New shingles vaccine xtraordinarily effective

[Beachdude1984]

https://finance.yahoo.com/news/positive-outcome-phase-3-study-120000999.html

 

New shingles vaccine 97% effective in preventing shingles as shown in a large phase 3 study.

What's so unique is this is the first subunit vaccine that has been successful, after dozens of failed subunits (including several for HSV). Also contrary to historical vaccine development, this vaccine is vastly superior to its live virus vaccine counterpart, which is only 50% effective in preventing shingles. After numerous failed subunit HSV vaccines, there was growing concern that the only path to a successful HSV vaccine would be the live virus route (of which there are none in clinical trials- all of the current HSV vaccine ex in clinical trials are subunit except ACAM 529, which is a dead virus vaccine). This shingles vaccine proves that a subunit HSV vaccine may indeed be possible, especially considering HSV and shingles are closely related. The founding company, Agenus, has a HSV vaccine in clinical trials now that uses the same adjuvant and is based on the same premise as its shingles vaccine. This is great news for all of us here.

[ShaeShae]

Wonderful news!

[rainyfeather]

Great to hear

[Fairisle]

This is absolutely fantastic!!!!

[WCSDancer2010]

Another step in the right direction!

[Getbetter111]

I talked with the company about gen-003 she said all goes good should be available in 2016? Will see!!

[WCSDancer2010]

Well, lets hope so ... but as someone who has seen a lot of trials/etc shut down by the FDA in my 35 yrs with H, I'll believe it when I see it out there ...

 

I DO believe that we will get something in the next 5-10 yrs ... simply as a by-product of Shingles and HIV studies ... much of how they come up with vaccines there will transfer to finding one for HSV ..... which reduces the time and expense of coming up with something that many of them consider a non-life-threatening (and thus less urgent) issue.

 

Also, the first vaccines usually are not the "best" in the long run (just as with the Shingles vaccines ... ) ... so we have a bit of a way to go before we get a true cure ... but the really, really GOOD news is that there seems to be a number of smaller drug companies who are trying to break into the market who are working on coming up with something that will work. Until relatively recently Big Pharma controlled most of the trials ... competition to break into the field will be very advantageous for us in the long run :)

 

Just want to remind you to remember to live your live TODAY .... don't hold out on love waiting for a vaccine ... because if *I* had, I'd never have met the 3 lovely men who have graced my life ... and even tho they didn't work out, they brought a lot of good things to me and I learned a lot about myself with them.....so don't deny yourself of love if it comes your way :)

 

(((HUGS)))

[Beachdude1984]

@getbetter

 

Genocea's vaccine is meant to be therapeutic, not preventative, and the preliminary data is not encouraging (42% reduction in outbreaks at 6 months post-injection, return to baseline 12 months post-injection). This would make Gen 003 less efficacious than Valtrex. Genocea is running another trial with altered dosing and adjuvant, and this data will be available next year. They will also be recording shedding rates during this trial.

 

Sanofi-Pasteur, Agenus, and Admedus are all working on prophylactic (preventative) vaccines. Personally I would much rather a preventative vaccine be found. This will do infinitely more to reduce stigma and mitigate risk than any therapeutic vaccine ever could.

[seeker]

therapeutic would be nice but a bigger market is in preventative and if you really think about it would help with those of us who have H. meet someone, grow to like them, disclose; either they have had the shot OR they go get the shot and no worries.

 

I know it doesn't help those of us with H but imagine a world where it wouldn't matter.

 

of course the moment a preventative comes along all research stops on therapeutic as it would be a dwindling consumer base over time.

[john]

it was may 2013 fda shut down pritelivir testing because of monkeys having problems with 900 times the human dosage. has there been any pritelivir updates? thanks.

[seeker]

not that ive heard of. that's the one that damned near made my head explode. 900 x the normal dosage??? last I checked water was toxic at that level, its called drowning.

[john]

that was the research I read, in many journals, and dr. wald in seattle was none too happy about it. (seemed to be extraordinarily safe, effective, and really knocked down silent shedding rate. check it out, don't take my word for it.

[mr_hopp]

I just happened to see this today while doing some winter cleaning and thought this would be a good thread to throw it in on. :)

 

For anyone interested in knowing the drug testing process from development to approval, I found this graphic in some of my paperwork that shows the phases and timelines:

http://screencast.com/t/O5TidyhLE

[john]

adrial, I neglected to mention 157 humans had been through the course with no medical problems. sorry

[seeker]

so the one we are discussing was 1.5 years away because it was in ph3? and all because some monkeys got skin conditions at 900x the dosage? why the hell would monkeys want to take it anyway?

 

@ john, yea I had read up on that one. if I remember it was either 1 400 mg pill a week or 1 75 a day and almost no shedding and nearly no OBs.

[john]

medication not vaccine

[john]

seeker, correct.

[Beachdude1984]

@john

 

No there are no updates from the FDA standpoint. In all likelihood the hold will not lifted. There is a rumor that the developing company, in a last ditch effort to get the drug approved, will apply for orphan drug status to treat people with acyclovir-resistant strains of HSV. Unfortunately this means the drug will not be available to most of us, unless you can convince a doctor to prescribe the medication off label. And even then, insurance will not cover off label meds, so it will be ridiculously expensive.

 

On the bright side, a similar drug, ASP 2151, with the same mechanism of action (helicase inhibitor) as pritelivir, is in stage 3 trials in Japan. Even if approved in Japan, if/when it is approved here is anyone's guess. The chickenpox vaccine we know give our children was approved in Japan 17 years prior to being approved here.

[whitedaisies]

How do u prove that u have an acyclovir resistant strain?

[Beachdude1984]

@ white daisies

 

http://depts.washington.edu/hivaids/derm/case2/discussion.html

 

"The first goal is to establish the diagnosis of HSV. If acyclovir resistance is suspected, testing for HSV should include a viral culture of the sample, since resistance testing will require isolation of virus. Laboratory testing for acyclovir resistance includes a variety of phenotypic assays, such as the plaque-reduction assay, dye-uptake assays, and viral DNA-inhibition assays[5]. Among these assays, the plaque reduction assay is the most frequently used and resistance is characteristically defined as an IC50 greater than 2 ug/ml[5], with non-resistant isolates typically having an IC50 of approximately 0.1 ug/ml[3,12]. Within a single lesion, heterogeneous virus populations may exist composed of susceptible and resistant strains."

 

You may have to contact UW to find out where to actually go if you are interested in acyclovir resistance testing.

[Beachdude1984]

Interestingly and almost paradoxically, acyclovir-resistant strains of HSV-2 are characteristically less virulent than non-resistant strains.

[whitedaisies]

Thank u beach dude!