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Sponsored by: |
Istituto Superiore di Sanita |
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Information provided by: | Istituto Superiore di Sanita |
ClinicalTrials.gov Identifier: | NCT00505401 |
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.
Condition | Intervention | Phase |
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HIV Infections |
Biological: recombinant HIV-1 Tat protein |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Infected Adult Volunteers |
Enrollment: | 27 |
Study Start Date: | December 2003 |
Arms | Assigned Interventions |
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A
Subjects were immunized subcutaneously with Tat, 3 dosage groups (7.5, 15 or 30 microgrammi), in association with Alum as adjuvant, or with Saline + Alum, as placebo.
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Biological: recombinant HIV-1 Tat protein |
B
Subjects were immunized intradermally with Tat, 3 dosage groups (7.5, 15 or 30 microgrammi), or with Saline, as placebo.
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Biological: recombinant HIV-1 Tat protein |
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/L and levels of plasma viremia < 50,000 copies/mL.
Study Design: Randomized, Double Blind, Placebo Controlled, Safety/Immunogenicity Study.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Italy | |
Hospital Spallanzani | |
Rome, Italy, 00149 | |
San Raffaele Hospital | |
Milan, Italy, 20132 | |
University of Rome "La Sapienza" | |
Rome, Italy, 00161 | |
San Gallicano Hospital | |
Rome, Italy, 00153 |
Study Director: | Barbara Ensoli, MD, PhD | National AIDS Center, Istituto Superiore di Sanità, Rome, Italy |
Study ID Numbers: | ISST-001 |
Study First Received: | July 20, 2007 |
Last Updated: | August 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00505401 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
HIV Tat protein HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |