Thursday, September 5, 2013

An HIV Vaccine has SUCCESSFULLY PASSED Phase I trials.

from the Good folks over at Google+:  (hat tip:  LMcGarity)


Making it through the clinical trials system from phase I to phase IV is not a nicely, smoothen road. Regulatory issues are the most common reasons new investigational drugs do not make it to market or are recalled. This HIV Vaccine is apreventable vaccine and data has shown it to be safe in humans and therefore the vaccine has passed the clinical trials Phase I step. Researchers will be moving forward to Phase II clinical trials.
"Sumagen Canada Inc and Western University announced today that the Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed with no adverse effects in all patients. Antibody production was also boosted after vaccination."
Phase I clinical trials are ONLY concerned with the safety of the investigational drug which is usually tested first in a small subset of healthy volunteers. Phase II studies are concerned with safety plus efficacy and thus larger volunteer groups will be needed. The phase II cohorts will also need to include HIV infected or high-risk individuals, in addition to the healthy volunteer groups.