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."

Re:subjects were already infected

[slew]

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 [wikipedia.org]

Re:subjects were already infected

[Rich0]

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.

It's not.

[mosb1000]

They're testing whether or not it's safe, not whether it will be effective.

Re:Details?!?

[Anonymous Coward]

"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.

Re:my vaccine already works

[Anonymous Coward]

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.

Re:my vaccine already works

[JanneM]

..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.

Re:my vaccine already works

[nospam007]

"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.

Re:Does that mean

[grinchier]

I have lived in Africa my whole life and that CIA plot thing is old. It's now a "plot by multi-national pharmaceutical companies". At least, it was during Thabo Mbeki's tenure as South African president (http://en.wikipedia.org/wiki/AIDS_denialism#In_South_Africa). AIDS awareness is alive and well here.