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Tat Oyi vaccine trials to begin in 2007

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Jake72:
Thanks a lot for the info on anti-TAT, J.  I'd also heard the news that the Ensoli vaccine had surpassed phase I expectations and is entering phase II ahead of schedule.  I just wasn't sure whether the phase II trial had begun yet.

No resistance or side effects would certainly be great advantages for an anti-TAT vaccine.  We might also add 1) freedom from the issues (practical, emotional, and psychological) associated with round-the-clock pill therapy and, more importantly, 2) a lower cost, which would mean a real treatment option for the 95% of the world's HIV+ individuals who can't afford expensive HAART medications.

It wouldn't be wise to count any chickens before they hatch, but I am watching the anti-TAT scene with a lot of interest.

J220:
Another thing I remembered regarding Ensoli's trial, and this is something I read- although I cannot remember where. I think that for the phase two trials they are going to administer the vaccine to all volunteers, and not exclude a placebo group. This can only mean (to me) a confirmation that the vaccine is working, and they want to have as much data as possible to establish its efficacy accross the board.

And you are so correct, in terms of this type of vaccine being affordable/ accessible to everyone. As Loret's publication concluded:

1) The synthetic protein Tat Oyi is pharmacologically stable in solution for at least a period of one month, which is a requirement for mass vaccination....This vaccine could be also the only affordable therapy for millions of seropositive patients that have no access to antiretroviral treatment. J.

J220:

--- Quote from: Jake72 on June 03, 2006, 10:02:52 PM ---...it wouldn't be wise to count any chickens before they hatch, but I am watching the anti-TAT scene with a lot of interest.

--- End quote ---

Good advice, always. And I also am watching this with great intersest. I don't think people in general are aware of the significance of anti-Tat vaccines: without Tat there is no hiv replication, and, in the case of the macaques vaccinated with the Tat Oyi vaccine, no viral reservoir.

I'll add something else that Dr. Loret wrote to me:

The vaccine has the great advantage...to cure a patient with two or three injections instead to be dependent of a drug that you have to take every day.

This, of course, is said with the universal caveat of 'if it works', but judging from the preclinical in vitro tests, the tests in animal models (there have been at least two that I know of), and Ensoli's phase one results, there is every indication that it does.

Jake72:
It is interesting (and could be interpreted as encouraging) that the upcoming Ensoli trials will exclude a placebo group.  Where did you get this information?   I'm just curious because I haven't been able to find out much about the vaccine other than the press releases and what my very limited Italian has enabled me to gather from Lilachat.

Getting rid of viral reservoirs would be a great advantage, but I think that the first target should be getting people off HAART.  HAART has worked real wonders, but it's over a decade old, expensive, sometimes really inconvenient, and laden with side effects.  Most of us would readily admit that HAART is infinitely better than pre-HAART, but we need a better solution, and if anti-TAT is it, then more power to it.

And the sooner the better.   The Ensoli vaccine has been in development for longer than the TAT Oyi, so I think that priority efforts should focus on measuring the efficacy of the Ensoli vaccine and, if everything is all right, getting it to the people. 

J220:
I can't remember where I read about their (Ensoli's) plan to administer the vaccine to all subjects in the trial. I do know that it wasn't a forum, I believe it was an online article (journalistic). I'll try to see if I can find it again.

If you read lilachat.it regularly, you probably know that there was a person there, "Xavier", that participated in the trial. She said that the results so far for her and others, were "optimal", but that couldn't say more than that because apparently one of the conditions of the trial was that she would not give any public information on results.

She even said that if those in charge of running the trial found out that any volunteer was leaking information, they would exclude that person from the phase two. Talk about holding their cards close to their chest! Personally, I can't but interpret that as a good. And there's no question, a priority is to make haart obsolete, and it looks that a tat toxoid will do the trick.

A piece of trivia, not sure if I mentioned this before, but Ensoli was able to secure funding for her research from (among other sources) the IAVI. Dr. Loret also tried to secure funding from IAVI for his phase one trial, but since they had commited to Ensoli's project already they passed on Loret's. Dr; Loret also speculates that the IAVI probably felt that funding one tat vaccine was enough.

Oh another thing, that illustrates the structured and generally inflexible nature of the research business. If you read the publication regarding Dr. Loret's study- the link is an earlier post here-  you'll see that macaque number 966 was challenged twice. The decision to challenge (meaning to attempt to infect) that particular macaque twice was due to its astounding antibody response and the subsequent undetectability of the viral reservoir.

It was an opportunity to prove even further the efficacy of the Tat Oyi vacicne, and it did prove it. However, because the second challenge was not planned in the test protocol, when the results publication was submitted to Nature magazine it was rejected!

In any case, the research was ultimately published of course, and the results peer-reviewed. Ironically, Dr. Ensoli is considered somewhat of a maverick, to the point that she had a falling out with her mentor, Dr. Gringeri, I think, who was also pursuing his own anti-Tat vaccine. His results so far have been closely guarded, athough initial tests appear to have been less dramatic that Ensoli's. To make the divide even bigger between teacher and pupil, Ensoli is now the head of the health ministry in Italy!

So as you can see, there is apparently the makings of a bona-fide soap opera regarding anti-tat. Again, the fact that this is all centered upon a tat vaccine is encouraging. After all, who would compete so hard over something that had no potential?

I know I go on and on about Dr. Loret's research, but that is a function of the fact that his results which are very recent (10/05) are publically available and also because he has been kind enough to anwer all my questions. If only Dr. Ensoli would open up to the public as well...

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