GS-US-330-1401

[DMach921]

I just received an email from the trial team that they are now recruiting at Tufts for this clinical trial. I am intrigued by this trial.. Anyone have any thoughts on this??

Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

[StephenCastlecrag]

Your doctor should find out, if he is the liver specialist, he should know. An infectionist is not necessary a liver specialist.

[melcul]

I am also from romania which is included in the trial gs4774. My doctor which is from the hospital mentioned there was not informed about it. and he is an infectionist .he searched ob clinicaltrials.gov and saw his hospital but he is not up to date. He was surprised...where should i ask..

[StephenCastlecrag]

GS4774 is a therapeutic vaccine, developed by GlobeImmune and licensed exclusively to Gilead. The science behind this vaccine is very sound. I believe the vaccine consists of dead yeast cells genetically modified to express 3 HBV viral antigens (X, S, and C). As you know, China had conducted two therapeutic vaccines clinical trials, one was a failure, the other was not spectacular. Both of these vaccines targeted the S antigen However, the Cuban has developed a successful vaccine, NASVAC, now taken over by a French company, ABIVAX, and renamed ABX203. This vaccine targets the C antigen.
Personally, I believe all therapeutic vaccines can illicit specific T cells response, however most of them are not effective because the HBV has long evolved mechanisms to inhibit these immune cells, such as ones leading to T cells exhaustion.
Having said that, GS4774 targets the X and C viral proteins, and to me, this sets this vaccine apart from the others.
Also, now most immuno-therapies, including therapeutic vaccines, are tested in conjunction with existing oral antivirals that can suppress serum hbvdna, a inhibiting factor of the immune system.
So, we have high hope for GS4774, yours is the second Phase 2 trial, recruiting only treatment naive patients. I think you should definitely consider this opportunity carefully. Because I think there is a control group, so you may not be assigned to the TDF + GS4774 group. Do find out, if GS4774 works successfully then those in the control group will also be offered the vaccine later.

These are just my personal opinions. Do keep us informed if you decided to take part.

[luckyman316]

Interesting... here's a link. May ask my doctor about this when I am there, since I'm already on a Gilead clinical trial. I'm sure there are plenty of pre-requisites for it too.

http://www.globeimmune.com/infectious-disease/gs-4774/

[DMach921]

No the email I received was from the gilead team. I emailed them regarding the trial.. If you go to www.clinicaltrials.gov website and put in the trial number you can email the gilead team.. I emailed them because I am in Massachusetts but the hospital was not yet recruiting. They replied back and informed me that they are now recruiting. I'm seriously considering applying for the trial.

[mike9111]

Do you have any details on who is the contact and in which country?