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Sponsored by: |
Istituto Superiore di Sanita |
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Information provided by: | Istituto Superiore di Sanita |
ClinicalTrials.gov Identifier: | NCT00529698 |
This Phase I study is 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 healthy, immunologically competent adult subjects without identifiable risk of HIV-1 infection.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: Biologically active recombinant Tat protein |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat Protein in HIV-1 Uninfected Adult Volunteers |
Enrollment: | 20 |
Study Start Date: | January 2004 |
Arms | Assigned Interventions |
---|---|
A
Subjects were immunized subcutaneously with Tat, 3 dosage groups (7.5, 15 or 30 micrograms), in association with Alum as adjuvant, or with Saline + Alum, as placebo.
|
Biological: Biologically active recombinant Tat protein |
B
Subjects were immunized intradermally with Tat, 3 dosage groups (7.5, 15 or 30 micrograms), or with Saline, as placebo.
|
Biological: Biologically active recombinant Tat protein |
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.
The subjects were stratified in two Arms according to the administration route to receive 5 intradermal or subcutaneous immunizations at 4 weeks intervals.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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 Sanita, Rome, Italy |
Study ID Numbers: | ISSP-001 |
Study First Received: | September 13, 2007 |
Last Updated: | October 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00529698 |
Health Authority: | Italy: The Italian Medicines Agency |
HIV Tat protein Preventative vaccine |
Healthy volunteers HIV-1/2 uninfected HIV Preventive Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Healthy Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |