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First Phase of AIDS Vaccine Trials Successful 554

Posted by ScuttleMonkey
from the baby-steps dept.
rbarreira writes "Xinhua online is reporting on the success of the first trial phase of an AIDS vaccine, which was started on March 2005. From the article: '"Forty-nine healthy people who received the injection showed no severe adverse reactions after 180 days, proving the vaccine was safe," said Zhang Wei, head of the pharmaceutical registration department of the SFDA. "The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," he told the press conference.' After the results are further analyzed, 800 more voluntaries may be needed for the second and third phases of the vaccine's trial."
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First Phase of AIDS Vaccine Trials Successful

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  • by lecithin (745575) on Sunday August 20, 2006 @03:58PM (#15945012)
    "Forty-nine healthy people who received the injection showed no severe adverse reactions after 180 days, proving the vaccine was safe,"

    Okay, success is good, but...

    This is not proof. It isn't even close to it.

    How long was Fen Phen tested? Thimerosal? RotaShield? Whoops.

    I hope that this does work but stating that the vaccine has been prooven safe is very misleading.
    • Re: (Score:3, Interesting)

      by SengirV (203400)
      Birth defects anyone? Some proof there alright.
      • Re: (Score:3, Insightful)

        by WilliamSChips (793741)
        I think that even with birth defects a cure for AIDS would be useful.
        • Re: (Score:3, Funny)

          by debilo (612116)
          I think that even with birth defects a cure for AIDS would be useful.

          Plus, for all we know, most males lack a uterus.
        • by AusIV (950840) on Sunday August 20, 2006 @05:01PM (#15945240)
          I think that even with birth defects a cure for AIDS would be useful.

          There's a difference between a vaccine and a cure. If you could cure someone of AIDS and give their immediate descendants of some minor birth defects, that might be worthwhile. But a vaccination is something that would be given to everyone in order to prevent them from getting HIV in the first place. This being the case, birth defects are definitely not an acceptable consequence.

          • by Turakamu (523427) on Sunday August 20, 2006 @05:31PM (#15945328)
            This being the case, birth defects are definitely not an acceptable consequence.

            Tell that to the gay community.
            • by daeg (828071) on Sunday August 20, 2006 @06:26PM (#15945545)
              Or the elderly community. 27% of those in the US living with HIV are over 50 and they are the fastest growing group of new HIV cases [ http://www.cbsnews.com/stories/2006/08/18/eveningn ews/main1913646.shtml [cbsnews.com] ]
            • by Anonymous Coward on Sunday August 20, 2006 @06:29PM (#15945553)
              > Tell that to the gay community.

              Thank you! Finally, someone who gets it.

              I'm a lesbian. I also have an immune system/skin condition called psoriasis. I've spent the last eight years fighting with different doctors for the chance to try new treatments when they become available.

              "This drug causes birth defects so women of child-bearing age..."
              "I'm a lesbian."
              "Yes, but while you are of child-bearing age I'm not comfortable prescribing..."
              "Lesbian. Leeeeeeeeesbian."
              "Yes, I understand, but while there is a possibility of your becoming pregnant..."

              Certain rules do not apply to certain groups. I wish more medical doctors had the reasoning capacity that you have.

              • by gnarlin (696263) on Sunday August 20, 2006 @06:52PM (#15945628) Homepage Journal
                I'm a lesbian. I also have an immune system/skin condition called psoriasis. I've spent the last eight years fighting with different doctors for the chance to try new treatments when they become available.
                Perhaps I could offer you some advice.
                The reason for the doctors hesitation to prescribe you the experimental medicin is due to their danger of being liable for the side effects of those drugs that have not been officially aproved by the FDA, even if you acknowledge the danger of said effects.


                Go talk to a lawyer and have him/her/it draft a letter of legal absolution from liability which you can offer the reluctant doctors in exchange for their cooperation.
                Basically, they are just covering their own asses when they are denying you those drugs. Good luck.

                Also, I think that the slashdotting community would probably not be adverse to you writing down some of your romantic exploits. In fact that's probably what the slashdot's journal was made for: Hot lesbian love ;-)

              • Just because you can't get pregnant through your normal sexual conduct doesn't mean you can't ever do so. There are Lesbian's who opt for fertilization through donated sperm, etc etc. In your case, however, my guess is that you have no such plans. Still, people do change their minds, so I guess that as recommended by others a letter of absolution or something along those lines might reduce your docs worries enough for him to prescribe the treatment. That, or finding a doctor who gets your situation a little
    • Re: (Score:3, Funny)

      by jeremymiles (725644) *
      Yeah, safe as in "Forty nine healthy people who went up in a space shuttle came back home fine, which proves it's safe".
    • by Kitten Killer (766858) on Sunday August 20, 2006 @04:21PM (#15945106)
      That's why this is a Phase I trial.

      Drug trials go through three phases, the first of which consists of a very small number of subjects. It's essentially the first time the drug is used on humans and to see it doesn't have immediate, obvious side effects not observed in animal trials. The 2nd and 3rd phases continue to monitor safety while attempting to determine the efficacy of the drug.

      Keep in mind, that a lot of the recalled drugs, such as the COX2 inhibitors like Vioxx, don't show negative side effects until your trial goes into hundreds or thousands of subjects. And even then, the drugs are continually monitored after their release to look for effects that might be present only in 0.1% even or 0.001% of the population
      • by Jahz (831343) on Sunday August 20, 2006 @04:58PM (#15945233) Homepage Journal
        Anybody who has taken a statistics course should have laughed at the (wording of the) claim in this post. A 49 person sample isnt supposed to prove that a drug is safe. It's meant to prove that it didnt kill or severly damage 49 people. Think about if one of these people had died as a direct result of taking this vaccine. It would be stopped the research right there with *minimal* loss of life. Now if the first test was on 800 people (like the second test will be), it might have killed 16 people. The sample size will continue to increase methodically in conjunction with the researchers statictical confidence level.


        This is also why some drugs get through the testing hurdles and still manage to kill/harm thousands of people. Even when the statistical formulae work out, there is still the chance that the result was due, in part, to randomness in the population. Consider that 100 is 99.99% of 1,000,000...

    • by CharonX (522492) on Sunday August 20, 2006 @04:47PM (#15945191) Journal
      First of all, this is only Phase 1 of 3.
      Phase 1 in clinical trials is meant to make sure the drug in general is "safe" and to determine the maximum safe dosage.
      Testing if the drug really works as expected, how effective it is etc. is done in Phases 2 and 3 with a much larger group, in double-blind experiments.
      Still, before Phase 1 there were many other experiments - i.e. test with animals, computer simulations etc. - which must have shown some promise otherwise they wouldn't spend money on the human trials.
  • 2000 yuan AIDS you!
  • by Anonymous Coward on Sunday August 20, 2006 @04:01PM (#15945022)
    If this goes well we won't have to close the pools.
  • HIV (Score:5, Insightful)

    by mfh (56) on Sunday August 20, 2006 @04:02PM (#15945028) Homepage Journal
    Does it work though? Have these people been exposed properly to HIV and did they really reist picking it up?

    All it takes is one night in the wrong club at the wrong time and no matter what kind of protection you have -- it could be too late.
    • Re: (Score:3, Informative)

      Didn't you read the article? The HIV-1 cells they injected were genetically engineered not to have the ill effects of HIV/AIDS. So they were meant to, in all actuality, be like the HIV/AIDS of deadly reputation, but without the threat of lawsuits waiting in the wings.
       
      Any questions?
    • well, if you are really looking for some fun in the wrong club at the wrong time you're not really concerned about protection! you'll probably just play with the odds that nothing wrong is going to happen...
    • Re:HIV (Score:5, Informative)

      by venicebeach (702856) on Sunday August 20, 2006 @04:25PM (#15945121) Homepage Journal
      from TFA:
      Some recipients' cells and body fluids in the combined group appeared immune to the HIV-1 virus, said Sang Guowei.
      Not sure exactly what this means, but it seems like they extracted body fluids and tried to infect with HIV in-vitro.
  • by slapyslapslap (995769) on Sunday August 20, 2006 @04:02PM (#15945029)
    "The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," Doesn't it take a little longer to know if HIV is going to take hold? "Immune" is a little presumptive at this point.
    • by albalbo (33890) on Sunday August 20, 2006 @04:18PM (#15945095) Homepage
      Well, I seriously doubt that they were telling these people to go out, sleep around and try to get pozzed up - that would be mildly unethical, I would think.

      I would suggest they probably tried introducing HIV into a blood sample of the patient, and tried to see how successful HIV was in reproducing. If it can reproduce well in "normal" blood, but badly in the blood of the patient, that's a reasonable indication that they're immune.
  • Proof of Immunity? (Score:3, Interesting)

    by infidel13 (978594) on Sunday August 20, 2006 @04:04PM (#15945035)
    According to the article, "The recipients appeared immune to the HIV-1 virus 15 days after the injection." Maybe someone can help with this, but how do you test immunity with fatal illnesses? Obviously you can't simply expose the subjects to the pathogen causing the disesase (not ethically, anyway). Does anyone in a medical field happen to know how this works?
    • You know that statistically, X percent of a population will contract the disease over a specific period of time, so you vaccinate a bunch of people, and you check whether the number of people getting the disease in your group is lower than the average or not.
      • by jeremymiles (725644) * on Sunday August 20, 2006 @04:11PM (#15945060) Homepage Journal
        This is the first trial, which means it's a phase 1 trial [wikipedia.org]. Phase 1 trials are not designed to demonstrate efficacy, they are to demonstrate safety. Whether it works or not comes next.
    • by zoftie (195518)
      it's china, they can have people for the [communist] cause by the thousands.
      • Re: (Score:3, Insightful)

        by 1u3hr (530656)
        it's china, they can have people for the [communist] cause by the thousands.

        You won't find any Communists in China under 75 these days. Mao died 30 years ago and Communism shortly after.

    • by EvilIdler (21087)
      I'm not a doctor, but I'm guessing they simply extract some blood and infect that
      in a laboratory.
    • by QRDeNameland (873957) on Sunday August 20, 2006 @04:57PM (#15945232)

      "I dunno how much AIDS scare y'all, but I got a theory - the day they come out with a cure for AIDS. Guaranteed, one-shot cure. On that day, there's gonna be fucking in the streets, man. It's over! Who're you? C'mere! What's your name, baby? No, it's over, yeah, woo-hoo! Man, if you can't get laid on that day, cut it off."

      -- Bill Hicks

      • by McGiraf (196030) on Sunday August 20, 2006 @05:09PM (#15945266) Homepage
        That will be a great day for herpes, siphylis, crabs, pregnancies, clamedia ....
        • by MarkRose (820682) on Sunday August 20, 2006 @05:31PM (#15945327) Homepage
          That will be a great day for herpes, siphylis, crabs, pregnancies, clamedia ....

          I felt a disturbance in the force. It is as if the fantasies of millions of slashdotters were suddenly silenced.
        • Re: (Score:3, Interesting)

          by RsG (809189)

          siphylis, clamedia

          Both of which are already curable with antibiotics.

          crabs, pregnancies

          Both are just minor passengers. The former goes away with treatment, the latter after 9 months or less. Reminds me of an old joke: "Life, an STD that's 100% fatal in all who contract it".

          herpes

          This is the one I'd worry about. It's still incurable and more contagious than any of the others in your list.

          However, stop and think about this for a second. If we can cure HIV/AIDS, then we've found a way to expunge the body

          • Re: (Score:3, Interesting)

            by beheaderaswp (549877) *
            Regarding herpes, the negativity of this is more socially imposed rather than from a health standpoint or true medical concern.

            The fact of the matter is that a majority of us have herpes of some type (cold sores)- except that infection is not on our genitals.

            Personally, I fail to see the alarming hysteria regarding herpes as anything other than social stigma. Social stigmas can be pretty strong, but not life threatening. So my guess is that the herpes stigma these days, is about as powerful as the inter-rac
  • Booster shots? (Score:3, Interesting)

    by tacarat (696339) on Sunday August 20, 2006 @04:16PM (#15945082) Journal
    I'm curious if this vaccine is being set up for one-time immunizations with possible booster shots, or if it'll be a more frequent thing like the flu shots. One of the vexing traits of HIV is it's rapid mutation rate. The flu and cold viruses are pretty much the same.

    "Spring break is coming up! Get your annual HIV immunizations here!"

    The only real downside is that if this (or another) vaccine is effective and reliable, then there's the risk of other STDs becoming more prevelant again as people relax their safe sex practices. That includes unplanned pregnancies. Some people really do need a hypothetical gun to their heads to think about using condoms or monogamy.
    • Re: (Score:2, Interesting)

      by Short Circuit (52384) *
      The only real downside is that if this (or another) vaccine is effective and reliable, then there's the risk of other STDs becoming more prevelant again as people relax their safe sex practices. That includes unplanned pregnancies. Some people really do need a hypothetical gun to their heads to think about using condoms or monogamy.

      Hate to burst your bubble, but most people I know don't use condoms to avoid disease, they use them to avoid pregnancy. Condoms only reduce the transmission of a subset of STDs.
  • by Mutatis Mutandis (921530) on Sunday August 20, 2006 @04:23PM (#15945110)

    The actual press release is more cautious than the excerpt that is quoted here; describing the result of the trials as saying that the vaccine is "safe and possibly effective." Apparently there were no ill effects, and if I interpret the text correctly, they detected antibodies against whatever these people were injected with. Which does not prove at all that the vaccine could be effective, because the envelope proteins of HIV are so variable that buidling up immunity is enormously difficult. However, it is probably as much as one could reasonably hope for in this first phase of trials.

    That said, there is nothing in this press release to suggest that this vaccine trial will have a better outcome than the series of failed trials that have already preceded it. Mainly because there is very little information in this press release at all. Obviously, it was written by someone who did not have a clue about the science behind the trials; you can't tell from this what the vaccine consists of and how it is supposed to work. More worryingly, the "director of the National Institute for the Control of Pharmaceutical and Biological Products" is quoted as saying that "The HIV-1 specific cells injected into the recipients were the DNA fragments of the virus which don't cause infection." Which is nonsensical enough to suggest that the aforementioned director, who held the press conference, doesn't have a clue either. Probably he is more remarkable for his political skills than his medical ability.

    But maybe these Chinese researchers are on the right track -- who knows? A vaccine against HIV is very much needed, and the hope that we will be able to create one seems to shrink with every new failure.

    • Re: (Score:3, Interesting)

      by benicillin (990784)
      To clarify what this very eloquent yet seemingly retarded contributor previously wrote: The director clearly knows what he is talking about. Test subjects were injected with parts of the virus that don't cause infection so as to NOT INFECT THEM!!! with the virus. Instead, they were given non-infectuous parts of it so that the body would be able to recognize the virus if it were to come into contact with the system later. This is the whole point of vaccines.

      I am willing to bet these patients would be somewh
  • HIV test (Score:5, Insightful)

    by Kitten Killer (766858) on Sunday August 20, 2006 @04:33PM (#15945151)
    I didn't see a journal article that corresponds to this clinical trial but I'd be interested to know if the use of this vaccine precludes later HIV testing.

    For the non-biologists: vaccines are often based on exposing the body to a protein from the virus (but not the entire virus). In doing so, the body produces antibodies that recognize the protein. The next time the body sees the protein (i.e. when exposed to the actual virus), the body will be able to quickly destroy the virus particles before the person becomes infected.

    However, a lot of tests for viral infection is based on the presence of the antibodies in blood. So, if the person has been immunized using the vaccine, the person will have those antibodies in blood, and it becomes difficult to tell whether the antibodies came as a result of vaccination or infection.
    • Re:HIV test (Score:5, Informative)

      by Snootch (453246) on Sunday August 20, 2006 @05:14PM (#15945277)
      However, a lot of tests for viral infection is based on the presence of the antibodies in blood. So, if the person has been immunized using the vaccine, the person will have those antibodies in blood, and it becomes difficult to tell whether the antibodies came as a result of vaccination or infection.

      There are quite a few different tests for HIV - you're right, the primary test is antibody-related (a quick-n-dirty relative of the Western blot, followed up by an actual high-precision blot if the initial screening turns up positive), but there are alternatives based on testing for the actual genes.

      In a nutshell, the sample is combined with a set of enzymes and primers that will replicate only a specific stretch of DNA (in this case, the HIV genome). If there is HIV in the blood, you'll end up with a lot of HIV DNA around the place, which you can then test for with fluorescent probes or something similar.

      This type of method would not be affected by anything your immune system does, as it tests directly for the presence of the virus.

      There's a list of the available tests, and a bunch of other information - mostly aimed at patients - here [hivtest.org].
  • by clragon (923326) on Sunday August 20, 2006 @04:36PM (#15945156)
    "The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," he told the press conference.
    ...
    "The HIV-1 specific cells injected into the recipients were the DNA fragments of the virus which don't cause infection," [Sang Guowei] told Xinhua.

    Biology is not my forte, but since the HIV-1 virus was made to NOT cause an infection, how would they know if the vaccine actually worked?
  • Are we going to see this kind of vaccine deployed where it's mostly needed, in the poor african countries that cannot afford to pay by the nose for it? I don't think so... and if some of those 3rd world countries who happen to have the technology to fabricate it when it's done dare to do so (as Brazil has been doing for a long time with many anti HIV drugs) the pharmaceutical industry will go mental. You know... first the money, our patents, then, if it's reeeeally necessary the well-being of others.
  • AYDS (Score:3, Funny)

    by porkmusket (954006) on Sunday August 20, 2006 @05:17PM (#15945289) Homepage
    I was overweight and embarrassed to go anyplace. AYDS [google.com] helped me get back into a size 12.

    Mod me off-topic, I don't care. That video is funny shit.
  • by adam.conf (893668) on Sunday August 20, 2006 @05:49PM (#15945408)
    I cannot be the only one to have noticed that the results of this trial do NOT indicate that the vaccine is effective in protecting against the HIV virus. The trial patients were not ever injected with live HIV viruses.

    All that has been demonstrated is that the vaccine doesn't have an immediate lethality in a small group of (presumably) ethnically similary people. They placed HIV virsues in blood samples obtained from these people, and the blood mounted an immune response. I'd like to point out that even people dieing of AIDS demonstrate an immune response to the HIV virus -- this is the very nature of the ELISA test used to diagnose the disease! Further, a demonstrated "immunity" in a small sample of blood is nothing; the body demonstrated immunity to the disease, often for the better part of a decade, before dying of it during the normal course of HIV/AIDS.

    So, while any development towards a vaccine for the HIV virus is unquestionably a good things, lets not read too far into this.
  • by Robotech_Master (14247) on Sunday August 20, 2006 @06:52PM (#15945627) Homepage Journal
    Imagine being willing to be shot up with a dead form of the AIDS virus. Which, for all you know, might well end up giving you AIDS.

    For the equivalent of $250.

    Damn.
  • by krunk4ever (856261) on Sunday August 20, 2006 @06:52PM (#15945631) Homepage
    So after reading the summary, I was wondering what types of healthy idiots were willing to test out a new vaccine by injecting themselves with the HIV virus. Who knows, if it doesn't work, do you get stuck with HIV the rest of your life.

    However, upon reading the article, it states:
    "The HIV-1 specific cells injected into the recipients were the DNA fragments of the virus which don't cause infection," he told Xinhua.

    and that makes a lot more sense now.
  • by slashdotmsiriv (922939) on Sunday August 20, 2006 @07:03PM (#15945659)
    "This is useless" would say-the Health Minister for South Africa, Manto Tshabalala-Msimang.

    She has her own "very effective" approach against AIDS/HIV. She sais it is vital for people to build up their immune system so she strongly
    believes in giving people the choice between antiretroviral drugs and taking traditional remedies, such as lemons,
    garlic and beetroots. In fact she promotes mostly the second while her boss, never acknowledged that HIV is the cause of AIDS.

    http://www.medicalnewstoday.com/healthnews.php?new sid=50037 [medicalnewstoday.com]
  • by Aqua OS X (458522) on Sunday August 20, 2006 @10:31PM (#15946224)
    Well, it's that time of the year again. We haven't had an AIDS cure post in a few months.

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