Slashdot Mirror
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."
If this goes well we won't have to close the pools.
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.
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.
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.
Fuck!
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
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
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.
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.
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.
This being the case, birth defects are definitely not an acceptable consequence.
Tell that to the gay community.
> 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.
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.