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First Phase of AIDS Vaccine Trials Successful

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."

49 of 554 comments (clear)

  1. 49 people + 180 days = proof?? by lecithin · · Score: 4, Interesting

    "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.

    --
    It could be worse, it could be Monday.
    1. Re:49 people + 180 days = proof?? by jeremymiles · · Score: 3, Funny

      Yeah, safe as in "Forty nine healthy people who went up in a space shuttle came back home fine, which proves it's safe".

      --
      GENERATION 26: The first time you see this, copy it into your sig on any forum and add 1 to the generation.
    2. Re:49 people + 180 days = proof?? by WilliamSChips · · Score: 3, Insightful

      I think that even with birth defects a cure for AIDS would be useful.

      --
      Please, for the good of Humanity, vote Obama.
    3. Re:49 people + 180 days = proof?? by debilo · · Score: 3, Funny

      I think that even with birth defects a cure for AIDS would be useful.

      Plus, for all we know, most males lack a uterus.

    4. Re:49 people + 180 days = proof?? by Kitten+Killer · · Score: 5, Informative

      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

    5. Re:49 people + 180 days = proof?? by Anonymous Coward · · Score: 4, Funny
      Plus, how do they test immunity?
      The subjects engage in sex! Lots of sex! With random people. For science of course.
    6. Re:49 people + 180 days = proof?? by Jahz · · Score: 3, Insightful
      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...

      --
      There are 10 types of people in the world. Those who understand binary and those who do not.
    7. Re:49 people + 180 days = proof?? by RsG · · Score: 3, Funny
      most males lack a uterus.
      And the rest got theirs on ebay?
      --
      Erotic is when you use a feather. Exotic is when you use the whole chicken.
    8. Re:49 people + 180 days = proof?? by AusIV · · Score: 4, Insightful
      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.

    9. Re:49 people + 180 days = proof?? by antifoidulus · · Score: 4, Interesting

      In this case detecting HIV antibodies could very well prove useless. The body may develop HIV antibodies from the vaccine and still not have HIV. You have to measure viral load in the blood, which can be quite tricky.

    10. Re:49 people + 180 days = proof?? by Turakamu · · Score: 5, Insightful

      This being the case, birth defects are definitely not an acceptable consequence.

      Tell that to the gay community.

    11. Re:49 people + 180 days = proof?? by daeg · · Score: 4, Informative

      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 ]

    12. Re:49 people + 180 days = proof?? by Anonymous Coward · · Score: 5, Interesting

      > 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.

    13. Re:49 people + 180 days = proof?? by Chowderbags · · Score: 3, Insightful

      Is it just me, or is it bad that the person directing all this can't remember that HIV doesn't have DNA? It only has two copies of single stranded RNA. For that matter, HIV doesn't come in cells, because it's a virus. I *really* don't want anything to do with this vaccine until it's been tested many times with large samples by independent scientists.

    14. Re:49 people + 180 days = proof?? by gnarlin · · Score: 5, Informative
      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 ;-)

      --
      A bad analogy is like a leaky screwdriver.
    15. Re:49 people + 180 days = proof?? by Score+Whore · · Score: 3, Insightful
      Just think about it... HIV is an INCURABLE disease, which kills %100 of it's victims.


      Does it? Seriously. That's a pretty big claim. You could make the same claim of diabetes. No cure. Without treatment you will die from it. But nobody thinks of it as a fatal condition. AIDS may well become something similar. Look at Magic Johnson, been diagnosed with HIV for 15 years. As far as anyone knows he is quite healthy. Given the way things look for him, at 47 years old he is more likely to die of old age than HIV/AIDS complications.
  2. pool's closed by Anonymous Coward · · Score: 5, Funny

    If this goes well we won't have to close the pools.

  3. HIV by mfh · · Score: 5, Insightful

    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.

    --
    The dangers of knowledge trigger emotional distress in human beings.
    1. Re:HIV by AgentFade2Black · · 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?

    2. Re:HIV by venicebeach · · Score: 4, Informative
      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.
  4. Doesn't it take a little longer? by slapyslapslap · · Score: 3, Insightful

    "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.

    1. Re:Doesn't it take a little longer? by albalbo · · Score: 5, Informative

      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.

      --
      "Elmo knows where you live!" - The Simpsons
  5. Proof of Immunity? by infidel13 · · Score: 3, Interesting

    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?

    --
    quia potentia mens mentis
    1. Re:Proof of Immunity? by jeremymiles · · Score: 5, Informative

      This is the first trial, which means it's a phase 1 trial. Phase 1 trials are not designed to demonstrate efficacy, they are to demonstrate safety. Whether it works or not comes next.

      --
      GENERATION 26: The first time you see this, copy it into your sig on any forum and add 1 to the generation.
  6. Re:49? by debilo · · Score: 5, Funny

    Really, we're supposed to believe the study had exactly 49 participants? Not 50, or 150?

    Pssst, there were 150 participants, but 101 of them died.

  7. Re:Duck and Cover by Anonymous Coward · · Score: 4, Informative
  8. First Phase of AIDS Vaccine Trials Successful by McGiraf · · Score: 5, Funny

    Fuck!

    1. Re:First Phase of AIDS Vaccine Trials Successful by QRDeNameland · · Score: 5, Funny

      "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

      --
      Momentarily, the need for the construction of new light will no longer exist.
    2. Re:First Phase of AIDS Vaccine Trials Successful by McGiraf · · Score: 3, Funny

      That will be a great day for herpes, siphylis, crabs, pregnancies, clamedia ....

    3. Re:First Phase of AIDS Vaccine Trials Successful by MarkRose · · Score: 4, Funny

      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.

      --
      Be relentless!
  9. Booster shots? by tacarat · · Score: 3, Interesting

    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.

    --
    "Common sense will be the death of us all"
  10. Lack of information by Mutatis+Mutandis · · Score: 5, Insightful

    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.

    1. Re:Lack of information by benicillin · · Score: 3, Interesting

      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 somewhat unhappy if they were given the infectuous portions of the disease.

      --
      "i stand on the edge of destruction" -shai hulud
  11. Re:49? by Kitten+Killer · · Score: 3, Insightful

    They probably had 50. (Well, more likely 100, with 1/2 in the placebo group.) One of the non-placebo patients dropped out of the study due to some exclusion criteria not related to the vaccine (such as getting hit by a car) and you end up with the 49. It could even be as simple as the patient having moved to another city. With any clinical trial, you're bound to lose some subjects to follow up.

  12. Re:But I thought... by Pedrito · · Score: 5, Informative

    That this was a slow gestating virus that could lie dormant for years before going into reproductive mode. How does 180 days of "apparent" immunity (with no control group?!?) make a valid experiment?

    Actually, that's not really the case. HIV actually replicates very quickly after infection. Even though one may not show symptoms for many years, that's unusual. Most people develop the first symptoms within weeks of getting the virus. But with or without symptoms, signs of the virus can be found very quickly, particularly in the lymphatic system.

    Do not confuse HIV infection and symptoms with AIDS. One isn't considered to have AIDS until their T-Cell count falls below 200 cells per uL. This is usually the point where the person starts developing the kinds of diseases that normally don't affect healthy people. Before that point, you still has a tendency to get sick from a number of more common illnesses.

  13. Re:Duck and Cover by debilo · · Score: 3, Interesting

    I'd be more interested in genuine scientific proof of the link between HIV and AIDS. There isn't one you know. I've never unterstood this scientific war. People readily believe that a virus causes the common cold, but for some people, there's doubt that HIV causes AIDS?

    Could someone with more insight please explain why there are scientists who deny there's a link?

  14. Re:Umm ... by RsG · · Score: 4, Insightful

    Right, because nobody ever caught aids without having unprotected sex with strangers first. Not one single person, nope. (/sarcasm off)

    What about blood transfusions, broken condoms, infected partners that picked it up via adultery, rape victims and dumb kids who don't know any better (since we don't teach them safe sex, and they're too hormoned-up not to fuck)? That doesn't even get into the mess over in Africa. Are you seriously prepared to condemn every single infected person simply due to the fact that many of the dying got that way from carelessness?

    An ounch of prevention is worth a pound of cure. That doesn't mean however that you can always prevent bad things from happening, or that we shouldn't care enough to try and find a cure.

    And by the way, your arguement can be twisted for just about anything. Why should we try to develop a cure for cancer? Those people should have known to get themselves checked up (many cancers can be detected early, via screening, thereby removing the need for any miracle cure), and should have known to avoid carcinogens (do you check everything you eat?). Yet to take that stance both condemns people for honest mistakes, and condemns the blamelessly unlucky along with the careless by denying them a cure as well.

    --
    Erotic is when you use a feather. Exotic is when you use the whole chicken.
  15. HIV test by Kitten+Killer · · Score: 5, Insightful

    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.

    1. Re:HIV test by Snootch · · Score: 4, Informative

      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.

  16. I Wish They Would Elaborate... by clragon · · Score: 3, Interesting
    "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?
  17. Re:obvious question by MustardMan · · Score: 3, Insightful

    Those are some pretty bold statements to be making without sources. And no, wikipedia is not an acceptable source here, unless it cites some REAL sources.

  18. This is only Phase 1 of 3 by CharonX · · Score: 3, Informative

    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.

    --
    +++ MELON MELON MELON +++ Out of Cheese Error +++ redo from start +++
  19. Well duh this IS Slashdot... by Chaffar · · Score: 3, Funny

    I hate to be a dink, but we've had a way to completely control this infection for about 20 years now; it's called abstinence

    No need to preach abstinence here; we at Slashdot have been abstaining from sex all our lives (not by choice though :)

  20. AYDS by porkmusket · · Score: 3, Funny

    I was overweight and embarrassed to go anyplace. AYDS helped me get back into a size 12.

    Mod me off-topic, I don't care. That video is funny shit.

  21. Re:Umm ... by jgs · · Score: 3, Insightful

    I hate to be a dink

    Doesn't show.

    Why is it important to develop a way to allow people who have little regard for their own health to remain healthy?

    Because compassion is one of the things that makes us human?

    (Leaving aside cold-blooded economic arguments about how you'd much rather have healthy productive workers contributing to your economy than sick people who are draining it. AIDS doesn't make business sense.)

  22. Safety, not Efficacy by adam.conf · · Score: 3, Insightful

    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.

  23. Re:Duck and Cover by yndrd1984 · · Score: 3, Insightful
    Who benefits from the bad science here?
    Where to start?
    Homophobes - The evil gays are spreading disease!
    Alternative therapy peddlers - I can cure AIDS with homeopathic medicine!
    Politicians - AIDS was made by white men to kill black people!
    Jackasses - Sure I'm HIV+ baby, but it doesn't cause AIDS!

    Oh, forget it. This is too easy.

  24. Hats off to those brave test subjects by Robotech_Master · · Score: 4, Insightful

    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.

    --
    Editor Emeritus and Senior Writer, TeleRead.org
  25. Yes, but Manto Tshabalala-Msimang knows better! by slashdotmsiriv · · Score: 4, Interesting

    "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