Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505401
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
2007-07-20
Brief Title:
Phase I Safety and Immunogenicity Vaccine Trial Against HIVAIDS
Sponsor:
Istituto Superiore di SanitÃ
Organization:
Istituto Superiore di SanitÃ
Study Overview
Official Title:
A Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Infected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2007-07
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:
ISST-001
Brief Summary:
The development of a vaccine against HIVAIDS has been primary focused on the structural proteins Env Gag of HIV-1 with the aim of inducing sterilizing immunity by blocking virus entry Alternative approaches are focused on new vaccine strategies aimed at modifying the virus-host dynamic favouring the establishment of a long-term non-progressing disease status Such strategies target regulatory proteins that are the first to be expressed after infection and are essential for viral replication infectivity and pathogenesis Thus this approach may be effective for both preventive and therapeutic vaccination strategies
Detailed Description:
Being a very early viral regulatory protein necessary for viral gene expression cell-to-cell virus transmission and disease progression Tat represents a key target protein for the host immune response and an optimal candidate for such a vaccination strategy
Preclinical studies demonstrated that vaccination with a biologically active Tat protein is safe elicits a broad and specific immune response and induces a long-term protection against infection Cross-sectional and longitudinal studies in natural infection suggest that the presence of an anti-Tat humoral immune response correlates with asymptomatic infection and with a slower disease progression while the presence of CD8 T cell responses to Tat correlate with early virus control both in humans and monkeys Since the immunogenic regions of Tat are well conserved among the HIV-1 M group a vaccine based on Tat may be used in different geographic areas of the world
This Phase I study was directed at evaluating the safety profile as a primary end-point and the immunogenicity as a secondary end-point of the recombinant HIV-1 Tat vaccine in HIV-1 infected adult volunteers with mild immune deficiency Clinical category A according to CDC CD4 T cell counts 400mL and levels of plasma viremia 50000 copiesmL
Study Design Randomized Double Blind Placebo Controlled SafetyImmunogenicity Study
Preclinical studies demonstrated that vaccination with a biologically active Tat protein is safe elicits a broad and specific immune response and induces a long-term protection against infection Cross-sectional and longitudinal studies in natural infection suggest that the presence of an anti-Tat humoral immune response correlates with asymptomatic infection and with a slower disease progression while the presence of CD8 T cell responses to Tat correlate with early virus control both in humans and monkeys Since the immunogenic regions of Tat are well conserved among the HIV-1 M group a vaccine based on Tat may be used in different geographic areas of the world
This Phase I study was directed at evaluating the safety profile as a primary end-point and the immunogenicity as a secondary end-point of the recombinant HIV-1 Tat vaccine in HIV-1 infected adult volunteers with mild immune deficiency Clinical category A according to CDC CD4 T cell counts 400mL and levels of plasma viremia 50000 copiesmL
Study Design Randomized Double Blind Placebo Controlled SafetyImmunogenicity Study
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