Ignite Creation Date:
2024-07-17 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478420
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-27
First Post:
2024-06-26
Brief Title:
COVID-19 Omicron BA5 Subvariant Dose Finding Infection Study
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Dose Finding Human Experimental Infection Study With SARS-CoV-2 Omicron BA5 Subvariant in Healthy Volunteers Immunologically Experienced Against SARS-CoV-2
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
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:
A phase 1 dose-finding open label clinical infection safety and viral detection optimization in healthy volunteers immunologically experienced against SARS-CoV-2
Detailed Description:
The aim of this phase 1 dose escalation study is to develop a safe human infection model with SARS-CoV-2 in healthy volunteers who have previously been vaccinated against SARS CoV-2 and either have been infected with SARS-CoV-2 and have evidence of this or have developed antibodies against SARS-CoV-2 Increasing titres of SARS-CoV-2 Omicron BA5 subvariant starting from 1x105 TCID50 up to 1x108 TCID50 will be administered intranasally to different groups of 5-7 volunteers This is in order to achieve a 50-75 attack rate as determined by two or more quantifiable qRT-PCR detections at two consecutive timepoints from 2 days post-challenge
A Data Safety Monitoring Board DSMB will review safety and quantitative virology data at each dose level and will recommend continuation dose escalation or de-escalation based on emergent data Dose escalation will take place in increments of up to 10 times the previous dose Once the optimal dose of SARS-CoV-2 Omicron BA5 subvariant has been identified in group 1 further inoculations in group 2 may proceed following DSMB review of infection rate viral load and clinical data Group 1 will enrol up to 28 participants whilst up to 24 participants will be enrolled into Group 2 across several sites
Rescue therapy with Paxlovid or alternative agents subject to local site availability eg Remdesivir will be administered to infected participants after any warning signs or symptoms of COVID-19 beyond mild disease
Volunteers with PCR positivity from 2 days post-challenge will remain in negative pressure isolation rooms within the clinical trials unit for a minimum of 14 days post-inoculation and until no viable virus is found in two consecutive samples and a negative or decreasing viral load is demonstrated by qRT-PCR Volunteers without PCR positivity from 2 days post-challenge will remain in negative pressure isolation rooms within the clinical trials unit for a minimum of 11 days post-inoculation
A Data Safety Monitoring Board DSMB will review safety and quantitative virology data at each dose level and will recommend continuation dose escalation or de-escalation based on emergent data Dose escalation will take place in increments of up to 10 times the previous dose Once the optimal dose of SARS-CoV-2 Omicron BA5 subvariant has been identified in group 1 further inoculations in group 2 may proceed following DSMB review of infection rate viral load and clinical data Group 1 will enrol up to 28 participants whilst up to 24 participants will be enrolled into Group 2 across several sites
Rescue therapy with Paxlovid or alternative agents subject to local site availability eg Remdesivir will be administered to infected participants after any warning signs or symptoms of COVID-19 beyond mild disease
Volunteers with PCR positivity from 2 days post-challenge will remain in negative pressure isolation rooms within the clinical trials unit for a minimum of 14 days post-inoculation and until no viable virus is found in two consecutive samples and a negative or decreasing viral load is demonstrated by qRT-PCR Volunteers without PCR positivity from 2 days post-challenge will remain in negative pressure isolation rooms within the clinical trials unit for a minimum of 11 days post-inoculation
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