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Author Topic: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods  (Read 12267 times)

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Offline Inchlingblue

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New vaccine being tested to determine if individuals can go off ART for prolonged periods.  "Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period."

LINK:

http://clinicaltrials.gov/ct2/show/NCT00659789

Offline Matts

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Yes, it will be interesting, if the results of phaseII will be good and maybe Norway will bring the first therapeutic vaccine to the market.

Another thread: http://forums.poz.com/index.php?topic=22482.0

how the vaccine works:http://www.forskningsradet.no/servlet/Satellite?blobcol=urldata&blobheader=application%2Fpdf&blobheadername1=Content-Disposition%3A&blobheadervalue1=+attachment%3B+filename%3DS%C3%B8rensen.pdf&blobkey=id&blobtable=MungoBlobs&blobwhere=1224694353173&ssbinary=true

FAQs About the trial: Link
Jeff Hackman(bionor US) Youtube Video: Link YT

This is the next generation of Norways vaccines: "Vaccibodies" of the University of Oslo :http://www.vaccibody.com/index.php?option=com_content&view=article&id=51&Itemid=58
« Last Edit: May 05, 2009, 02:11:50 PM by Matts »
tivicay/kivexa

Offline Matts

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 Norway is running out of oil,but they want to get the world leader of biotechnology to maintain its first class of standard of living and social care. So they do alot (like other scandinavian countries e.g. sweden);to develop new approaches of curing and treating many Diseases of the world.

The Joint US-Norway Cancer (HIV) Research Program :http://noram.norway.com/article.aspx?lid=44&id=1156

Oslo Cancer cluster :.http://www.oslocancercluster.no/index2.php?option=com_docman&task=doc_view&gid=3&Itemid=39
« Last Edit: May 06, 2009, 08:35:40 AM by Matts »
tivicay/kivexa

Offline Inchlingblue

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Those are some excellent links Matts, thanks.

The new information as far as the latest clinical trials link for this vaccine is that they added more locations where the trials are being performed.

It would be great to hear from anyone who is in the study, although I guess they must all have to sign confidentiality agreements.

Offline RobGage

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #4 on: September 30, 2009, 10:49:05 AM »
Hi all,

I am in this trial and have been vaccinated.  The vaccinations were over a 4 month period.  As I recall, I received about 4 in the first two months, then one "booster" about 4 months in.  They also do a DHT test to see if there is a immune response and how significant it is.  This is a blinded placebo study, however it is obvious that I am in the active vaccine branch, as the injection sites and DHT sites puff up and get read for several days.  There is no way sterile water could mimic that.

So I will be going off meds in about three weeks but one thing of particular importance is how you are withdrawn from the meds: my primary doctor said that I need to stay sensitive to Atripla and just stopping abruptly can cause resistance issues, so I am switching to Combovir and Kaletra for 10 days before stopping altogether.  Then someday I can go back on the Atripla with no issue.  I sure hope this works for me, as the Atripla gives me problems, and I'd would love to be able to take the break for a few years.

Rob

Offline Inchlingblue

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #5 on: September 30, 2009, 01:14:53 PM »
RobGage: wow, that sounds great....I hope you can keep us posted on your progress.

One thing I don't get: if someone in the study is getting the placebo then they can't go off their meds, right? I guess the have to "unblind" it at that point to determine who goes on treatment breaks?
« Last Edit: September 30, 2009, 07:26:29 PM by Inchlingblue »

Offline RobGage

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #6 on: September 30, 2009, 04:10:06 PM »
It is double blinded and all participants (even placebo branch) will go off meds.  The study monitors VL & CD4, etc. very closely and if VL hits a certain level, or CD4 drops below a certain level, then you go back on meds.  The study is being very closely watched by international monitors because of the potential bad consequences of going off meds.  Every thing they do to me, a witness has to be in the room signing off on it.  Also, getting into the study is not easy as you have to have all your blood paperwork over the years, and they even verified it with my primary doctor.  There were lots of other restrictions too, such as age, VL, CD4, time on HAART, and more.  I keep this forum posted over the next few years on this study.

Rob

Offline J220

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #7 on: September 30, 2009, 10:56:38 PM »
It is double blinded and all participants (even placebo branch) will go off meds.  The study monitors VL & CD4, etc. very closely and if VL hits a certain level, or CD4 drops below a certain level, then you go back on meds.  The study is being very closely watched by international monitors because of the potential bad consequences of going off meds.  Every thing they do to me, a witness has to be in the room signing off on it.  Also, getting into the study is not easy as you have to have all your blood paperwork over the years, and they even verified it with my primary doctor.  There were lots of other restrictions too, such as age, VL, CD4, time on HAART, and more.  I keep this forum posted over the next few years on this study.

Rob

Thanks for sharing your experience with this trial, and thanks on behalf of all of us (if I may presume to speak for all) for participating in it. It is thanks to individuals like yourself that are willing to participate in trials that progress has, is, and will be made towards therapeutic approaches.
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline veritas

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #8 on: October 23, 2009, 09:19:07 AM »

Up-date --------- from Paris:

http://www.pr-inside.com/researchers-find-that-vacc-4x-therapeutic-peptide--r1538493.htm

I hope this good news continues for this vaccine. If this continues to be effective, not-only will it allow those on ART to take a break but also help to build the immune systems of those that tested positive with low cd4 and cd4%. The results of this study showed a 9% increase for those with a baseline cd4 count of >500 but a 25% increase for those with a baseline cd4 count <500. This is also wonderful news for those who are not responding well to ART.
All of the above in phase 2. 

v

Offline RobGage

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Status of my being in this study
« Reply #9 on: October 23, 2009, 11:47:06 AM »
Hi all,

I am going off all ART meds 4 days from today.  I stopped Atripla 10 days ago and switched to Kaletra/Combovir.  That was to avoid becoming resistant to Atripla as the concentration of those components diminishes in my blood.  Getting of Atripla has had the delightful result of my loosing some of the extreme dream episodes and by gastric system is a lot more normal.  The Kaletra/Combovir switch was a piece of cake: no side effects what-so-ever.

Now the good news: since being on vaccinated 6 times in the last 6 months, my CD4 has gone from 535 to 834.  Previously it had been slowly ramping up from a low of 235 to the 535 over a 4 year period, so this 300 count increase is really quite a pronounced upward spike.

If you wish to follow my results, I'll be posting that about every 4 weeks, as that is the frequency I get tested.

Rob

Offline Inchlingblue

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Re: Status of my being in this study
« Reply #10 on: October 23, 2009, 12:06:47 PM »

If you wish to follow my results, I'll be posting that about every 4 weeks, as that is the frequency I get tested.

Rob

Sounds great. I look forward to following your results, will you be posting here on this thread?

Offline bmancanfly

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #11 on: October 23, 2009, 01:48:16 PM »
Good luck Rob.  And thanks for sharing your experience.
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline Trout

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #12 on: December 09, 2009, 07:44:48 AM »
Hi Rob(Gage),

Have you received any test result yet that you would like to share?


Cheers,

Trout

Offline xman

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #13 on: December 09, 2009, 04:40:39 PM »
Any updates?
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 RobGage

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #14 on: December 10, 2009, 05:32:11 PM »
Hello all,

As you know, I had stopped all HIV meds the end of October.  Everything felt fine until 27 November, when I assumed I either had the flu, or another episode of "seroconversion flu", which is to say: fatigue, chills, sweats, weight loss, slight fever, but with no cough, congestion, etc.  Within the last 3 days, I feel almost normal again.

And I received, yesterday, my blood results from the 2 December draw, and it would be depressing but that I fully was aware that failure was more likely than not.  The draw showed 258 CD4, but two non-study blood draws, two days later, indicated 397 and 358.  So per the study protocol, since I am below 350,I have to get another test within the next few days and if I am still below 350, I am to resume my medications as before.  I would mention my CD4s had been ranging from 650 to 800 in the months prior to stopping meds.

It seems odd that UCLA would come up with 258 and UCSF would come up with 397 and 358 separated by just a few days.  Maybe I had a real flu and that pushed the immune system down, or maybe the vaccine is not working in me, or maybe I had the placebo.  But I am really rather sure I was not on placebo from the obvious reactions that could be seen at the injection sites.

At any rate, I will know in about 2 weeks or a bit less, and will resume meds or not depending and will let this forum know.

Rob

Offline Inchlingblue

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #15 on: December 10, 2009, 06:54:49 PM »
Rob:

Thanks so much for the update. There are so many variables that it's difficult to know for sure so I guess only time will tell.

Thanks again for keeping us posted.

According to a recent article in aidsmeds.com, Bionor is no longer looking at this vaccine for the purpose of prolonging ART-free periods:

In fact, Bionor is no longer looking at the prospect of using Vacc-4x to keep patients off ARV therapy, but rather to boost CD4 cells in treatment-experienced HIV-positive individuals with suppressed immune systems while remaining on antiretroviral therapy.

“We are hopeful that Vacc-4x will provide meaningful benefit to people with HIV who have no alternative therapies,” says Per Bengtsson, MD, PhD, Bionor’s senior vice president for development and chief medical officer. “The Thai study has re-energized the research community to search for effective vaccines to counter HIV.”


LINK:

http://www.poz.com/articles/hiv_therapeutic_vaccine_401_17513.shtml
« Last Edit: December 10, 2009, 06:59:50 PM by Inchlingblue »

Offline RobGage

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #16 on: December 10, 2009, 11:39:32 PM »
Yes, I knew of that direction by Bionor.  And have discussed that with someone familiar with the study, who basically suggested that finding enough people to go off meds made that study very expensive and difficult to conduct.  And so while there is some significant result that a large percentage of vaccine recipients can stay off meds for far longer than would be without the vaccine, the lower hanging fruit, economically, for Bionor, is as a boost to those on ART, just as Inchingblue describes.

And so, I imagine what with my likely described failure, I'll go back on ART next week and hopefully the vaccine helps me regain high CD4 count quickly, but I will admit that is my wishful thinking.

Rob

Offline Trout

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #17 on: December 11, 2009, 07:46:48 AM »
Thanks for the update, Rob.

I am wondering whether the extra CD4 cells generated Vacc-4x are functional enough and as protective against disease progression as the CD4 gains conferred by ARV therapy alone. Let's hope it does a far better job than IL-2 in that regard.


Offline bmancanfly

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #18 on: December 11, 2009, 10:01:50 AM »
Thanks for the update, Rob.

I am wondering whether the extra CD4 cells generated Vacc-4x are functional enough and as protective against disease progression as the CD4 gains conferred by ARV therapy alone. Let's hope it does a far better job than IL-2 in that regard.



Excellent point.  Higher CD4 count does not necessarily mean a better functioning immune system.

Thanks again Rob for your participation.  Best of luck.
"The trouble with the world is that the stupid are cocksure and the intelligent are full of doubt."

 Bertrand Russell

Offline RobGage

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #19 on: January 10, 2010, 01:56:35 PM »
At this time I am still "in" the study, but as you know, resumed meds.  Within two weeks the CD4 count went from 346 (as I recall) to 497 (as I recall).  VL dropped from 666,000 to 6000 same period.  Within a few days of resuming ART, I felt very much better.  A buddy who is in the same study had none of the side effects I experienced, and I am leaning toward the idea I had the swine flu, as the symptoms match, but I will never know for sure.  Another blood draw the 14th January will provide new counts and I will provide those.

Thanks,  Rob

Offline Inchlingblue

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #20 on: March 15, 2010, 12:16:52 PM »
Bionor has another vaccine, Vacc-C5, being prepared for a Phase I/II clinical trial.

Based on encouraging results from pre-clinical research, Nutri Pharma ASA's wholly owned subsidiary Bionor Immuno AS, has today announced that it will take the therapeutic and potentially preventative HIV-vaccine candidate Vacc-C5 towards phase I/II clinical trial.

Research results to date indicate that Vacc-C5 may induce a protective antibody response in  HIV patients similar to that found in patients with a very slow or non-progressing disease. This naturally very slow or non-progressing HIV infection observed in a small minority of patients has been the subject of academic interest for years and our discovery of these antibodies in such patients could lead to a significant shift in the approach to treating HIV. The results have been presented to the company's Clinical Advisory Board with very encouraging feedback, says Birger Sørensen, CEO of Bionor Immuno.

Vacc-C5

The main trigger behind the disease progression from HIV to AIDS is the hyper-activation of the immune system. This hyper-activation overwhelms and gradually causes a collapse in the immune system, leading to the AIDS stage of the disease.

From research on blood donated by patients with a very slow or non-progressing HIV disease, the company has succeeded in identifying a specific part of the virus, C5, which is believed to induce hyper-activation of the immune system. Antibodies to this specific part are likely to be protective and cause a slow disease progression. Using its unique technology, the company has developed the vaccine candidate Vacc-C5, that is designed to induce a similar antibody response to the one discovered in patients with naturally very slow disease progression. Vacc-C5 has passed pre-clinical research tests showing that it has the potential to induce the desired antibodies.

The antibodies induced by Vacc-C5 are expected to be beneficial at all stages of HIV disease and produce a dual effect; i) slowing down or halting the disease progression and ii) significantly reducing the production of virus. It is believed that the combination of Vacc-C5  together with Vacc-4x, the company's most advanced vaccine candidate (currently in phase II placebo controlled international multicenter trial with 135 patients enrolled; results expected in October 2010), could form a potent preventative HIV vaccine.


Continued . . .

LINK:

http://www.pr-inside.com/vacc-c5-to-be-prepared-for-phase-i-ii-clinical-tri-r1774764.htm

Offline ecarina

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Re: Clinical Trial of Vaccine (Vacc-4x) That Could Prolong ART-Free Periods
« Reply #21 on: April 20, 2010, 05:11:51 AM »
Hi Rob,

Could you please update your latest result. I hope everything is going well for you.

Ecarina

Offline RobGage

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Hello forum.  It has been a long time since I made an update, but I will report that I am back in another VACC-4X trial, since this first one appears to "work" to some degree, meaning that it might reduce the VL setpoint when not on antivirals and therefor something in it must be helping the body combat the virus.

So I have been re-vaccinated with the same peptide mix and the study is nearly a repeat of the last one.  The hoep is that repeated rounds of vaccine, and periods of meds may teach the body how to deal with it.

That's it!

Rob

Offline Dr.Strangelove

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Thanks for the update! Please keep up posted

 


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