More on the HIV therapeutic vaccine. (Spanish).

[blondbeauty]

Teresa Gallart is the designer of the vaccine. If you look at the grpah at the bottom, you will see HAART (Targa in Spanish) is taken during the 30 weeks of immunisation.

http://www.gtt-vih.org/LO+POSITIVO/LO+POSITIVO29/vacunas/

http://www.drogomedia.com/hemeroteka/archivos/200505177.pdf#search=%22teresa%20gallart%20vacuna%20vih%22

http://www.todoellas.com/contenidos/espanol/89/vacunacelulasdendriticas_3184.asp

A short Translation:

Dra. Teresa Gallart: In all vaccine there are two components: the antigen against which it is wanted to induce the immune answer, and adjuvant or the substance that facilitates that the answer is intense. In our case the antigen is the own inactivated virus of each person. The source of the virus has been the plasma obtained in great amount by means of plasmaféresis. The virus inactivates itself by heating, it is concentrated by means of centrifugalization of high speed and soon it is stored frozen until the moment of his use. Our adjuvant one is constituted by the dendríticas cells of the same person. These cells are obtained easily from the monocitos of the blood by means of a cellular culture of about a 6-7 days. Soon we faced them during other two days of culture the inactivated virus of the same person that we kept frozen. Later these "loaded" dendríticas cells with the antigen (inactivated virus)"are given back" to the person, by means of a simple subcutaneous injection near the armpit.

Dra. Teresa Gallart: The dendríticas cells are cells specialized in capturing the infectious agents and "processing them appropriately" so that lymphocytes T CD4 and CD8 can recognize and develop them a specific answer hard and effective against these agents. In fact, they are the "adjuvant physiological one" and most powerful than it is known. Although it is novel to do it in the field of the infection by VIH, therapeutic the vaccine use based on dendríticas cells comes making in numerous tests from antitumorlike inmunoterapia.

Dra. Teresa Gallart: The virus, when penetrating in the dendríticas, takes advantage of its work to propagate towards lymphocytes T CD4. For that reason usually one says that the dendríticas act like "Trojan horses". In addition, its functionality is damaged by the virus. This probably has much to do with the lack of optimal answer of the lymphocytes T that allows to control the infection. The vaccine tries to avoid such problems because the dendríticas cells that we prepared are infected and "we loaded them" with the inactivated virus that acts of noninfectivo antigen, reason why will induce an answer in lymphocytes T CD4 and CD8 against the virus without they transmit the infection.

Dra. Teresa Gallart: All the procedures of laboratory are made according to the criteria of Maxima clinical-biological, microbiological and pharmaceutical security (conditions of "Good you practice medical"). The inactivación of the virus exhaustive was verified. The virus, in addition, was the one of the same person who received the immunizations, and this person during the immunizations received TARGA. The test was approved by the Committee of Ethics and Clinical Investigation of the Hospital, as well as by the Spanish Agency of the Medicine like a clinical test with PEI (Product in phase of investigation). This type of approval by this Agency is very difficult to obtain, because as is logical they demand control of a very rigorous and strict clinical and biological quality.



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[Jake72]

Thanks very much, BlondBeauty.  That's very interesting.  I'm concerned about the concomitant HAART.  At some point can patients go off HAART indefinitely? 

If not, then how will researchers (or anyone else) know whether the virus is being controlled by HAART and/or the vaccine?  Plus, if patients are still on HAART, then they still have to deal with the costs, adherence issues, and side effects of the medication in addition to being immunized. 

Or is the vaccine being designed to allow patients to take fairly frequent structured treatment interruptions?

[blondbeauty]

Tha vaccine has been used in 18 patients. All of them had their viral load reduced between 80%-90% and four of them are undetectable.
They want to obtain a much more efficient vaccine in the following months. These are the results from October 2004. Much better results have been obtained recently.
Haart has to be interrupted prior to immunisation to let the viral load rebound to make the vaccine for every patient, because it is a custom made vaccine. Then HAART is continued during all the period of immunisation and stopped 6 weeks after the last vaccination.

[Jake72]

...stopped 6 weeks after the last vaccination-thanks, BlondBeauty, that's what I was curious about!

[blondbeauty]

Yes! Six injections in a 30 week period. 6 weeks after the last one, HAART is stopped. So the entire procedure lasts 36 weeks.

[J220]

It was actually 12 of the 18 that received the vaccination, the other 6 were controls. But the results are very promising, with a minimum VL reduction of 66%, and 4 of them having a "tenfold" reduction, i.e. to undetectable! In addition, they sustained the immune response up to 6 months after the shots.

The next phase should see more impressive results, given that it's going to be with a stronger version of the initial vaccine, which was more about safety than efficacy. So I will not be surprised if during the next phase all patients go down to undetectable. And after that, who knows?

Looking good!! Thanks for keeping us posted on this, BB.

[blondbeauty]

Oh yes! I made a mistake and mixed the french and the Spanish research. It was on the French trials were 18 patients were vaccinated.
Anyway they are waiting for the permission of the drug agency to keep on researching because, in Spain, dentritic cells are considered drugs...
But the results are  promising.
The complete procedure is:
* 1 year on HAART.
* 12 weeks without HAART to let the virus rebound.
* 70 weeks on HAART again to achieve a viral load under 20 copies per mililiter.
* 30 Weeks on HAART and vaccination.
* 6 weeks more on HAART after the last vaccination.
* HAART is stopped.
In total the treatment lasts 166 weeks. That is more than 3 years.

[Jake72]

And is that it?  No more HAART or vaccinations...ever? 

I wouldn't mind fairly regular vaccinations (with very minimal side effects), but...the sooner we can ditch HAART once and for all, the better!

Cheers,

Jake

[blondbeauty]

Who knows...Now they want to make the vaccine including all the strains of the virus each patient has and using a larger amount of dendritic cells so that no strain escapes from immunisation and manages to mutate.