Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333424
Status:
TERMINATED
Last Update Posted:
2012-06-13
First Post:
2006-06-01
Brief Title:
Thai Prophylactic HIV Vaccine Phase I Study
Sponsor:
Kirby Institute
Organization:
Kirby Institute
Study Overview
Official Title:
A Randomised Placebo-Controlled Double-Blind Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Candidate Prophylactic pHIS-HIV-AE DNA Prime and rFPV-HIV-AE Boost HIV Vaccination Strategy
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Vaccines safe but not immunogenic in 8 participants trial closed to further recruitment by the protocol steering committee DSMB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The development of a safe and effective vaccine for HIV is the subject of intensive world-wide research Various approaches are being investigated in monkey models and humans This is a randomized double-blind trial to evaluate the safety and immunogenicity of a candidate preventative human immunodeficiency virus HIV vaccine strategy in 24 healthy adult Thai volunteers with no identifiable risk behaviour for HIV-1 infection Volunteers will receive three priming vaccinations at weeks 0 4 and 8 pHIS-HIV-AE a DNA vector delivering AE clade HIV-1 genes This will be followed at week 12 by single boost vaccination rFPV-HIV-AE non-replicating recombinant fowlpox virus vector delivering the same HIV-1 genes Safety and immunological monitoring will continue to 52 weeks
Detailed Description:
None
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