HIV Infections Clinical Trial
Official title:
A Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Infected Adult Volunteers
The development of a vaccine against HIV/AIDS 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.
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 400/mL and levels of plasma viremia < 50,000 copies/mL.
Study Design: Randomized, Double Blind, Placebo Controlled, Safety/Immunogenicity Study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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