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Author Topic: Therapeutic vaccines in trials  (Read 5861 times)

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Offline xman

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  • Posts: 286
Therapeutic vaccines in trials
« on: October 12, 2009, 04:23:37 PM »
The following is a list of current trials reguarding therapeutic vaccines. Some of them seems promising and are in advanced testing phases.

http://clinicaltrials.gov/ct2/results?term=hiv+therapeutic

Most interesting studies:

A5058s (phase II)
LC002 (phase I/II)
Dendritic cell vaccine (phase I/II)
Tat protein (phase II)
MRK Ad5 HIV-1 gag vaccine (phase II)
T cell vaccination (phase II)
DermaVir Patch (phase II)
DNA + HIV-rAd5 vaccine (phase II)
Remune and ALVAC (phase I/II)
Autologous HIV-1 ApB DC Vaccine (phase II)
Vacc-4x (phase II)

Gene therapies:

VRX496 (phase II)

Many trials are still ongoing which an outdated estimated completition date.

« Last Edit: October 12, 2009, 04:47:18 PM by xman »
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline georgep77

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Re: Therapeutic vaccines in trials
« Reply #1 on: October 12, 2009, 05:43:05 PM »
Many trials are still ongoing which an outdated estimated completition date.
Very interesting xman !!!
                   thanks for the info

                                :D
Come on Sangamo,  Geovax,  Bionor immuno, ...Make us happy !!!
+ 2008

Offline Inchlingblue

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Re: Therapeutic vaccines in trials
« Reply #2 on: October 12, 2009, 06:48:14 PM »
Thanks for the info xman.

There's also the ongoing zinc finger nuclease (ZFN) trial and the upcoming trials for the therapeutic vaccine from Dr. Yong Kang as well as Adaptimmune's engineered T-cells and a few others I can't think of right now.

« Last Edit: October 12, 2009, 06:50:21 PM by Inchlingblue »

Offline MYSTERY

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  • Posts: 186
Re: Therapeutic vaccines in trials
« Reply #3 on: October 12, 2009, 08:32:17 PM »
Xman,

Just so you know none of the trials that you mentioned will amount to anything. Its all just a waste of time.  ;D
Atheist don't believe in GOD, but GOD believes in them and loves them. Never let the failure of man conflict with your love of GOD.

Offline tash08

  • Member
  • Posts: 86
Re: Therapeutic vaccines in trials
« Reply #4 on: October 12, 2009, 09:25:58 PM »


Quote
Xman,

Just so you know none of the trials that you mentioned will amount to anything. Its all just a waste of time. 
MYSTERY,

your point of view is so negative ::), I believe in research. Of course you're entitled to your opinion, thereapeutic vaccine may not happen as soon as we would like to, but we are working on it.
01/04/06-HIV-
03/09/06-HIV+
05/07-Atripla
04/01/10 CD4-681, VL-UD
07/10/10 CD4-450, VL-UD
10/10/10 CD4-473, VL-UD
01/21/11 cd4-522, VL-UD
05/02/11 CD4-638, VL-UD <20 copies Hell yeah!
08/3/12 CD4-806, VL-UD

Offline WillyWump

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  • Posts: 7,185
Re: Therapeutic vaccines in trials
« Reply #5 on: October 12, 2009, 10:02:09 PM »
Whether it pans out or not AT LEAST they are trying. It's good to see this pipeline, you never know when they might stumble across something.

-Will
POZ since '08

Last Labs-
6/3/14 CD4- 736, UD 34%
6/25/13 CD4- 1036, UD,
2/4/13, CD4 - 489, UD, 28%

Current Meds: Prezista/Epzicom/ Norvir
.

Offline sensual1973

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  • Posts: 195
Re: Therapeutic vaccines in trials
« Reply #6 on: October 13, 2009, 03:55:17 AM »
it's always good to discuss ongoing trials,rather than theoritical assumptions and findings on paper only.
God grant me the serenity to accept the things i can not change.

Offline a2z

  • Member
  • Posts: 193
Re: Therapeutic vaccines in trials
« Reply #7 on: October 13, 2009, 10:39:19 AM »
Xman,

Just so you know none of the trials that you mentioned will amount to anything. Its all just a waste of time.  ;D

While there is a smiley at the end, I don't see how this post is funny.  Cynicism isn't needed... caution on the optimism, but not cynicism.

Even if every one of these trials failed, something is still learned.
Dates are blood draw dates:
5/23/14: CD4 895 --.-% VL UD - Truvada/Isentress
09/21/09: CD4 898 27.0% VL 120 - back on track, same meds.High level enzymes, but less so
06/15/09: CD4 478 21.8% VL 1150 - high liver enzymes... looks like I may not be resistant
05/22/09: Fixed insurance, resumed medicine
04/17/09: Ran out of medicine, could not resolve insurance problems
04/01/09: CD4 773 28% VL 120 - high liver enzymes
12/01/08: CD4 514 23% VL 630
10/17/08 started Reyataz, Norvir and Truvada. -- possibly minor neuropathy, but otherwise okay.
9/10/08: CD4 345 17%, VL > 78K
8/18/08: CD4 312 18%, VL > 60K (considering meds)
12/19/07: CD4 550 28% VL > 100K (no meds yet)
Diagnosed 10/23/07

Offline veritas

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  • Posts: 1,410
Re: Therapeutic vaccines in trials
« Reply #8 on: October 13, 2009, 10:58:14 AM »
it's always good to discuss ongoing trials,rather than theoritical assumptions and findings on paper only.

sensual1973,

I agree all avenues of HIV research should be pursued and discussed. We are in agreement -- so--

Let's discuss the ongoing trial of DermaVir patch. What was the methodology based on for this particular therapeutic ? Were there any adverse reactions in the phase1 study? Did the preclinicals show efficacy?
How often does this therapeutic need to be dosed? Questions for reflection in order  to know how it got this far. Without those answers it's a name on a list. What do you think we'll learn from this trial?

v

Offline MYSTERY

  • Member
  • Posts: 186
Re: Therapeutic vaccines in trials
« Reply #9 on: October 13, 2009, 12:24:44 PM »
While there is a smiley at the end, I don't see how this post is funny.  Cynicism isn't needed... caution on the optimism, but not cynicism.

Even if every one of these trials failed, something is still learned.

It is funny in the fact that I am giving Xman a little bit of a hard time because he normally is very skeptical on new research. I thought it was refreshing to see that he had some optimism regarding his listed trials. So once again  ;D ;D ;D.
Atheist don't believe in GOD, but GOD believes in them and loves them. Never let the failure of man conflict with your love of GOD.

Offline sensual1973

  • Member
  • Posts: 195
Re: Therapeutic vaccines in trials
« Reply #10 on: October 13, 2009, 12:28:55 PM »
who's funding those ongoing trials ?, what's the role of the leading economic countries on this ?
God grant me the serenity to accept the things i can not change.

Offline xman

  • Member
  • Posts: 286
Re: Therapeutic vaccines in trials
« Reply #11 on: October 13, 2009, 12:44:09 PM »
I tried to list all the trials of possible new treatments with at least a chance to be approved until 2015. The remaing studies and approaches and the trials in phase I were ignored since the timeline will likely be very long and we'll not see anything for 7-8 years at least. So in a sense of realism rather than optimism I'm trying to put the hope for a breakthrough in a correct perspective. Other studies like anti-ps are very incouraging but in my opinion too preliminary. Trials are ongoing but very slowly and nothing is currently in phase II.
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline NYCguy

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  • Posts: 180
Re: Therapeutic vaccines in trials
« Reply #12 on: October 13, 2009, 02:54:51 PM »
Thank you Xman. I love clinicaltrials.gov, but having someone do a bit of filtering can help put things in perspective.  Most interesting to me, was to find out that Barbara Ensoli's notoriously plagued (sorry - very bad pun) anti-tat vaccine is actually having a trial.  I had heard such great things about initial results when I first became infected three years ago, including postings on the old forums by a participant, that it seemed like a major breakthrough.  Then all hell broke loose politically in Italy and all information (and apparently trials) disappeared.  I would love to hear how this comes out as well as Gallo's tat vaccine which has been years in the making and I believe is also in trial, but I can't seem to find out anything about it.

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 veritas

  • Member
  • Posts: 1,410
Re: Therapeutic vaccines in trials
« Reply #13 on: October 13, 2009, 03:49:01 PM »

sensual1973,

Could you be more specific with your questions! Do you have any of the answers to my questions? What did you mean by "wanting to discuss"? Do you know how to do the research? or are you just looking for the "voila" so aptly put by another poster. There is no shame in not knowing the answer to research questions, but it's quite another to try to disparage other poster's interest especially when one doesn't have a clue as to the research going on. So again, if you want to discuss, start the dialogue.

xman,
What is the length of time needed for a therapeutic to go through all the phases of drug development?
So in your sense of realism and "correct" perspective, please explain to me how you decided that this list of therapeutics should/could be approved by 2015? That's 5yrs 2 1/2 months away. Are you saying it will take 5yrs 2 1/2 mos to complete phase 2 and phase 3 studies? Are you saying that 7 to 8 years is too long a wait for drug discovery?
By the way, anti-ps is finishing phase 2 for cancer and soon to enter phase 3. You realize that the MOA is the same for viral as cancer. Do you have any idea what that means?

Do you know the method of action for all the therapeutics on your list? How could those therapeutics be available sooner than the 5yrs 2 1/2 months?

Just questions to ponder. There is a lot more to it than posting a list. Finally, there are no guaranties so the more you understand about a particular therapy the better one's perspective will be.
Why not pick the therapy you feel most realistic about and follow it study by study for the benefit of all?
We could all post lists from clinical trials .gov, but if we don't know how these individual therapies are progressing, the list is just a computer exercise with very little meaning to those who do not know how to do the research.
xman, you get an A for effort because the list does have a purpose, but the follow-through is the meat of the research. This list will be forgotten if someone doesn't pick-up the ball and follow through on the therapy that interests them.

I hope you understand what I tried to do here.

v

Offline xman

  • Member
  • Posts: 286
Re: Therapeutic vaccines in trials
« Reply #14 on: October 13, 2009, 06:11:23 PM »
xman,
What is the length of time needed for a therapeutic to go through all the phases of drug development?

8 years on the average but it could be longer

Are you saying it will take 5yrs 2 1/2 mos to complete phase 2 and phase 3 studies?

many trials, in phase II, of the possible vaccines listed above are close to completition. phase III generally doesn't take more than 3 years.

By the way, anti-ps is finishing phase 2 for cancer and soon to enter phase 3. You realize that the MOA is the same for viral as cancer. Do you have any idea what that means?

theoretically yes but it still needs to be proven by facts and further studies. the results will tell us if you're right and i hope so. this would be a great day for everybody.

Do you know the method of action for all the therapeutics on your list? How could those therapeutics be available sooner than the 5yrs 2 1/2 months?

no i'm neither a scientist or a doctor and i don't want to know how this stuff works. what interests me more is that those approaches will definitely work. also it would be very time consuming explaining every single mechanism of the products studied. the trial pages have a description of the concept and how those approaches should work.

Just questions to ponder. There is a lot more to it than posting a list. Finally, there are no guaranties so the more you understand about a particular therapy the better one's perspective will be.
Why not pick the therapy you feel most realistic about and follow it study by study for the benefit of all?

no i consider all the possible approaches and not only one. you're a bit obsessed by anti ps and you think it will be a breakthrough. perhaps. as i said i really hope so. i'm not interested to demonstrate if i'm correct or wrong. i'm interested in finding studies and trials which have even a small chance to bring as benefits in a reasonable time. anti ps is theoretically a very promising approach but it needs to pass every trial phase to prove definitely its efficacy. now it's in phase I.

I hope you understand what I tried to do here.

v

sincerely i have some difficulties to understand that. as you recommended i opened my own thread because you don't accept critics in yours. this is not a competition to demonstrate who is right or wrong. as i said i don't care of that. you have probably a better scientific background as me but by logic sense something in phase II is closer to approval than something on paper or in early trials. i guess you don't need a degree in science to understand this.
« Last Edit: October 13, 2009, 06:32:16 PM by xman »
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline nycpoz

  • Member
  • Posts: 76
Re: Therapeutic vaccines in trials
« Reply #15 on: October 13, 2009, 07:05:52 PM »
thanks xman for the post. With so much research and new vaccines in the pipeline, cure is only few years away !!

Offline georgep77

  • Member
  • Posts: 148
Re: Therapeutic vaccines in trials
« Reply #16 on: October 13, 2009, 08:10:24 PM »
thanks xman for the post. With so much research and new vaccines in the pipeline, cure is only few years away !!
We share the same Hope nycpoz !!!
Thanks to everybody in this great forum for share ur research news & links with us
Come on Sangamo,  Geovax,  Bionor immuno, ...Make us happy !!!
+ 2008

Offline veritas

  • Member
  • Posts: 1,410
Re: Therapeutic vaccines in trials
« Reply #17 on: October 14, 2009, 09:22:20 AM »

xman,

I give you credit for trying to answer my questions and being honest with your replies as far as you understand them. I, also, now understand exactly what you are looking for -- specifically those drugs in development closer to completion of phase 3 with the possibility of success. As you stated, the method of action of the drug is not as important as it's ability to do the job. This is where we part company because the moa is very important to me (ie: the Berlin patient was cured of HIV with a bone marrow transplant which is very risky since about 30% of patients who have bone-marrow transplants die!).
I also threw you a curve in my questions concerning timelines because there really are none -- it depends on the parameters of the clinical trials which can certainly vary from trial to trial. Also, if a compound is working magnificently, phase 3 clinical trials can be halted and the drug can be submitted to the FDA for marketing.
Quite a few drugs fail in phase 3 studies, however, you are correct to say that a drug in phase 3 is closer to approval  than one in preclinicals or phase 1.
I would be estatic if one of the drugs on your list works. As I said before, I don't care where the cure comes from as long as it comes. I happen to be interested in anti-ps because it embraces a new paradigm in the fight against HIV, but I would gladly close my thread if a cure comes from another direction.


I won't ask you any more science questions and if I can contribute in a positive way to your posts I will.

Here's some information on the DermaVir patch --quite a few clinical trials going on:

http://www.geneticimmunity.com/GI05.html

v

Offline xman

  • Member
  • Posts: 286
Re: Therapeutic vaccines in trials
« Reply #18 on: October 14, 2009, 01:05:19 PM »
there's perhaps also a missinterpretation of definitions. it's a matter of syntax. the studies listed and the trials ongoing are looking for alternative treatments. therapeutic vaccines more likely don't have the potential to cure. anti ps probably has it and the fact that it is at least in phase I is certainly a very good sign. if they only would ask for fast track. they seem boosting more the cancer trials indeed. there's only one study that has the ambitious target of eradication currently in phase II.

therapeutic vaccines if able to boost immune response would give us the chance to avoid haart. they are not designed to cure us.

dermavir is an interesting concept but it moves too slowly.

the trials beyond the estimated completition date are interesting. it seems they have some proof of concept. otherwise they would terminate them due to the costs. any thoughts?
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline a2z

  • Member
  • Posts: 193
Re: Therapeutic vaccines in trials
« Reply #19 on: October 14, 2009, 01:06:52 PM »
It is funny in the fact that I am giving Xman a little bit of a hard time because he normally is very skeptical on new research. I thought it was refreshing to see that he had some optimism regarding his listed trials. So once again  ;D ;D ;D.

Okay, *that* made more sense.
Dates are blood draw dates:
5/23/14: CD4 895 --.-% VL UD - Truvada/Isentress
09/21/09: CD4 898 27.0% VL 120 - back on track, same meds.High level enzymes, but less so
06/15/09: CD4 478 21.8% VL 1150 - high liver enzymes... looks like I may not be resistant
05/22/09: Fixed insurance, resumed medicine
04/17/09: Ran out of medicine, could not resolve insurance problems
04/01/09: CD4 773 28% VL 120 - high liver enzymes
12/01/08: CD4 514 23% VL 630
10/17/08 started Reyataz, Norvir and Truvada. -- possibly minor neuropathy, but otherwise okay.
9/10/08: CD4 345 17%, VL > 78K
8/18/08: CD4 312 18%, VL > 60K (considering meds)
12/19/07: CD4 550 28% VL > 100K (no meds yet)
Diagnosed 10/23/07

Offline veritas

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  • Posts: 1,410
Re: Therapeutic vaccines in trials
« Reply #20 on: October 14, 2009, 06:19:42 PM »

xman,
I believe you are correct to say there is some proof of concept for the patch. These trials are too expensive to run on a whim and those monies could be used in other indications.
DermaVir is a nano-gene technology, certainly a new concept. That is why the trials are proceeding so slowly. They want to prove safety beyond any doubt and the information being evaluated is in anticipation of what the FDA will require for drug discovery. Remember the drug industry is global and many of these companies want approval from the global community by designing their trials to accommodate more than just the country where the drug was discovered ($$$$$$) in the shortest period of time.
A therapeutic vaccine can be designed to cure, however, a functional cure is the more probable outcome(especially for HIV). Anti-ps has the "potential " to cure, but I believe that lofty goal will have to come out of CHAVI using the more powerful anti-ps mabs that are currently in pre-clinicals. Looking to the cancer trials gives us proof of concept and also gives us some indication of anti-ps as a therapy.

Right now, the main premis to take away from all this research is the fact that a lot of research is being done to find a cure for this disease as Freewillie and Georgep77 and others have stated it is just a matter of time. It's Happening !!


v

Offline xman

  • Member
  • Posts: 286
Re: Therapeutic vaccines in trials
« Reply #21 on: November 27, 2009, 12:05:52 PM »
An interesting comment on the possibility to have a treatment breakthrough very soon (5 years or less) by Dr. Frascino from the thebody.com website. Very interesting but not encouraging. Dedicated to those here who still believe that I have a pessimistic view (and he even claims to be one of the most optimistic ones! LOL)

No cure or vaccine on the distant horizont. Really? (CURE 2009) (CURE 2009)
Nov 26, 2009

You are claiming many times that a cure or a vaccine is not even on the distant horizont and that we should'nt hope for a treatment break or change for the next years. I was reading about the phase II trials of Geovax for a preventive vaccine and the therapeutic gene therapy by Virxsys which both seems very promising. I guess you don't believe very much in this new approaches or you know something that we and the 2 companies don't know. On the therapeutic front Virxsys is not the only company currently in clinical trials. Several other candidates are in advanced testing phases. Why you say that a vaccine or cure is not feasible in the next 5 years?

 
 
 
Response from Dr. Frascino

Hi,

Actually, I'm probably one of the most optimistic people on the planet. However, I'm also a scientist. There are a number of vaccine trials ongoing. However, even a phase II trial is a very long ways away from being ready for primetime. That doesn't' mean we should't be hopeful or continue to work for a breakthrough. However, realistically speaking, when it comes to gene therapy, immune-based therapies and preventative or therapeutic vaccines, we are still a very, long way away from demonstrating efficacy and safety. After that, we will need to evaluate short- and long-term side effects and toxicities. Beyond that, there will be issues of cost and questions of how to globally administer these therapies.

My comments that neither a practical cure nor HIV preventative or therapeutic vaccine are on even the distant horizon remains accurate for the time being. (See below.) Stay tuned to The Body and we'll keep you posted as we make progress in these and other treatment and prevention efforts.

Dr. Bob


http://www.thebody.com/Forums/AIDS/SafeSex/Current/Q205304.html
 
sign the petition launched by the aids policy project addressed to the nih aimed to increase the money needed to find the cure:

http://www.aidspolicyproject.org/petition_for_the_nih

we can make a difference and we need to fight. please support them! it doesn't cost you anything. they need it now more than ever!

Offline sam66

  • Member
  • Posts: 277
  • Keep The Faith ; Fight The Fight
Re: Therapeutic vaccines in trials
« Reply #22 on: November 28, 2009, 05:43:26 AM »
 HOPE and OPTIMISM. the two most important drugs I use to fight this virus .
 things are getting better every day
december 2007 diagnosed +ve ,

 


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