Ignite Creation Date:
2024-07-17 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492564
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-07-05
Brief Title:
Dose Safety and Pathogenicity of SARS-CoV-2 Omicron Virus BA5
Sponsor:
Hvivo
Organization:
Hvivo
Study Overview
Official Title:
An Exploratory Study to Establish the Dose Safety and Pathogenicity of a SARS-CoV-2 Omicron Challenge Strain BA5 in Healthy Participants 18 to 30 Years of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 SARS-CoV-2 Omicron Challenge Strain BA5 in Healthy Participants 18 to 30 Years of Age
Detailed Description:
This is an exploratory study of an SARS-CoV-2 Omicron BA5 challenge strain to determine the optimum safe infectious titer of challenge agent in healthy participants 18 to 30 years of age
Up to 90 participants who meet all study inclusion and no exclusion criteria will be allocated to one of the three dose escalating cohorts Dose 1 Dose 2 or Dose 3 with up to 30 participants in each dose group to receive one dose of SARS-CoV-2 omicron Based on the outcome of each cohort the next cohort may receive a high or lower dose than the previous cohort
Each participant will remain in the study for approximately 9 months from screening 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
2 Quarantine phase Participants will stay in the quarantine unit for approximately 17 days from Day -2-1 to Day 14
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 14 or may remain longer at the principal investigators discretion If participants do not become infected with the virus they may be discharged earlier on Day 8
3 Outpatient phaseFollowing the conclusion of the quarantine phase participants will receive telephone follow up calls every 3 days between quarantine discharge and the day 28 follow up visit Participants will also attend additional Follow-Up visits approximately 28 days 90 days and 180 days after they received the study virus Their symptoms will be reassessed and a complete safety examination performed
Up to 90 participants who meet all study inclusion and no exclusion criteria will be allocated to one of the three dose escalating cohorts Dose 1 Dose 2 or Dose 3 with up to 30 participants in each dose group to receive one dose of SARS-CoV-2 omicron Based on the outcome of each cohort the next cohort may receive a high or lower dose than the previous cohort
Each participant will remain in the study for approximately 9 months from screening 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
2 Quarantine phase Participants will stay in the quarantine unit for approximately 17 days from Day -2-1 to Day 14
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 14 or may remain longer at the principal investigators discretion If participants do not become infected with the virus they may be discharged earlier on Day 8
3 Outpatient phaseFollowing the conclusion of the quarantine phase participants will receive telephone follow up calls every 3 days between quarantine discharge and the day 28 follow up visit Participants will also attend additional Follow-Up visits approximately 28 days 90 days and 180 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?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None