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."

Comments

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