the conclusion of the quarantine phase participants will attend a Follow-Up visit approximately 28 days after they received the study virus Their symptoms will be reassessed and a complete safety examination performed
A total of up to 80 participants may be given the influenza AEngland77632022 H3N2 challenge agent Each participant will remain in the study for approximately 4 months from screening to the last clinic visit
The study will consist of 2 parts in Part A of the study up to 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 additional participants may be enrolled into the optional Part B of the study and may be given Virus Dose 1 Virus Dose 2 andor another virus dose eg Virus Dose 3
The study is divided into three phases
1 Screening phase Screening will occur between Day -90 to Day -2-1
2 Quarantine phase Participants will stay in the quarantine unit for approximately 8 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 investigators discretion
3 Outpatient phase Following the conclusion of the quarantine phase participants will attend a Follow-Up visit approximately 28 days after they received the study virus Their symptoms will be reassessed and a complete safety examination performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None