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HIV Vaccine Safe Enough To Pass Phase 1 Human Trials
An anonymous reader sends this excerpt from Western University in Canada:
"The first human applied clinical study (SAV CT 01) using a genetically modified killed whole-virus vaccine (SAV001-H) to evaluate its safety and tolerability was initiated in March 2012. This study is a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. Infected men and women, 18-50 years of age, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo. Sumagen announced today the patient enrollment has progressed smoothly and there have been no adverse effects observed including local reactions, signs/symptoms and laboratory toxicities after SAV001-H injection in all enrolled patients to date. With these interim results, the SAV001-H has proven safety and tolerability in humans and given Sumagen confidence for the next clinical trials to prove its immunogenicity and efficacy evaluation."
Phase 1 trials are the "prove the vaccine doesn't give you AIDS" (or cause other medical problems) stage of things.
"They redundantly repeated themselves over and over again incessantly without end ad infinitum" -- ibid.
I find it interesting that all the subjects were already HIV positive. It looks like this study only shows that it is ok to inject into a human, not that it does anything useful.
That is all Phase I testing is: identify a safe dosage range and screening for side effects...
Phase II, they will be attempt to determine if it does anything useful.
http://en.wikipedia.org/wiki/Clinical_trial#Phases
That's not the problem. Believe it or not, the problem is getting them to use it. My father has worked in Africa for more than 20 years now and there is a massive amount of distrust for this sort of thing among the native populations. Many average people even think this type of thing is a CIA plot to kill them off. With the things people have done to them over the centuries, I'm not terribly surprised, but there has been a lot of effort over the last few generations to fix that, and yet it still remains. It won't be easy to overcome.
As I understand it, humans will always produce antibodies to fight infections like HIV. Unfortunatly, the antibodies that humans normally produce in the attempt to neutralize and HIV infection don't appear to be very good at it. The short story is that somehow HIV evolved to avoid having many fewer binding locations so the most effective "Y" shaped antibodies cannot effectively attach bivalently (in two places). This bivalent attach is apparently the most common strategies used by our immune system.
Apparently some people can make more potent antibodies called bNAbs, but often HIV mutates to avoid these as well, but sometimes there are successes.
I'm unclear on why this new Canadian/Korean HIV vaccine would be any better at bootstrapping the immune system than the most recent failed attempts. The only novel part that I can tell about this, is that they are using "whole" (but genetically modified) HIV instead of putting HIV protein genes codings into more common viruses, but if HIV is as crafty as it seems to be, this may only be a simple shot-in-the-dark hope that somehow bootstrapping the immune system will allow the body to come up with a way to fight off HIV before it gets a chance to overwhelm the immune system. Color me skeptical as that was what the other vaccines attempted to do, but it's not clear that this will be a successful route.
At least it would be very easy to identify safe sex partners. If it moans and feels like a corpse... uh...
Damn, my last girlfriend... I think I should get checked.
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.