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fh12

genocea Gen 003 Vaccine update from volunteer

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I am in the Genocea study for a vaccine and I wanted to let you know ...

herpes.supportgroups.com/.../i-am-in-the-genocea-study-for-a-vaccine-and-i-wanted?... - Cached This is a volunteer's experience with the Gen 003 vaccine please read all the comments as she updates there also. Please note that the HSV 1 exclusion is for a history of genital HSV1 not oral. This is great news! The comments on this site are six pages to date!

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we dont know if it works at all... The young lady reports good news , however this is preliminary.. dont want folks to get overhyped for disappointment. Im pulling for this to work like evryone else but wanna avoid rumors starting.

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It has only been a few months for her so this is very new and we have to be patient. So far, her results are positive. This is Phase 1 which is the first testing on humans and we will not have all the data from this clinical trial until sometime in 2014. This is ONLY being tested on HSV2.

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... but you will have some data before then right? I don't want to wait another whole year for some info.

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I don't think Genocea will release anything before the trial is over but I am not 100% sure. You can email Chip Clark and ask him in another thread on this site. This person is the only one who has posted at this point on her results from the Gen 003 vaccine and she is keeping us updated per her comments.

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Unless they have a non disclosure clause in the documents a volunteer must sign, I don't see why they can't post their results. They do tell the volunteers for this trial what dosage they will be getting but keep in mind there are 6 different vaccine formulations as well as the placebo.

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"Subjects will receive 3 doses of the assigned treatment (GEN-003/M-2, GEN-003, or placebo) at 3 week intervals. Sampling from mucocutaneous genital sites for viral shedding will be done twice daily for 28 days prior to the first immunization (baseline shedding), and again following the last immunization. Follow-up for safety monitoring will be conducted for 12 months after the last immunization."

Sorry if this is a dull question but in the comments thread in the link posted the lady says how the stronger vaccine is being tested now, so if the three shots are finished by march ish time - then they wait 12 months to checks its safe, does that mean if all goes wel that this vaccine could be publicly available as soon as next year at some point???

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they would go on to a phase 3 which will be testing a massive group (thousands) ... THEN FDA would get involved to do their part after that... 2015 sound like the more realistic situation at the earliest

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In the attention all members of this site ( Genital Herpes campaign ) , Chip Clark , CEO of Genocea, addresses the clinical trial process and time frame for approval. He states between 2017 and 2020 for release of the drug to everybody if it passes the trials.

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Bummer, although if it works its all good!! guessing its pretty unlikely anything else will be approved before then either?

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I just spoke to the GEN003 site out in Texas and apparently they need more volunteers with HSV2 to proceed with the study. We need to spread the word, the sooner people get in their the sooner they can complete the trials and go to market...

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To summarize, this volunteer received the Gen 003 vaccine in early October 2012 and has not had any symptoms since. She has stopped all antivirals (this is necessary for the trial) and supplements as well as not limiting her diet anymore. She had monthly symptoms before the vaccine. She was in the mid dose group, 30ug.

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Correct me if im wrong, but i remember seeing someone on this site had posted that if a trial proves effective and beneficial during the phase II trial the FDA can approve the vaccine to be used on all patients? I spoke to the lab in TX the one doing the injecting and they said if it proves effective that the FDA can approve the vaccine to be used on all patients during their phase III. Does anybody know of this?

THanks

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Yes the decision is up to them .. depending upon the results.. If the results are extremely satisfying.. there's a chance.. Truth is none of us know , even these companies.. we may see something happen out of the norm.. It's going to take a hell of an amount of success in Phase 2 trials..

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Well I just talked to a rep at a site involving the GEN-003 trials.. We both agreed it would be incredibly expensive to participate by flying back and forth to their office.

I'm going to continue to be optimistic while being patient, although its tough. She stated that since this is the first time this has been tested on humans it will be YEARS and YEARS before anything would become publicly available.. The truth is SHE DON'T KNOW EITHER.. so I'm not going to let that statement bring me down.. I've seen alot of things happen in life that were more serious than H.. Miracles do happen where I'm from..

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Herp V from Agenus is in Phase 2 trials now. They are also taking volunteers. They already did a Phase 1 trial. Hopefully, if there are further studies with either of these vaccines, they will expand the areas where volunteers can participate.

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No, then it can take 6 months to a year to disseminate the research data, and prepare reports and various other materials

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That is not what the volunteers are hearing. They are being told it may be in more locations in Phase 2. See the thread listed above, the comments section.

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Usually Phase 3 is the BIG BOY.. spread out to thousands of folks.. they may add a couple sites in Phase 2

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This participant for Gen 003 is continuing to have good results, no signs of the virus. See support groups genocea , the comments section to follow her progress. I wish we also had a HerpV participant to follow.

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fh12, thanks for the update, can you tell me how to get to this genocea support group page? thanks.

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