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  Final results of the Tat-based phase II therapeutic clinical trial ISS T-002
The final results of the phase II trial indicated that Tat therapeutic immunization was safe and well tolerated. Most of the local and systemic adverse events were transient and of mild intensity. The vaccine was immunogenic since it induced durable antibody and cellular anti-Tat immune responses up to three years after Tat immunization.

The evaluation of efficacy biomarkers, performed as foreseen by the study protocol, showed that Tat immunization had durable effects on immune restoration and, of outmost importance, induced a significant decay of the virus reservoir (i.e. HIV proviral DNA) in the blood of patients under HAART, as compared to subjects under effective HAART enrolled in a parallel observational study used as reference group (ISS OBS T-002). These effects were greatest with Tat 30 µg, given 3 times and under Protease Inhibitors (PI)-based regimens, with a predicted 70% HIV-1 DNA decay after 3 years from vaccination and a HIV-1 DNA half-life of 88 weeks. HIV-1 DNA decay was associated with anti-Tat Abs capable of neutralizing Tat-mediated Env entry in target cells, and were predictive of HIV-1 DNA decay.

These results indicate that Tat is a key virulence factor and that anti-Tat immune responses are needed to restore immune homeostasis and to exert effective anti-viral responses capable of attacking the HAART-resistant virus reservoir. Thus, Tat immunization represents a promising pathogenesis-driven intervention to intensify HAART efficacy.

Interim analysis of the Tat-based phase II therapeutic clinical trial ISS T-002
PLoS ONE Publication Click here to download .pdf
Press release Click here to download .pdf
Press Article Click here to download .pdf
PPT Presentation Click here to download .pdf
Italian News Coverage Click here to download .pdf
International News Coverage Click here to download .pdf
 
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