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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."
Along with the anti-vaccine nutters?
Clearly using real HIV viruses must be very risky and dangerous
That I can tell women that I have the AIDS vaccine at the bar, and can give it to them through intra-muscular administration.
The test for HIV tests for antibodies... So the human body already makes antibodies against HIV... So how are the antibodies for this vaccine different? *These* work? How?
Because if the vaccine is still active in any way, it can't infect anyone further.
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.
It doesn't, but then again that isn't what this stage of testing was about. But hey, I get it - reading to the end of the first sentence of the summary is a lot of work. A busy man like you can't be bothered to invest that much time before rushing off to enlighten us with your genius commentary.
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
It is not found in mankind prior the last 100 years.
In many ways you are misguidedly correct. If the governments of Europe did not initiate their heavy colonisation of Africa during the late 19th century, it is unlikely that AIDS would have ever spread outside of the remote areas of Africa where it orginated and would not likely be the pandemic problem that it is today.
Yup. Phase I results aren't generally considered newsworthy. Pharmaceutical companies have drugs get through phase I trials many times per year. Most turn out to not work, or to have subtle but serious side effects.
The kinds of problems that you can actually spot in Phase I trials are the kinds of problems that would wipe out entire cities if you actually put the pills on store shelves. We're not talking about "maybe causes a 10% increase in heart attack risk" dangerous - more like "causes half those who take it to turn purple and gasp for air" dangerous.
It is the logical first step in testing drugs on people, and it confirms that testing it on sick people isn't going to outright kill a bunch of them, and it helps you to understand how it is metabolized so that you can get the dosing about right when you start the "Real" tests.
They're testing whether or not it's safe, not whether it will be effective.
"Killed virus" means the virus is damaged to the point that they cannot be replicated, but the immune system can still recognize and remember it.
Also don't be the child of someone with HIV, or the wife/husband of someone who gets around (esp in countries where the wife is not in a position to refuse the husband), or be in a country that isn't great with medical sterilisation.
Or don't contract it in a freak incident such as sharing a leg razor with sister, or the other numerous ways the infection has spread through no fault of the infected.
..or get raped by somebody that is infected .Or get a blood transfusion from somebody that turned out to be infected. Or cut yourself on something with blood from an infected person.
Trust the Computer. The Computer is your friend.
Actually, each strain of the virus is unique, and if an infected individual gets infected again with a different strain, it can actually make it worse.
WTF am I doing replying to an AC at 5 A.M on a Friday night?
Easy and cheap, and it works, but it's not a lot of fun. Unknown, untested wet holes are exactly the place you want to be.
WTF am I doing replying to an AC at 5 A.M on a Friday night?
There are *lots* of HIV vaccines in development, many reaching phase I and others going further. There's even one recent phase III showing some evidence of a preventative effect.
For a review check: http://www.ncbi.nlm.nih.gov/pubmed/22710904
From Sumagen's website:
"Sumagen’s HIV/AIDS vaccine is also supported for its R&D cost from the HIV/AIDS vaccine development fund, jointly launched by the Bill and Melinda Gates Foundation and the government of Canada."
"Most turn out to not work, or to have subtle but serious side effects."
Sure but also sometimes (sildenafil citrate) the side effects are so unsubtle that the test objects are reluctant or flatly refuse to give back the rest of the drugs after trial.
"Or get a blood transfusion from somebody that turned out to be infected. "
BTW, that's the reason we don't get any more Isaak Asimov novels.
If you will fuck anything that moves and says yes - well you are engaging in risky behavior.
Definitely. The low-risk choice is to find something that says no, then make it stop moving.
I know I shouldn't (and for all I know the US child support system is totally screwed) but dude, those are his kids, kids cost money and effort to raise, and he needs to provide 50% of both. If he loses his job, then surely these things get re-assessed (I know they do in my country). His kids welfare matters, not his, and if they've been raised by their mother so far, then obviously a judge is going to have her continue to provide that care.
Sorry, but men's choice point over kids is at choosing to have sex, women get a little bit longer than that - but then they have a lot more invested in it. Plenty of women are maimed or die having babies, but I suspect a vanishingly small number of men risk their lives when having sex!
You mean that stuff cures HIV and on top of it I get a fashion sense and a higher mean income? Sign me up!
We used to have a Bill of Rights. Now, with the rights gone, all we have left is the bill.
Oh, and which government do you think had the ability to engineer a lentivirus 100 years ago? Because I'd like them to provide my healthcare...
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