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T002: Phase II therapeutic trial with HIV-1 Tat vaccine candidate |
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| Published in PLoS ONE the results of the interim analysis of the Tat-based phase II therapeutic clinical trial (ISS T-002) on 87 HAART-treated patients. |
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| News Synopsis |
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During the last 20 years the use of antiretroviral drugs has changed the expectancy and quality of life of HIV-infected individuals. However, in spite of an effective viral-suppressing drug intervention, key signs of progression to AIDS such as the decline of CD4+ T cells and immune functions are only partially reverted by HAART, and are associated to a residual persistent immune activation. As a consequence, an increased risk of tumoral, cardiovascular, hepatic, renal and neurological diseases, as well as other clinical manifestations of accelerated aging, are now seen in HIV-treated disease.
The 48-weeks interim data analysis of the Tat vaccine phase II trial (ISS T-002, ClinicalTrials.gov NCT00751595), conducted in 87 patients under successful HAART has been published today in PLoS ONE. The results indicate that the Tat vaccine is not only safe and capable of inducing specific humoral (antibody) and cellular (T and B lymphocytes) immune responses, but it is also effective at significantly reducing the immunological alterations observed in HIV infection and still persisting during successful, viral-suppressing HAART.
In particular, as compared to non-vaccinated HAART-treated individuals, vaccinated HAART-treated subjects show a significant increase of the number and percentage of CD4+ T cells, B lymphocytes (which normally does not occur under HAART), and regulatory T cells. These increments are accompanied by the reduction of immune activation markers that are the hallmark of the residual persistent immune activation observed under HAART.
These findings suggest that the therapeutic vaccination with Tat may represent a novel and promising approach capable of reducing the immune dysregulation that persists even under successful HAART, with subsequent clinical benefit for the HAART-treated patients. Further, the more immune compromised patients appear to be the one benefiting the most from Tat vaccination.
The phase II study is still ongoing in Italy in 10 (now 11) clinical sites. Thanks to these favorable results, the sample size has been increased from 128 to 160 subjects to include also more immune-compromised individuals. Patients fulfilling the inclusion criteria will receive 3 or 5 intradermal administrations of the Tat protein given at monthly intervals in 2 different doses (7.5 µg or 30 µg).
PLoS (Public Library of Science) ONE is a peer-reviewed open-access web journal, founded in 2006 by eminent scientists including the Nobel Laureate Harold E. Varmus. PLoS ONE is supported by an Advisory Board of the highest international caliber, and it works through a novel review process that, after a strict and accurate pre-review by the Editorial board and the subsequent review by qualified, external referees, offers a post-review process that is open to the whole scientific community to share opinions and considerations in a real time fashion by using an on-line forum.
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| PLoS ONE Publication Click here to download .pdf |
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| Press release Click here to download .pdf |
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| Press Article Click here to download .pdf |
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| PPT Presentation Click here to download .pdf |
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| Italian News Coverage Click here to download .pdf |
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| International News Coverage Click here to download .pdf |
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| T002 Section Index. |
| What is T002 |
| Participating clinical centers |
| Protocol synopsis |
| Advisory Boards |
| Clinical trials publications |
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