Healthy Subjects Clinical Trial
Official title:
Observational Study of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat in HIV-1 Uninfected Adult Volunteers
The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS
P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,
well tolerated and immunogenic. The present study is intended to extend the follow-up of the
volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and
cellular immune response. The results of the present study will be key for the design of
future phase II trials, particularly for the definition of the optimal schedule for boosting
immunizations.
All individuals (20) will be enrolled in a 120-weeks observational study and monitored every
24 weeks for the following 3 years. During these visits, in addition to the hematological
and biochemical assessment, the anti-Tat specific humoral and cellular immune responses will
be evaluated.
n/a
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