Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04586673
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2020-10-01
Brief Title:
A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Phase I Dose Escalation Open Label Trial to Assess Safety and Immunogenicity of Candidate ChAdOx1- and MVA- Vectored Conserved Mosaic HIV-1 Vaccines Given Sequentially to Healthy HIV-1 Negative Adult Volunteers in Oxford UK
Status:
COMPLETED
Status Verified Date:
2023-08
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:
The object of the study is to assess the safety profile of candidate vaccines ChAdOx1tHIVconsv1 MVAtHIVconsv3 and MVAtHIVcnsv4 administered sequentially in healthy HIV-12 negative adult volunteers
In addition the study will assess the immune responses generated of the candidate vaccines ChAdOx1tHIVconsv1 MVtHIVconsv3 and MVAtHIVconsv4 administered sequentially in healthy HIV-12 negative adult volunteers
3 healthy HIV-1 negative adult volunteers will receive one vaccination of low dose ChAdOx1tHIVconsv1 A further 10 healthy HIV-1 negative adult volunteers will receive a higher dose of ChAdOx1tHIVconsv1 followed by one vaccination each of MVAtHIVconsv3 and MVAtHIVconsv4 4 weeks later
In addition the study will assess the immune responses generated of the candidate vaccines ChAdOx1tHIVconsv1 MVtHIVconsv3 and MVAtHIVconsv4 administered sequentially in healthy HIV-12 negative adult volunteers
3 healthy HIV-1 negative adult volunteers will receive one vaccination of low dose ChAdOx1tHIVconsv1 A further 10 healthy HIV-1 negative adult volunteers will receive a higher dose of ChAdOx1tHIVconsv1 followed by one vaccination each of MVAtHIVconsv3 and MVAtHIVconsv4 4 weeks later
Detailed Description:
None
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