4 ms·
They're placebo controlled. It would be a colossal waste of money to do it any other way. Besides being methodologically unsound, the trials wouldn't be recogni
by schiffern 15y ago
They're placebo controlled. It would be a colossal waste of money to do it any other way. Besides being methodologically unsound, the trials wouldn't be recognized by the FDA or Health Canada.
The University of Rochester has also been working on HIV vaccines for many years. They're always recruiting subjects. The posters are interesting because you can see what stage this particular vaccine is at based on who they're looking for. If they're looking for married, middle-age straight non-injection-drug-users, it's safety trial. If they're looking for young single MSMs or injection drug users, then you know that vaccine has progressed to the efficacy trials.
http://www.rochestervictoryalliance.org/ http://www.rochestervictoryalliance.org/
The 'non-vaccinated' group he speaks of is the placebo group. The reason he mentions it 'head off' anyone assuming they would test it by exposing people to HIV.
- NolF 15y agoThere is no placebo group, it would be highly unethical to do so. Half the sample population gets the treatment half of it doesn't with the option to get the treatment once trial finishes. Changes in behavior due to treatment are accounted via survey pre-treatment and at measuring intervals.
- schiffern 15y agoYou're mistaken: "Phase III would test the effectiveness of the vaccine in a larger group of about 6,000 volunteers who are at risk of becoming infected. Half would be given the vaccine and half given a placebo. Participants would then be tracked for three years to see how many in each group become infected." - http://www.ctv.ca/CTVNews/Health/20111220/canadian-hiv-vaccine-trials-111220/ http://www.ctv.ca/CTVNews/Health/20111220/canadian-hiv-vacci... But more interestingly, why would it be "highly unethical" to do so? They're practicing informed consent, so everyone who gets a shot knows that there's only a 50% chance that they got the real vaccine. And they know that the vaccine isn't guaranteed to work (quite the opposite, in fact, based on the track record of similar trials here in the States).
- ars 15y agoYou are contradicting yourself: "There is no placebo group" vs "Half the sample population gets the treatment half of it doesn't" The "doesn't" is the placebo group. And since every single other HIV vaccine has failed, it's likely that this one will also - so it's not like they are withholding an effective treatment and acting "highly unethical".