GEN-003 - Post By Josh Bloom - [Personal Opinion] Theravax is all we have now.

[Jesus Chuy]

By Josh Bloom — March 30, 2017

A herpesvirus. Image: Shutterstock

A paper in the Journal of Infectious Disease provides clinical data for Genocea's genital herpes vaccine GEN-003. The good news is that infected patients did respond to the vaccine. The not-so-good news is that the response was not impressive. Here is a summary:

In Phase Ia/II trials (1), a total of 134 participants who were infected with HSV-2 were given a total of three injections of 003 three weeks apart. Three different doses of the vaccine were given, and the enrollees received genital swabs for four weeks before administration of the vaccine, and four more weeks after they got the last injection.

Summary of the results:

• The vaccine was safe
• The rate of viral shedding (2) for participants who received the 30 µg dose was reduced from 13.4% to 6.4%
• The rate of viral shedding for participants who received the 100 µg dose was reduced from 15.0% to 10.3%
• Biochemical markers of response, T-cells and viral antibodies, increased after dosing, indicating that 003 did stimulate the immune system
• The rate of lesions in participants who got either the 30 µg or 100 µg dose was cut in half.

Comments:

• A 50 percent reduction in shedding is significant but is unlikely to prevent transmission of the virus during times of asymptomatic shedding. People will still be infectious half as often as they would be without the vaccine. 
• The 33 percent reduction in shedding at the higher dose (100 µg) is less than the 50 percent reduction at the lower dose. This is puzzling. 
•  There is no apparent advantage of GEN-003 over valacyclovir (Valtrex)—the standard of care for treating and preventing outbreaks.

Impressions: From these data, GEN-003 would seem to be disappointing. It is unlikely that the company will be satisfied with a vaccine that works about as well as Valtrex. Given the moderate degree of efficacy seen in infected patients, my guess is that 003 is unlikely to work well prophylactically. Compared to the limited data that is available on Rational Vaccines' Theravax, 003 appears to be inferior** so far. 

**It is too soon to make definitive conclusions about the relative efficacy of 003 and Theravax. The latter has been tested in only 20 people, there were no placebo controls, and the data are not yet published. A direct comparison of the two at this time may or may not be meaningful. Whatever advantage Theravax seems to have may vanish once it is studied in larger trials. I compared the two last year prior to the release of the most recent clinical data on 003.

Notes:

(1)  Phase I trials are usually conducted in a small group of volunteers to determine safety. Sometimes Phase I trials are subdivided - Phase 1a for safety, and Phase 1b for efficacy. In Phase II trials, the drug is given to a larger group of people to see if it is effective and to further evaluate its safety.

(2) Herpes is insidious. People can be infectious even when they are asymptomatic. This means that the virus emerged from the nerve root, but does not lead to an outbreak. Many people are infected with HSV-1 and HSV-2 without even knowing it until they take a blood test. 

[Jesus Chuy]

All we have is Theravax. No other vaccine is showing any signs of improvement. 

[SnowAngel]

I think we all knew that this one was crap...

[LillianPanos]

Wow thanks for posting!

Who is Josh bloom? Seen his name before the science writer

 

[impugn]

What about the Admedus HSV-2 therapeutic vaccine? 

[Jesus Chuy]

Dr. Bloom works for the American Council of Science he writes for them. He has credibility. He also has HSV 1. 

[Evaluate]

17 minutes ago, Jesus Chuy said:

All we have is Theravax. No other vaccine is showing any signs of improvement. 

There are other vaccines in development other than Theravax.  To spew that Theravax is the be all and end all is dangerous to uninformed readers, especially when there are many unanswered questions with that vaccine which the author has partially noted.

On a separate note, everything in that article is already known and is not new information.  It was clear after Phase IIa trials that GEN-003 would not be a saving grace for HSV sufferers.  The author doesn't mention Genocea's intentions of testing GEN-003 alongside antivirals which should be coming up shortly.  I'm won't rehash what's already been stated in other threads, but the general message is this: the more the merrier when it comes to HSV treatment.

[Felina88]

Anti-virals are ineffective on me. I'm excited for GEN-003, not as a potential "cure", but as a treatment option as the amount of treatment options I currently have are zero. Also, there are other vaccines in the works. Amendus seemed optimistic that their vaccine has the capability of becoming more and more effective with boosters, and I think they're even further along in the testing processes as GEN. So, calm your horses. 

[jreemi]

CRISPR will blow all of these vaccines out the water 

[fugazi1]

15 minutes ago, jreemi said:

CRISPR will blow all of these vaccines out the water 

That's what I'm hoping for! 

[Mackie82]

10 hours ago, Felina88 said:

Anti-virals are ineffective on me. I'm excited for GEN-003, not as a potential "cure", but as a treatment option as the amount of treatment options I currently have are zero. Also, there are other vaccines in the works. Amendus seemed optimistic that their vaccine has the capability of becoming more and more effective with boosters, and I think they're even further along in the testing processes as GEN. So, calm your horses. 

Felina you may look at this article if the antivirals don't help you  http://herpescure.m.webs.com/site/mobile?dm_path=%2Fbesttreatments.htm&fw_sig_premium=0&fw_sig_permissions=none&fw_sig_api_key=522b0eedffc137c934fc7268582d53a1&fw_sig_tier=0&fw_sig_session_key=8a25913811b9138286cf29f82afd25e11bfe3055e223d86d9bd3135140129237-80952866&fw_sig_locale=en-US&fw_sig_time=1491047439509&fw_sig_url=http://herpescure.webs.com/&fw_sig_partner=webs&fw_sig=f7eba62396b441a716a2a878d352936f&fw_sig_social=1&fw_sig_site=80952866&fw_sig_permission_level=0&fw_sig_is_admin=0&fw_sig_access_token=a341099739489d4050a94c518b3a592c93c6dc00&fb_sig_network=fw#2102

[VVK]

Why is there no mention about the number of outbreaks? Why is the only measure of effectiveness the rate of viral shedding? Does that include symptomatic and asymptomatic shedding?

[fixme1]

10 hours ago, jreemi said:

CRISPR will blow all of these vaccines out the water 

Ye but it's nowhere near helping sufferers now

[Felina88]

2 hours ago, Mackie82 said:

Felina you may look at this article if the antivirals don't help you  http://herpescure.m.webs.com/site/mobile?dm_path=%2Fbesttreatments.htm&fw_sig_premium=0&fw_sig_permissions=none&fw_sig_api_key=522b0eedffc137c934fc7268582d53a1&fw_sig_tier=0&fw_sig_session_key=8a25913811b9138286cf29f82afd25e11bfe3055e223d86d9bd3135140129237-80952866&fw_sig_locale=en-US&fw_sig_time=1491047439509&fw_sig_url=http://herpescure.webs.com/&fw_sig_partner=webs&fw_sig=f7eba62396b441a716a2a878d352936f&fw_sig_social=1&fw_sig_site=80952866&fw_sig_permission_level=0&fw_sig_is_admin=0&fw_sig_access_token=a341099739489d4050a94c518b3a592c93c6dc00&fb_sig_network=fw#2102

Wow, thank you!

[Jesus Chuy]

15 hours ago, Evaluate said:

There are other vaccines in development other than Theravax.  To spew that Theravax is the be all and end all is dangerous to uninformed readers, especially when there are many unanswered questions with that vaccine which the author has partially noted.

On a separate note, everything in that article is already known and is not new information.  It was clear after Phase IIa trials that GEN-003 would not be a saving grace for HSV sufferers.  The author doesn't mention Genocea's intentions of testing GEN-003 alongside antivirals which should be coming up shortly.  I'm won't rehash what's already been stated in other threads, but the general message is this: the more the merrier when it comes to HSV treatment.

What other vaccines coming out in 2017 or 2018? 

[Evaluate]

55 minutes ago, Jesus Chuy said:

What other vaccines coming out in 2017 or 2018? 

Take a look at the wikipedia page for a list of vaccines in development.

Nothing is guaranteed to come out within a time frame, for various reasons, until clinical testing is complete.

[MoniqueLow]

I am newly diagnosed with ghsv 1 (2 months). I have big pain all the time (back, hip and pelvis), feeling very depressed and done with my life :-( reading about the new vaccine gives me really hope... I really pray for scientific success after many years of research. I think it doesn't matter if it's theravax or other vaccine, important thing is to have solution for the people's suffering. I wish governments realize how big problem is the epidemic of this virus. For some it's just skin condition, for unlucky ones (including me) it is a life of pain ;-( not mentioning relationship issues and social stigma. Wishing the scientists good luck and strength to success.

[Mackie82]

9 minutes ago, MoniqueLow said:

I am newly diagnosed with ghsv 1 (2 months). I have big pain all the time (back, hip and pelvis), feeling very depressed and done with my life :-( reading about the new vaccine gives me really hope... I really pray for scientific success after many years of research. I think it doesn't matter if it's theravax or other vaccine, important thing is to have solution for the people's suffering. I wish governments realize how big problem is the epidemic of this virus. For some it's just skin condition, for unlucky ones (including me) it is a life of pain ;-( not mentioning relationship issues and social stigma. Wishing the scientists good luck and strength to success.

Do you have a nerve pain issues, or some other pain if you have a nerve pain issues we have a private thread for that so i will ask the moderator to add you and you will get a lot of advise and help from the members, not being negative in regards of any vax but I don't believe anymore in any vax. Once the effective vax  is released everybody will come to know . We are talking about these vaccines as if they are on the shelves. I am the most one who needs the vax so I pray something will come out. 

[MoniqueLow]

Thank you, Mackie82. I did research on internet on that topic and found many people having the same problem. It's very scary :-( I am using supplements already (zinc, b complex, selenium, lysine,...) and hope it will get better. Yes, I understand you're sceptical about vaccines, I am too, but it's kind of hope I need to have in my situation right now otherwise I have very black thoughts... I think it's survival instinct :-)

[Gee170]

On 01/04/2017 at 3:36 AM, jreemi said:

CRISPR will blow all of these vaccines out the water 

Yea, maybe in 15 years 

[fugazi1]

4 hours ago, Gee170 said:

Yea, maybe in 15 years 

You clearly have a negative attitude. 15 years? Why 15? Because it isn't available now? Or it won't be tomorrow? So it has to be 15 right? 

[Gee170]

1 hour ago, fugazi1 said:

You clearly have a negative attitude. 15 years? Why 15? Because it isn't available now? Or it won't be tomorrow? So it has to be 15 right? 

Wow, a lot of question marks there  

I seem to have ruffled your feathers my friend, please accept my apologies for being so drastically wrong with my wild stab in the dark, would you please correct me as to when this is due for release to the public? 

Many thanks in advance.  

[Evaluate]

How did you come to 15 years @Gee170?

[Gee170]

3 minutes ago, Evaluate said:

How did you come to 15 years @Gee170?

That should have read 12, looked into FDA approval timelines, see link below, this and a couple other links is what my comment was based on. Apologies if I seemed a negatron, I'm actually quite a positive chap. I truly hope it won't be this long for CRISPR and it's further advanced / in trials etc. 

Do you have any info in regards to its proposed timeline to trials / onto market? 

https://www.drugs.com/fda-approval-process.html

[Atrapasueños]

La FDA esta para proteger a la población pero creo que abusan de sus normas hay países que tiene menos jurisdicción

 

The FDA is to protect the population, but I think that there are countries that have less jurisdiction