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Medicine Science

HIV Vaccine Safe Enough To Pass Phase 1 Human Trials 141

Posted by Soulskill
from the good-work-folks dept.
An anonymous reader sends this excerpt from Western University in Canada: "The first human applied clinical study (SAV CT 01) using a genetically modified killed whole-virus vaccine (SAV001-H) to evaluate its safety and tolerability was initiated in March 2012. This study is a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. Infected men and women, 18-50 years of age, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo. Sumagen announced today the patient enrollment has progressed smoothly and there have been no adverse effects observed including local reactions, signs/symptoms and laboratory toxicities after SAV001-H injection in all enrolled patients to date. With these interim results, the SAV001-H has proven safety and tolerability in humans and given Sumagen confidence for the next clinical trials to prove its immunogenicity and efficacy evaluation."
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HIV Vaccine Safe Enough To Pass Phase 1 Human Trials

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  • by alen (225700) on Tuesday November 06, 2012 @09:07PM (#41902157)

    Along with the anti-vaccine nutters?

    Clearly using real HIV viruses must be very risky and dangerous

    • by ClintJCL (264898)
      With your ability for nuance, the debate is bound to go far!
    • Re: (Score:3, Funny)

      by aliquis (678370)

      It all depends on how much you dilute it.

    • by Lord Kano (13027)

      Along with the anti-vaccine nutters?

      Clearly using real HIV viruses must be very risky and dangerous

      You go first. If you're still healthy in 20 years, maybe I'll try it.

      LK

    • Actually, if they are looking for volunteers, I'm more than willing. It wouldn't be the first time working around life-threatening biologicals. I was part of a team researching MRSA back in the '90's and the experimental vaccine we all had to have to work around it was no joke for side-effects (necrotizing fasciitis).
  • by starworks5 (139327) on Tuesday November 06, 2012 @09:07PM (#41902163) Homepage

    That I can tell women that I have the AIDS vaccine at the bar, and can give it to them through intra-muscular administration.

    • by Anonymous Coward

      It still means Africa is going to be the last place to get the vaccine

      • Re:Does that mean (Score:5, Interesting)

        by Anonymous Coward on Tuesday November 06, 2012 @09:28PM (#41902329)

        That's not the problem. Believe it or not, the problem is getting them to use it. My father has worked in Africa for more than 20 years now and there is a massive amount of distrust for this sort of thing among the native populations. Many average people even think this type of thing is a CIA plot to kill them off. With the things people have done to them over the centuries, I'm not terribly surprised, but there has been a lot of effort over the last few generations to fix that, and yet it still remains. It won't be easy to overcome.

        • We bring them crap such as war, drugs, weapons and Christianity, and they embrace it. We instead bring them the cure for HIV, and they reject it. WTF.

          • Strictly speaking, they already had war, drugs, weapons, and Christianity......
            • strictly speaking, their wars had simpler motivations, their drugs where natural and for ceremonial use, their weapons far less advanced, and they certainly didn't have something as retarded as christianity.

              • War and its motivations are as old as the hills, drugs were used just like MJ is for 'medicinal' purposes, their weapons were certainly less advanced, and their religion involved human sacrifices (and Christianity has been in Africa longer than it's been in Europe).
          • by tbird81 (946205)

            Yep. But we keep spending money on this waste of space.

            We have to stop spending money on all the world's problems.

            • Re: (Score:2, Interesting)

              by Anonymous Coward

              Spending money would be one thing. We're spending debt, money we don't have.
              It's the same as charging to your credit card a thanksgiving meal to a homeless person, so that you can go home and eat a can of beans.

              I'm all for charity, but you have to take care of yourself first (take care of, not live in luxury.) The country needs to get out of debt before we continue all this foreign aid.

            • Your sarcasm detector seems to be broken.

              Anyway, nobody asked anything from the US. Actually, you've caused most of this century's international conflicts, so please stay home.

        • Re: (Score:3, Informative)

          by grinchier (1373305)
          I have lived in Africa my whole life and that CIA plot thing is old. It's now a "plot by multi-national pharmaceutical companies". At least, it was during Thabo Mbeki's tenure as South African president (http://en.wikipedia.org/wiki/AIDS_denialism#In_South_Africa). AIDS awareness is alive and well here.
    • You mean, like this: http://smbc-comics.com/index.php?db=comics&id=1921#comic [smbc-comics.com]?

  • So... (Score:2, Interesting)

    by Anonymous Coward
    The test for HIV tests for antibodies... So the human body already makes antibodies against HIV... So how are the antibodies for this vaccine different? *These* work? How?
    • Re:So... (Score:5, Insightful)

      by Sir_Sri (199544) on Tuesday November 06, 2012 @09:30PM (#41902339)

      A very small percentage of the population makes them. One option for a vaccine is to try and hack that immunity into the rest of us.

      • Re:So... (Score:5, Insightful)

        by slew (2918) on Tuesday November 06, 2012 @10:04PM (#41902545)

        As I understand it, humans will always produce antibodies to fight infections like HIV. Unfortunatly, the antibodies that humans normally produce in the attempt to neutralize and HIV infection don't appear to be very good at it. [caltech.edu] The short story is that somehow HIV evolved to avoid having many fewer binding locations so the most effective "Y" shaped antibodies cannot effectively attach bivalently (in two places). This bivalent attach is apparently the most common strategies used by our immune system.

        Apparently some people can make more potent antibodies called bNAbs, but often HIV mutates to avoid these as well, but sometimes there are successes.

        I'm unclear on why this new Canadian/Korean HIV vaccine would be any better at bootstrapping the immune system than the most recent failed attempts. The only novel part that I can tell about this, is that they are using "whole" (but genetically modified) HIV instead of putting HIV protein genes codings into more common viruses, but if HIV is as crafty as it seems to be, this may only be a simple shot-in-the-dark hope that somehow bootstrapping the immune system will allow the body to come up with a way to fight off HIV before it gets a chance to overwhelm the immune system. Color me skeptical as that was what the other vaccines attempted to do, but it's not clear that this will be a successful route.

        • Re:So... (Score:5, Funny)

          by GNUALMAFUERTE (697061) <almafuerte@nOsPAM.gmail.com> on Tuesday November 06, 2012 @11:01PM (#41902823)

          Well, look at it this way:

          Worst case scenario, nothing happens. Good-case scenario, it cures aids. Best-case scenario, HIV mutates into something radically worst and gives us the zombie apocalypse we've been waiting for.

        • I think it's a bit simpler than that. Antibodies are very specific to a protein, and must be, you don't want your antibodies recognizing a protein you make yourself. Retroviruses mutate extremely fast as a result of going backwards, from RNA to DNA. I forget the numbers, but a professor in a molecular biology class I was in calculated it on the board. Given the rate of mutation, the number of viruses in an infected patient, and how fast the immune system responds, the odds of the immune system destroyin
          • by Sir_Sri (199544)

            I was referring to the very small percentage of people who are immune to HIV, and trying to figure out what causes that, and how to get it into the rest of us.

    • A very interesting question.
      Especially (from the /. summary) that this vaccin is claimed to cure HIV.
      Vaccins usually empore your imune system to protect against starting infections. However they don't cure an infection that already has broken out.

  • Why is a vaccine useful to (and being tested on) someone already infected?
    • by Anonymous Coward

      Vaccines can still be effective on people recently exposed.

    • Re: (Score:2, Insightful)

      by Anonymous Coward

      Because if the vaccine is still active in any way, it can't infect anyone further.

    • by alen (225700)

      We should go ask magic Johnson

    • by Carnildo (712617) on Tuesday November 06, 2012 @09:20PM (#41902265) Homepage Journal

      Phase 1 trials are the "prove the vaccine doesn't give you AIDS" (or cause other medical problems) stage of things.

    • by Anonymous Coward

      guessing:
      Because HIV is the virus, not the disease. If you develop an immune response to the virus before it causes AIDS, then that's the prevention.

      • by Yaotzin (827566)

        Vaccinating for HIV usually has no real effect since it only immunizes the host to one HIV antigen when there a multitudes due to highly recombinant genes. The only way this vaccine could work is if it immunizes the host to all possible antigens of HIV or somehow allows the adaptive immune system to recognize some kind of shared antigen that is otherwise not recognized as being pathogenic.

        Usually vaccinating for an infection already in place is pointless since the adaptive immune system will either already

    • by Anonymous Coward

      In the highly unlikely case that it goes Horribly Wrong, it won't give them HIV again.

    • It's not. (Score:4, Informative)

      by mosb1000 (710161) <mosb1000@mac.com> on Tuesday November 06, 2012 @09:49PM (#41902459)

      They're testing whether or not it's safe, not whether it will be effective.

    • by dywolf (2673597)

      Think about it. They are giving someone the full blown HIV virus. Modified, but still the HIV virus. You know how people sometimes get sick with teh flu after being given flu shots? Same deal.

      Do you really want to be responsible for giving someone, who was healthy before, HIV from your experimental vaccine?
      So you test its initial or macro scale safety on people who already have HIV.

  • Has anyone found any details on the genetic modification. Because ... HIV is not alive, a virus is only a blueprint for itself, which the cell starts to copy. And this copying process than leads to side effects depending on what the virus information contains - the symptoms. So a "whole virus" that is "killed" is plain nonsense. And as there are only extremely rare cases where there are therapeutically relevant anti-HIV antibodies ever (usually the restriction is T cell based or CCR5 mutations) ... a vaccin
    • by wincel (2761161)
      I suppose it is that. That is just the envelope protein delivered by another virus (Vesicular Stomatitis Virus). http://www.ncbi.nlm.nih.gov/pubmed/19264597 [nih.gov] These mutate like crazy, so expressing a single one is not going to help much ever to generate a therapeutically active immune response. Having tons of antibody that don't work against the developing HIV mutant is of no use.
      • by wincel (2761161)
        No surprise, the impact factor of the journal this system was published in is very low, just 3.36 . Good journals have at least 5-10, the top ones an impact factor of 20 and higher ... http://vir.sgmjournals.org/ [sgmjournals.org]
    • Re: (Score:2, Informative)

      by Anonymous Coward

      "Killed virus" means the virus is damaged to the point that they cannot be replicated, but the immune system can still recognize and remember it.

    • A virus is made up of a protein shell containing RNA or DNA. This virus is enveloped in cell membrane and contains RNA transcriptase to generate DNA from RNA (meaning retrovirus). The virus latches to a beta T4 cell and injects RNA+transcriptase, which transcripts DNA and then inserts it into the DNA, which produces RNA to build new viruses. These viruses are packaged in a protein shell and then budded--they push against the cell wall until a lipoprotein envelope wraps around them (cell wall material), t

  • There are *lots* of HIV vaccines in development, many reaching phase I and others going further. There's even one recent phase III showing some evidence of a preventative effect.

    For a review check: http://www.ncbi.nlm.nih.gov/pubmed/22710904 [nih.gov]

  • I'm going to cheer for these folks.

    It's been almost 20 years since i lost friends. :-(

  • From Sumagen's website:

    "Sumagen’s HIV/AIDS vaccine is also supported for its R&D cost from the HIV/AIDS vaccine development fund, jointly launched by the Bill and Melinda Gates Foundation and the government of Canada."

  • There is no (Canadian) Western University. It's the University of Western Ontario, sometimes called "Western" for short, but never Western University. It's also only western if you're from southern Ontario since its actually located in the south east corner of the province.

  • Search Dr Sebi on youtube, he had been curing cancer for more than a decade just by herbs.
  • I don't think they understand what a vaccine is?

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