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Author Topic: Iss: Aids vaccine from Italy?  (Read 7643 times)

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Offline newbie76

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Iss: Aids vaccine from Italy?
« on: July 06, 2008, 04:42:39 PM »
I was reading the news from back home and I came across this article about a research I had never heard of before.

 http://www.repubblica.it/2008/06/sezioni/scienza_e_tecnologia/aids-estrogeni/aids-vaccino-sicuro/aids-vaccino-sicuro.html?ref=search 

I will translate it for you and I'd be glad if anyone knows or has heard more about this very promising development.


The first studies on the Italian produced vaccine have not found any toxicity. Phase II of the experiments has now to test its "immunogenethic" (?)

AIDS, ISS' VACCIN IS "SAFE". THE TRIAL NOW ENTERS IN THE 2ND PHASE.

"The vaccine has been prooved safe so far" With these words full of satisfaction Barbara Ensoli, Director of the AIDS National Centre of the Superior Health Institute, announces the start of a new stage of the experimentations of a cure anti-AIDS. The first studies didn't reveal any toxicity, therefore the Italian vaccine branded ISS and containing the TAT protein can now enter Phase II. "The program starts these days -explains further Prof. Ensoli- we have recluted the first 128 Italians volunteers, all HIV positive individuals in treatment".

The Phase I studies on animals and on Humans haven't revealed any toxicity. The objective now is to test its "immunogenetic and keep on testing its safety, already tested in Phase I, through the monitoring and seriousness of side effects. "The results of Phase II are awaited within a year and, if everything goes well we will be able to move on to Phase III. The ISS initiative is the only public one of its type- If the vaccine was to pass Phase III, the further Phase would probably be privtely funded though".

"It's a great results -says Prof. Ensoli- other vaccines have already been used in Phase II and III and have failed in protecting from the infection. The formal tests that this vaccination can be an effective treatment agains the disease will only be performed in Phase III. In the mean time the only way to protect ourselves from catching HIV is by using condoms".
25th Apr 07: The worst day of my life
27th Apr 07: cd4 202 14%
30th Apr 07: cd4 126 18% VL 110000
19th May 07: Started Truvada/Sustiva
20th Jun 07: cd4 218 25% VL 435
13th Aug 07: cd4 374 20% VL 64
20th Dec 07: cd4 435 24% VL <50
20th Oct 08: cd4 725 31% VL <50
30th Nov 09: cd4 725 30% VL <50
01st Nov 10: cd4 755 33% VL<50
11th Nov 11: cd4 754 32% VL<50
01st May 12: cd4 864 40% VL<50
01st May 13: cd4 615 VL 609 :-/
14th May 13: VL <50

Offline Jake72

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Re: Iss: Aids vaccine from Italy?
« Reply #1 on: July 07, 2008, 11:49:34 AM »
Yes, and some of the initial results led to a court case in Italy:

http://www.i-sis.org.uk/ControversyAIDSvaccines.php

Here's more on the upcoming phase II study:

http://www.ansa.it/site/notizie/awnplus/english/news/2008-07-02_102217853.html

I could have sworn this already entered phase II for therapeutic use several years ago, but maybe not?

Offline newbie76

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Re: Iss: Aids vaccine from Italy?
« Reply #2 on: July 07, 2008, 01:04:30 PM »
Thank you Jake! Yes it's all very confusing. The first link seems to suggest that Phase II ended years ago, while my article and your 2nd one says that it's about to start...

It seems promising nevertheless though.
25th Apr 07: The worst day of my life
27th Apr 07: cd4 202 14%
30th Apr 07: cd4 126 18% VL 110000
19th May 07: Started Truvada/Sustiva
20th Jun 07: cd4 218 25% VL 435
13th Aug 07: cd4 374 20% VL 64
20th Dec 07: cd4 435 24% VL <50
20th Oct 08: cd4 725 31% VL <50
30th Nov 09: cd4 725 30% VL <50
01st Nov 10: cd4 755 33% VL<50
11th Nov 11: cd4 754 32% VL<50
01st May 12: cd4 864 40% VL<50
01st May 13: cd4 615 VL 609 :-/
14th May 13: VL <50

Offline John2038

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Re: Iss: Aids vaccine from Italy?
« Reply #3 on: July 07, 2008, 02:38:57 PM »
Thank you Jake! Yes it's all very confusing. The first link seems to suggest that Phase II ended years ago, while my article and your 2nd one says that it's about to start...

The first article, published on Oct 12th 07 says:
Ensoli says phase II therapeutic studies will start in Italy in the next few months..

And the second, published on July 2nd 08 says:
The second phase of testing for a ground-breaking Italian AIDS vaccine is about to get under way..

No contradiction here so far no ?  ;)

Offline John2038

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Re: Iss: Aids vaccine from Italy?
« Reply #4 on: July 07, 2008, 02:54:11 PM »
newbie76,

just thanks for this great article.

It sounds ground-breaking and as everybody, I hopes it will work.
Especially after what happen with the KP1461.

Among the positive things regarding this vaccine, I like especially to read that:

- It had shown a ''100% response to the vaccine by producing specific antibodies''.
- It adopts a new approach to fighting HIV, the virus that causes AIDS.
- By targeting tat-proteins her treatment might be effective against all strains of HIV.
- Studies of the vaccine on laboratory animals have shown the treatment could be a vital step forward in the fight against AIDS
(Not enough to conclude, but this step must be successful to continue, and it is successfull)
- It is in Phase II

I also like to read that Aiuti said he was ''surprised'' about the suit and I hopes Barbara Ensoli will win this trial.

Finger crossed, hoping great news in 6 months and 1 year.

Offline leit

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Re: Iss: Aids vaccine from Italy?
« Reply #5 on: July 07, 2008, 04:04:49 PM »
I could have sworn this already entered phase II for therapeutic use several years ago, but maybe not?

No. Usual bullshit, too bad!


Offline leit

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Re: Iss: Aids vaccine from Italy?
« Reply #6 on: July 07, 2008, 04:09:56 PM »
« Last Edit: July 07, 2008, 04:16:20 PM by leit »

Offline leit

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Offline John2038

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Re: Iss: Aids vaccine from Italy?
« Reply #8 on: July 07, 2008, 05:05:27 PM »
Thanks leit !

About the "2 parliamentary questions", they have been submitted by the Dr. Barbara Ensoli herself. Those questions are still open, so not that much can be says until a conclusion is made, as in any trial.

Regarding the others links, especially the http://www.hiv1tat-vaccines.info/clinical_studies.htm, they are well summarized in the links provided by newbie76 and Jake72.
That is:

Study results
When the studies were completed, the independent Committee for the evaluation of adverse events certified the safety of the vaccine in both HIV-negative and HIV-positive individuals. This certification confirmed that the primary and secondary end-points were fully achieved for both the preventive and therapeutic trials. All the reports were submitted to Regulatory Bodies.

The successful completion if this Phase I study has encouraged and supported the launch of Phase II trials to test the immunogenic capacity of Tat in a larger number of volunteers
A review of the history of the Tat-based vaccine, from basic science to preclinical studies and to completion of Phase I trials, has recently been published in an editorial of the "AIDS" journal (Barbara Ensoli, Valeria Fiorelli, Fabrizio Ensoli, Aurelio Cafaro, Fausto Titti, Stefano Butto`, Paolo Monini, Mauro Magnani, Antonella Caputo and Enrico Garaci - AIDS 2006, 20:2245-2261).


Sound go so far don't you think ?

Offline leit

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Re: Iss: Aids vaccine from Italy?
« Reply #9 on: July 08, 2008, 02:43:09 AM »
About the "2 parliamentary questions", they have been submitted by the Dr. Barbara Ensoli herself.

Are you joking, John? The two questions were submitted by groups of members of both the branches of the Italian Parliament because the whole Ensoli affair is far from clear!

Quote
Study results
When the studies were completed, the independent Committee for the evaluation of adverse events certified the safety of the vaccine in both HIV-negative and HIV-positive individuals.

This is controversial and is therefore included in the parliamentary questions.

Quote
A review of the history of the Tat-based vaccine, from basic science to preclinical studies and to completion of Phase I trials, has recently been published in an editorial of the "AIDS" journal

...And this is the "review from November 2006 [that] describes the development process but does not report on immunogenicity" to which the table at http://aidsinfonyc.org/tag/science/immunePipelineMay08.html refers.

Quote
Sound go so far don't you think ?

Judge for yourself...


Offline John2038

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Re: Iss: Aids vaccine from Italy?
« Reply #10 on: July 08, 2008, 06:52:41 AM »
You might be right but I haven't read that

My understanding is that she have open the case to protect her reputation  against accusations  that she felt to be unfounded

Until this trial end, nothing can be said.
you might be right, but it's too early  to conclude now I feel.


Otherwise, the phase IIa is starting

Offline NYCguy

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Re: Iss: Aids vaccine from Italy?
« Reply #11 on: July 10, 2008, 06:08:04 PM »
This is an ongoing saga, but I'm really glad to finally see some news.  Too bad it's been tied up in the courts so the phase II that was promised ages ago can finally begin.  There was another researcher (whose name I can't recall) who also had a similar promising vaccine that was the subject of the law suit and I wonder if anyone has heard about that?

In fall '06 there were rumors from Italian forums (lilachat) that early study participants had amazing results from this vaccine.  Let's hope it's true - presumably someone knows but as usual the news is slow to come out.

I'm also wondering what's happening with Gallo's Tat vaccine, who I believe had some negative comments about Ensoli's...
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline leit

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Re: Iss: Aids vaccine from Italy?
« Reply #12 on: July 11, 2008, 02:43:37 AM »
Too bad it's been tied up in the courts so the phase II that was promised ages ago can finally begin.

No courts, no lawsuits! Simply, the Italian Parliament has many doubts about the whole Ensoli affair, so some of its members have submitted parliamentary questions (see above).

Quote
There was another researcher (whose name I can't recall) who also had a similar promising vaccine

Maybe Gringeri??? He completely, and wisely, disappeared after a parliamentary question!

Quote
In fall '06 there were rumors from Italian forums (lilachat) that early study participants had amazing results from this vaccine.

Yes, TROLL "study participants" ("Xavier"???)!
The only "amazing results" of phase I were revealed by Dr. Ferdinando Dianzani: very seriuos adverse effects like facial paresis and muscular disorders [ http://banchedati.camera.it/sindacatoispettivo_16/showXhtml.Asp?idAtto=1062&stile=6 ].

Quote
I'm also wondering what's happening with Gallo's Tat vaccine

Gallo??? Not different from Gringeri and Ensoli.


Offline NYCguy

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  • Posts: 180
Re: Iss: Aids vaccine from Italy?
« Reply #13 on: July 14, 2008, 05:57:34 PM »
Leit
thanks for that great response and links!  Wish I could read Italian.  Are you saying the phase 1 results caused facial paralysis? I remember - perhaps it was Xavier - reading in Lilachat that there were several people who claimed to have been off meds for sometime after taking the TAT.  So why are they going to phase II if they are have severe side effects?

You are right - it was Gringeri I was thinking of.  Also, what do you mean Gallo not being different from Ensoli and Gringeri?
11/9/06 = #$%^&!
sometime early Dec 2006:
CD4 530 20%/VL >250,000 (&*$$%!!)
started Reyataz300mg/Norvir/Truvada 12-27-06.
1/30/07 CD4 540 30%/VL <400
4/07 CD4 600+ 33%/VL <50
6/9/07 CD4 720 37%/VL <50
10/15/07 CD4 891 (!) %? VL <50
1/2010 CD4 599 (37%) VL<50 (drop due to acute HCV)
9/2010 - looks like HCV is gone for good! And I'm finally drinking again, thank GOD
2013 - considering a switch to Stribild. but I love my Kidneys (but I hate farting all the time!)...
June 2013 - switched to Stribild.  so far so good...

Offline leit

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  • Posts: 236
Re: Iss: Aids vaccine from Italy?
« Reply #14 on: July 20, 2008, 03:49:07 AM »
Are you saying the phase 1 results caused facial paralysis?

Professor Ferdinando Dianzani, president of the ethical committee of Spallanzani hospital in Rome (one of the four centers where phase I was carried out), said that, not me! [ http://banchedati.camera.it/sindacatoispettivo_16/showXhtml.Asp?idAtto=1062&stile=6 ]
Anyway facial paresis, not paralysis (less serious).

Quote
I remember - perhaps it was Xavier - reading in Lilachat that there were several people who claimed to have been off meds for sometime after taking the TAT.

Not several people, but only "Xavier", a typical troll. And, above all, NO peer-reviewed publication by Ensoli so far [ http://aidsinfonyc.org/tag/science/immunePipelineMay08.html ].

Quote
So why are they going to phase II if they are have severe side effects?

Dr. Ensoli will account for this, and many other things, to the Italian Parliament (hope soon).

Quote
what do you mean Gallo not being different from Ensoli and Gringeri?

Words, words, words, money, money, money, beating about the bush and no results at all.


Offline Peter Staley

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Re: Iss: Aids vaccine from Italy?
« Reply #15 on: July 20, 2008, 09:08:38 AM »
Dear forums members:

This is a message I post from time to time as a general warning.  A few of our regulars in this Research Forum, notably John2038 and bimazek, have a tendency to view each potential new AIDS therapy as a possible cure.  Neither of them are on treatment, and neither is an "expert" in HIV research (in the opinion of our own experts at AIDSmeds.com).

They both over-hype every press release or early study they read about, and fail to keep things in proper perspective.  While the news above is certainly promising, it is way too soon for this level of optimism.  The history of AIDS research is littered with therapies that sound just as good at first, but don't pan out later in the larger clinical trials.

Please take their postings with a grain of salt.

Peter Staley
Founder
AIDSmeds.com

Offline newbie76

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Re: Iss: Aids vaccine from Italy?
« Reply #16 on: July 22, 2008, 02:05:47 PM »
Hello Peter,

Not too sure if you were referring about me on this occasion when taking about over-hyping every press release or early study.  :-[ I simply translated the Italian article because I was surprised no one had picked up on that in the forums.
25th Apr 07: The worst day of my life
27th Apr 07: cd4 202 14%
30th Apr 07: cd4 126 18% VL 110000
19th May 07: Started Truvada/Sustiva
20th Jun 07: cd4 218 25% VL 435
13th Aug 07: cd4 374 20% VL 64
20th Dec 07: cd4 435 24% VL <50
20th Oct 08: cd4 725 31% VL <50
30th Nov 09: cd4 725 30% VL <50
01st Nov 10: cd4 755 33% VL<50
11th Nov 11: cd4 754 32% VL<50
01st May 12: cd4 864 40% VL<50
01st May 13: cd4 615 VL 609 :-/
14th May 13: VL <50

Offline Peter Staley

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Re: Iss: Aids vaccine from Italy?
« Reply #17 on: July 22, 2008, 08:56:17 PM »
Nope -- not directed at you.

Offline leit

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Re: Iss: Aids vaccine from Italy?
« Reply #18 on: October 05, 2008, 10:08:14 PM »
More than THREE years later, MAYBE (I haven't bought the "fulltext" and the abstract tells nothing) she (Ensoli) has finally succeeded in publishing PART of the results ("therapeutic" arm only) of the PHASE I trial of her "vaccine": "The therapeutic phase I trial of the recombinant native HIV-1 Tat protein" [AIDS. 2008 Oct 18;22(16):2207-2209].

No comment.
« Last Edit: October 05, 2008, 11:57:00 PM by leit »

Offline simpleguy

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Re: Iss: Aids vaccine from Italy?
« Reply #19 on: December 29, 2009, 12:28:47 AM »
In between browsing for "entertainment" on the net ::) I found this:

Published sep. 2009, results of phase I
"<snip>... Vaccination with Tat induced a balanced immune response in uninfected and infected individuals. In particular, therapeutic immunization induced functional antibodies and partially reverted the marked Th1 polarization of anti-Tat immunity seen in natural infection, and elicited a more balanced Th1/Th2 immune response. Further, the number of CD4 T cells correlated positively with anti-Tat antibody titers. Based on these results, a phase II study is ongoing in infected drug-treated individuals."

http://www.ncbi.nlm.nih.gov/pubmed/20028332

I think it's this trial
http://clinicaltrials.gov/ct2/show/NCT00751595

I'm a bit confused because the first post in this thread is about the phase II trial - hmm!? Anyways - the description of the trail says it ongoing for 48 weeks, but it doesn't say anything about dates, e.g. a completion date. In theory the results of this trial could be in round this time next year, but wouldn't it be normal for a vaccine trial to have a long followup period of 2-3 years before safety and such would be known?
2008 JUL: Sustiva OCT: Rayataz DEC: Kaletra 2009 Off meds 2011 Intelence 2012+ Complera

Offline J220

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Re: Iss: Aids vaccine from Italy?
« Reply #20 on: December 31, 2009, 12:43:20 AM »
So I wrote to the contact shown on the clinical trial link (http://clinicaltrials.gov/ct2/show/NCT00751595) and received a reply directing me to this website which was published by the Italian National Institute of Health:

http://www.hiv1tat-vaccines.info/index.php

The drama and delays of the last few years aside, seems like they are in fact ready for Phase II and are actively recruiting, although only in Italy.

Specifically check the Clinical Trials link on the left side of the site, then click "read more" on the next page for more details on the phase II. Maybe finally we'll see this move!
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