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First Phase of AIDS Vaccine Trials Successful
Posted by
ScuttleMonkey
on Sun Aug 20, 2006 02:57 PM
from the baby-steps dept.
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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49 people + 180 days = proof?? (Score:4, Interesting)
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)
Re: (Score:3, Insightful)
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Plus, for all we know, most males lack a uterus.
Re:49 people + 180 days = proof?? (Score:4, Funny)
Re:49 people + 180 days = proof?? (Score:5, Insightful)
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.
Re:49 people + 180 days = proof?? (Score:5, Insightful)
Tell that to the gay community.
Re:49 people + 180 days = proof?? (Score:5, Informative)
Re:49 people + 180 days = proof?? (Score:5, Interesting)
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.
Re:49 people + 180 days = proof?? (Score:5, Informative)
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 ;-)
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Re:49 people + 180 days = proof?? (Score:5, Informative)
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
Re:49 people + 180 days = proof?? (Score:4, Insightful)
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...
This is only Phase 1 of 3 (Score:4, Informative)
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.
Re:49 people + 180 days = proof?? (Score:4, Funny)
Re:49 people + 180 days = proof?? (Score:5, Interesting)
Re:49 people + 180 days = proof?? (Score:4, Insightful)
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.
Re:49 people + 180 days = proof?? (Score:4, Insightful)
pool's closed (Score:5, Funny)
HIV (Score:5, Insightful)
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.
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Re:HIV (Score:5, Informative)
Doesn't it take a little longer? (Score:3, Insightful)
Re:Doesn't it take a little longer? (Score:5, Informative)
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)
Re:Proof of Immunity? (Score:5, Informative)
First Phase of AIDS Vaccine Trials Successful (Score:5, Funny)
Re:First Phase of AIDS Vaccine Trials Successful (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
Re:First Phase of AIDS Vaccine Trials Successful (Score:4, Funny)
Re:First Phase of AIDS Vaccine Trials Successful (Score:5, Funny)
I felt a disturbance in the force. It is as if the fantasies of millions of slashdotters were suddenly silenced.
Booster shots? (Score:3, Interesting)
"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.
Lack of information (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.
HIV test (Score:5, Insightful)
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)
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].
I Wish They Would Elaborate... (Score:3, Interesting)
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?
Hats off to those brave test subjects (Score:5, Insightful)
For the equivalent of $250.
Damn.
Yes, but Manto Tshabalala-Msimang knows better! (Score:4, Interesting)
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?ne
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Re:49? (Score:5, Funny)
Pssst, there were 150 participants, but 101 of them died.
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Re:Duck and Cover (Score:4, Informative)
The Evidence That HIV Causes AIDS [nih.gov]
HTH. IHBT. HAND.
Re:Duck and Cover (Score:4, Interesting)
Could someone with more insight please explain why there are scientists who deny there's a link?
Re: (Score:3, Informative)
(Don't forget to mod me down - I said something bad)
No. You just said something that most intelligent people consider stupid, knowing that most Slashdotters (who, in all honesty, are not really as smart as they think they are) will consider it stupid as
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No, because, well, you know, viruses cause diseases, they don't mutate into diseases. Even if we're laymen and not scientists, we should choose our words more carefully so as to not sp
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It would be nice if someone did a control first to see if people infected with HIV actually die.
To this date, noone has managed to live forever (i.e. not die). Please post evidence that people infected with HIV life forever.
Re:obvious question (Score:4, Insightful)
Re:But I thought... (Score:5, Informative)
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.
Re:Umm ... (Score:5, Insightful)
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.
Well duh this IS Slashdot... (Score:4, 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 :)
Re:Umm ... (Score:4, Insightful)
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.)