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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."
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.
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The Evidence That HIV Causes AIDS
HTH. IHBT. HAND.
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, 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.
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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
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.
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 +++
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.
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 ]
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.