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First Human Study of HIV Vaccine Vacc-C5 to begin

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tatosao24:
This one could be really good! I wonder how long will it take to go to market if it pass all the trials....

Link for the full article:

http://www.bionorpharma.com/en/News_archive/2012/All/First+Human+Study+of+HIV+Vaccine+Vacc-C5+to+begin.b7C_wlnQ1i.ips


First Human Study of HIV Vaccine Vacc-C5 to begin
Oslo 29.05.2012 - Animal Studies Indicate Similar Generation of Immune Responses as Those in HIV Patients who Naturally Suppress the Infection


News Summary

Open, clinical study, dose escalating, phase I/II, with Bionor Pharma`s second therapeutic HIV vaccine to begin at Oslo University Hospital.
Researchers hope Vacc-C5 will prevent hyperactivation of immune system that leads to AIDS, and possibly thereby make patients able to control HIV replication without the need for medication.
The study will investigate whether humans develop antibodies to HIV as a result of vaccination with Vacc-C5, and if these antibodies have same properties as antibodies found in “long term non progressors,” in other words patients who live with HIV but are able to naturally suppress the virus.
Bionor Pharma ASA announced today that the first study of Bionor Pharma’s Vacc-C5 is now approved to begin at Oslo University Hospital. Vacc-C5 is a therapeutic HIV vaccine developed to slow down or stop induction of immune hyperactivation, a feature that drives the production of HIV and is damaging the immune system, leading to AIDS. Vacc-C5 also may have the potential to be a preventive vaccine, alone or in combination with Vacc-4x.

The phase I/II study will use Vacc-C5 at three different dose levels, in order to evaluate safety and provide a determination for the optimal dose of the vaccine,  when given intradermally (in the skin) or intramuscularly.

“The pre-clinical studies of Vacc-C5 in rabbits, and sheep, as well as data confirming an association between high antibody levels and slow progression of HIV in humans have generated considerable interest,” said Dag Kvale, MD, PhD, Principal Investigator at Oslo University Hospital.  “We look forward to see how people living with HIV respond when on Vacc-C5.”

The study seeks to recruit 36 patients who have been infected with HIV for at least one year.  Study participants must have been stable on antiretroviral therapy (ART, traditional HIV medicine) for at least six months with a viral load of less than 50 copies per milliliter.  The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels.  Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers.  Vacc-C5 will be given in combination with two different adjuvants, (that enhance the immune response), either GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) or Alhydrogel (an aluminum-based treatment).

elf:
thanks
this is great  :)

freewillie99:
Can anyone with a scientific background comment on this?  Admittedly, I'm dubious; particularly when I read Bionor's been testing their vaccine on "rabbits and sheep". 

Maybe I just have that xenophobic "if it's not happening in the US, it's not happening" mentality working.

Thanks.

Dr.Strangelove:
Why is the study dubious just because they did some pre-clinical trials on rabbit and sheep? These are also mammals, just as mice and humans. And they don't say what kind of tests they did exactly. I am pretty sure that the development of the vaccine itself, however, took place with the use of mice.

I have a background in molecular biology, though neither immunology nor HIV are my areas of expertise.

This study looks very promising to me.
Clinical trials are expensive. They wouldn't do it if they don't believe in their vaccine. (In contrast, what I find dubious are startups, that have published one paper in a mediocre journal, claim to have the solution for the cure and are now looking for investors.)
The other vaccine Bionor is developing, Vacc-4x, has already shown to be effective in reducing viral loads (but it was only a small-scale trial). So, this gives me confidence that they are on the right track.
If they succeed, one day we could stop taking pills every day and instead get this therapeutic vaccine once or twice a year to remain UD. Also, it shouldn't have side effects like the other drugs, since it's just antibodies. 

freewillie99:

--- Quote from: Dr.Strangelove on May 31, 2012, 06:15:19 PM ---Why is the study dubious just because they did some pre-clinical trials on rabbit and sheep? These are also mammals, just as mice and humans. And they don't say what kind of tests they did exactly. I am pretty sure that the development of the vaccine itself, however, took place with the use of mice.

I have a background in molecular biology, though neither immunology nor HIV are my areas of expertise.

This study looks very promising to me.
Clinical trials are expensive. They wouldn't do it if they don't believe in their vaccine. (In contrast, what I find dubious are startups, that have published one paper in a mediocre journal, claim to have the solution for the cure and are now looking for investors.)
The other vaccine Bionor is developing, Vacc-4x, has already shown to be effective in reducing viral loads (but it was only a small-scale trial). So, this gives me confidence that they are on the right track.
If they succeed, one day we could stop taking pills every day and instead get this therapeutic vaccine once or twice a year to remain UD. Also, it shouldn't have side effects like the other drugs, since it's just antibodies.

--- End quote ---


Fantastic.  Just what I was looking for.  Thanks for the insight!

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