Gen-003

[JHenry]

I might be late to the party seeing this, but I saw this today in ACSH by Josh Bloom.

Herpes Vaccine GEN-003: Back In The News, But The News Isn't Great

"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 as impressive as patients would hope. 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 have an uphill battle. Based on my experience, It is unlikely that the company (and future investors) will be satisfied with a vaccine that works about as well as Valtrex. Given the moderate degree of efficacy seen in infected patients, 003 seems unlikely to work well prophylactically.

There are other herpes vaccines in the works but this is the most advanced, having done clinical trials. You can read about other herpes vaccines here.

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. 

[lali]

I've lost all hope..

[RVX Patient and Investor]

there is no reason to have lost all hope.  @Agustin Fernandez III has said sales of theravax will start THIS MONTH.  so that alone is reason to have hope.

in my exchange with Chip Clark in his thread (the guy behind gen3) i already ascertained that he was basically hoping for nothing better than what AVs give someone already.  his rationale was that this was better than popping pills, and/or an alternative for those who AVs don't work on.  thats fair enough, but given the obscene amount of money gone into their work, thats setting the bar far too low imo.

here is the first thread to talk about this article:

 

[fixme1]

It's a shame they've wasted money in tech they knew glaxo had failed with. It's sickening 

[Cas9]

5 hours ago, JHenry said:

I might be late to the party seeing this, but I saw this today in ACSH by Josh Bloom.

Herpes Vaccine GEN-003: Back In The News, But The News Isn't Great

"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 as impressive as patients would hope. 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 have an uphill battle. Based on my experience, It is unlikely that the company (and future investors) will be satisfied with a vaccine that works about as well as Valtrex. Given the moderate degree of efficacy seen in infected patients, 003 seems unlikely to work well prophylactically.

There are other herpes vaccines in the works but this is the most advanced, having done clinical trials. You can read about other herpes vaccines here.

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. 

Yes, you are late to the party. The phase II results have been out for a while and are considered positive, not negative, and is why Gen-003 will be entering phase III soon. The fact that the vaccine is equal to daily valtrex is also well established. Gen-003 came right out and stated this already. So you now have a choice; take valtrex twice a day, everyday (which equals 730 pills a year), or take a couple of shots a year. Obviously the latter is the better choice. That's the beauty of the vaccine. Furthermore, it is believed that the vaccine plus valtrex may reduce OBs even more. That will also be studied.

If Gen-003 is successful in phaseIII, it will be the first to hit the market (around 2020). It is a therapeutic and does is good job, assuming it continues with the same results through phaseIII. It will also be the best vaccine so far. No other vaccine has done that well. But it is not the end all be all. It's a step in the right direction. There are many other vaccines that will follow that have different approaches and hopefully will do an even better job.

[Cas9]

5 hours ago, lali said:

I've lost all hope..

So lali, what do you plan on doing now that you've lost all hope?

[lali]

Depresse? If its like taking valtrex its not worth it. Really depends on how much it cost. It doesnt do much more. 

[Evaluate]

For the sake of keeping conversations together, I'm locking this thread as there is already another one started on this very topic here: