First Human Study of HIV Vaccine Vacc-C5 to begin

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PerfectlyHuman:

--- Quote from: texaninnyc87 on November 23, 2012, 09:49:23 AM ---I'm new to all of this but, if you're on atripla how will they know if it is the vaccine working or your current medication?

--- End quote ---

I will really like to know as well.

Jmarksto:
Perfectly, Texan;

--- Quote from: texaninnyc87 on November 23, 2012, 09:49:23 AM ---I'm new to all of this but, if you're on atripla how will they know if it is the vaccine working or your current medication?

--- End quote ---

--- Quote from: PerfectlyHuman on November 23, 2012, 10:06:37 AM ---I will really like to know as well.

--- End quote ---

First, I am by no means a biologist and not familiar with this study beyond reading the press release. However, based on my understanding the goals of the trial are to evaluate the safety of the vaccine and to see if the immune system responds (making more antibodies and T-cells of a specific kind). Here is a quote from the new release:

"The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers."

They will look for a statistical difference of these endpoints between the group that receives the vaccine and the group that receives the placebo. Technically, they are not expecting or looking for a change in viral load - and a statistically significant change in these endpoints should be seen even if the participants are on meds. Realistically, they will look for changes in any piece of data (including viral load) that they have, but they are not expecting to see a change in viral load.

If they can demonstrate safety, and there is a statistically significant increase in the right kind of antibodies and T-cells, then they would likely go to another Phase II trial (perhaps in combination with Vacc-4x?), then a Phase III trial would need to be done. The point is that we are at least a few more trials away before we know if this really works.

While this is going to take some time, each step in the process is very important - and I really appreciate hubsen's participation in this trial.

Thank you,
JM

hubsen:
I guess they will look for the antibodies in the blood.
As JM wrote, this is a safety study as well as establishing the most suitable dose.
By the way, I had the 4th vaccine today.

tatosao24:
Great Hubsen! Thanks for the news... I thought it would take more time to get to the 4th injection...

sevillano:
Hubsen,
Long time no see;) anything new?

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