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StayingUpbeat

The Next HSV-529 Live Attenuated Therapeutic Vaccine Clinical Trial Has Begun

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StayingUpbeat

A new, rather complex, therapeutic vaccine clinical trial is now recruiting: https://clinicaltrials.gov/ct2/show/NCT04222985.  Finding details of the actual formulations of the 4 vaccines being tested has been (at least for me) unfruitful.  This is however, definitely the output of the Sanofi Pasteur HSV-529 vaccine collaboration with Immune Design.

For those that haven't been following the story...

What eventually became HSV-529 started as a development effort by Harvard Virologist David Knipe and the NIH.  It was licensed for continued commercial development by a small biotech named Acambis (who named it ACAM-529).

In 2008 Acambis was acquired by Sanofi Pasteur (the 8th largest pharmaceutical company in the world) at a price of $546M and the vaccine was renamed HSV-529.

In 2013 Sanofi kicked-off a Phase I clinical trial of the HSV-529 vaccine at the NIH in Maryland. On a personal note I participated in this clinical trial.  The trial yielded reasonably good results but doesn't appear to be the home run Sanofi was hoping for.

In what can only be described as a massive step backwards; in 2014 Sanofi divested the HSV-529 vaccine to a small biotech named Immune Design in what was ostensibly characterized as a "collaboration".  It was an odd decision in many respects not the least of which being that Immune Design already had a protein subunit HSV vaccine candidate named G103 in their pipeline. https://www.sanofi.com/en/media-room/press-releases/2014/2014-10-16-07-00-00

The divestment was almost certainly a result of the firing of Sanofi's outspoken CEO Christopher Viehbacher who championed acquisition of Acambis (the company that originally began development of the HSV-529 vaccine).  He even took the bold step of relocating his primary office to the newly acquired company's Massachusetts location.  It's rumored these decisions combined with a couple poorly performing financial quarters sealed his fate (and unfortunately the fate of the HSV-529 vaccine as well)

As if this story couldn't get any stranger Immune Design was acquired in February of 2019 by Sanofi competitor Merck (the 3rd largest pharmaceutical company in the world) to the tune of $300M.

The currently recruiting clinical trial still lists "Immune Design" and "Sanofi Pasteur" as the clinical trial sponsors.  I'm not sure if that is simply an artifact of when the Clinical Trial submission paperwork was filed or the clinical trial sponsors will be updated to Sanofi Pasteur & Merck but this is clearly the result of the HSV-529 "collaboration".

More importantly, and equally unclear, is what is actually in the 4 formulations of this clinical trial.  Is it the HSV-529 vaccine? Immune Design's G103 vaccine? Both in different dose levels?

If participating in the trial it's the first thing I would ask but, given the companies involved, this is still likely the best HSV vaccine clinical trial that is going to occur in 2020.

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hk81

Any interested candidate can ask for those informations, for his safe choice.

If this is a Phase 2 trial, then they must give reference for the Phase 1 trial and results. If it is a Phase 1, I assume that it's a new formulation.

On the trial they write Phase 1 Phase 2. I wonder what that means. Are they running both phases together?

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StayingUpbeat
16 hours ago, hk81 said:

On the trial they write Phase 1 Phase 2. I wonder what that means. Are they running both phases together?

That's exactly what that means.  They are running what is known as a Phase I/II trial.  The primary endpoints are both safety (Phase I) and efficacy (Phase II).

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hk81

Thanks! I didn't know that it was possible.
Then it's probable that it's not the old HSV-529 vaccine.
I suppose that they combine the 2 phases to reduce the timeline to market, or?

You said that you participated to the HSV-529 trial. Did you have any improvement on your condition?

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iFdUp
6 hours ago, hk81 said:

Thanks! I didn't know that it was possible.
Then it's probable that it's not the old HSV-529 vaccine.
I suppose that they combine the 2 phases to reduce the timeline to market, or?

You said that you participated to the HSV-529 trial. Did you have any improvement on your condition?

Might just be more cost effective for them to do multiple formulations at once, measuring for safety as well as efficacy to save time & money. 

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Voyager2

the world's slowest vaccine program...

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MikeHerp
On 1/15/2020 at 1:38 PM, StayingUpbeat said:

A new, rather complex, therapeutic vaccine clinical trial is now recruiting: https://clinicaltrials.gov/ct2/show/NCT04222985.  Finding details of the actual formulations of the 4 vaccines being tested has been (at least for me) unfruitful.  This is however, definitely the output of the Sanofi Pasteur HSV-529 vaccine collaboration with Immune Design.

 

This is good news.  This vaccine got around $1 million funding in 2018 from the NIH.  That to me was pretty good evidence that it is still very much being considered.  

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MikeHerp

This raises the possibility that a therapeutic vaccine could be approved within around 5 years (or even slightly less).  

No other HSV vaccine is this advanced (not counting ones that are completely stalled).

The Einstein vaccine (which is the one I have always favored), is still a little ways away from clinical trials.  What is known is that they have money for, probably phase 1 and 2.  So it will proceed, but they haven't even started phase 1 yet.  

UPenn vaccine seems also likely, but their funding seems less certain.  They are around 1 to 1.5 years away is my guess.  

The nice thing about the Sanofi vaccine is that, Sanofi has huge resources.  Sanofi is one of the biggest players in the pharma market and they have deep pockets.  They won't abandon this for lack of money.  GSK, another pharma behemoth, was able to take their prophylactic all the way deep into phase 3 (at a cost of over half a billion dollars).  If Sanofi wants to do it with this vaccine, money won't be a limit.  One of the problems with HSV vaccines, is that many of them have been developed by companies that are tiny fringe bit players.  The reality is that, most of those companies don't have a chance in the world of getting a vaccine past a phase 3 and commercialization finish line.  But Sanofi can.  

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veagle

StayingUpBeat, are you participating in the Phase 2 trial too? 

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StayingUpbeat
On 2/14/2020 at 12:58 PM, veagle said:

StayingUpBeat, are you participating in the Phase 2 trial too? 

I am not. Though I did find out (after the HSV-529 Phase I trial was complete) that I received the vaccine and not the placebo.

With the exception that my prodrome to an outbreak now includes a fever I haven't noticed any symptomatic difference.

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veagle

so you've vaccinated, does it have any effect or change anything for you?  as what they state the vaccine should be doing? less outbreak, less shedding, or stuff like that?

I'm assuming phase 1 and phase 2 are the same vaccine they injecting people with... 

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thethinker82

Hi there

Here follows a nice little addition from my side to that very interesting topic.

It seems that @StayingUpbeat was not right in his assumption that this new NCT04222985 HSV trial is G103 only. According to the following response from the Sanofi Trial Transparency Team the new NCT04222985 trial includes several combinations of G103 and HSV529. So this means that the HSV529 vaccine is also in 2020 not dead. 😀

However, what I don't understand is why previously HSV529 vaccinated volunteers cannot participate in the new trial...

Full reply of my NCT04222985 request:

Dear Sir or Madam:

Thank you for your e-maill and query on the clinical trial NCT04222985, HSV15, Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2.

The primary purpose of this mailbox is to provide patients interested in participating in clinical trials with relevant information.

Participants of the study NCT01915212 could be allowed in this new clinical trial NCT04222985 depending on the arm in which they participated. Participants having received HSV529 cannot participate in the new trial, while participants having received Placebo can be enrolled.

The clinical trial NCT04222985 includes several combinations of HSV529 and G103, with adjuvant in different concentrations in order to select a final vaccine candidate.

These two Sanofi trials are not related to each other. NCT01915212 was initiated by investigator and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), with Sanofi Pasteur’s collaboration.

NCT04222985 is a Phase Ib/IIa study sponsored by Sanofi Pasteur.

We hope that the above information is useful to you.

Yours truly, 

Trial Transparency Team

Clinical Sciences and Operations

Sanofi

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Star33hcs
3 hours ago, thethinker82 said:

Hi there

Here follows a nice little addition from my side to that very interesting topic.

It seems that @StayingUpbeat was not right in his assumption that this new NCT04222985 HSV trial is G103 only. According to the following response from the Sanofi Trial Transparency Team the new NCT04222985 trial includes several combinations of G103 and HSV529. So this means that the HSV529 vaccine is also in 2020 not dead. 😀

However, what I don't understand is why previously HSV529 vaccinated volunteers cannot participate in the new trial...

Full reply of my NCT04222985 request:

Dear Sir or Madam:

Thank you for your e-maill and query on the clinical trial NCT04222985, HSV15, Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2.

The primary purpose of this mailbox is to provide patients interested in participating in clinical trials with relevant information.

Participants of the study NCT01915212 could be allowed in this new clinical trial NCT04222985 depending on the arm in which they participated. Participants having received HSV529 cannot participate in the new trial, while participants having received Placebo can be enrolled.

The clinical trial NCT04222985 includes several combinations of HSV529 and G103, with adjuvant in different concentrations in order to select a final vaccine candidate.

These two Sanofi trials are not related to each other. NCT01915212 was initiated by investigator and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), with Sanofi Pasteur’s collaboration.

NCT04222985 is a Phase Ib/IIa study sponsored by Sanofi Pasteur.

We hope that the above information is useful to you.

Yours truly, 

Trial Transparency Team

Clinical Sciences and Operations

Sanofi

Do you know if they Will work for Ghsv1?

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iFdUp
14 hours ago, thethinker82 said:

Hi there

Here follows a nice little addition from my side to that very interesting topic.

It seems that @StayingUpbeat was not right in his assumption that this new NCT04222985 HSV trial is G103 only. According to the following response from the Sanofi Trial Transparency Team the new NCT04222985 trial includes several combinations of G103 and HSV529. So this means that the HSV529 vaccine is also in 2020 not dead. 😀

However, what I don't understand is why previously HSV529 vaccinated volunteers cannot participate in the new trial...

Full reply of my NCT04222985 request:

Dear Sir or Madam:

Thank you for your e-maill and query on the clinical trial NCT04222985, HSV15, Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2.

The primary purpose of this mailbox is to provide patients interested in participating in clinical trials with relevant information.

Participants of the study NCT01915212 could be allowed in this new clinical trial NCT04222985 depending on the arm in which they participated. Participants having received HSV529 cannot participate in the new trial, while participants having received Placebo can be enrolled.

The clinical trial NCT04222985 includes several combinations of HSV529 and G103, with adjuvant in different concentrations in order to select a final vaccine candidate.

These two Sanofi trials are not related to each other. NCT01915212 was initiated by investigator and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), with Sanofi Pasteur’s collaboration.

NCT04222985 is a Phase Ib/IIa study sponsored by Sanofi Pasteur.

We hope that the above information is useful to you.

Yours truly, 

Trial Transparency Team

Clinical Sciences and Operations

Sanofi

Fascinating news, thank you for bringing this to us! 

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thethinker82

@Star33hcs Well, it's easy to find the information that HSV529 provides some cross-protection against HSV-1 although its main target is HSV-2.  Regarding the G103 vaccine candidate it looks that its primary focus is HSV-2. Well, this may change during the NCT04222985 (and further) trial when more results are avaiable.

A very interesting but complex article about G103 is avaiable here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322202

Finally it should be noted that most current HSV vaccine candidates are meant for prophylactic application. So they should prevent an infection with HSV 1 and 2. As we already now, regarding the Herpes simplex virus, this is hard to achieve but nevertheless clearly less difficult then the development of a therapeutic HSV vaccine.

I know that's hard for Herpes sufferers, but before we will see a therapeutic HSV vaccine there will exist a prophylactic one.

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VHS_bl

Is anybody planning to participate in this? Also has this been affected by Covid-19?

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shadowgirl88
On 1/14/2020 at 11:38 PM, StayingUpbeat said:

A new, rather complex, therapeutic vaccine clinical trial is now recruiting: https://clinicaltrials.gov/ct2/show/NCT04222985.  Finding details of the actual formulations of the 4 vaccines being tested has been (at least for me) unfruitful.  This is however, definitely the output of the Sanofi Pasteur HSV-529 vaccine collaboration with Immune Design.

For those that haven't been following the story...

What eventually became HSV-529 started as a development effort by Harvard Virologist David Knipe and the NIH.  It was licensed for continued commercial development by a small biotech named Acambis (who named it ACAM-529).

In 2008 Acambis was acquired by Sanofi Pasteur (the 8th largest pharmaceutical company in the world) at a price of $546M and the vaccine was renamed HSV-529.

In 2013 Sanofi kicked-off a Phase I clinical trial of the HSV-529 vaccine at the NIH in Maryland. On a personal note I participated in this clinical trial.  The trial yielded reasonably good results but doesn't appear to be the home run Sanofi was hoping for.

In what can only be described as a massive step backwards; in 2014 Sanofi divested the HSV-529 vaccine to a small biotech named Immune Design in what was ostensibly characterized as a "collaboration".  It was an odd decision in many respects not the least of which being that Immune Design already had a protein subunit HSV vaccine candidate named G103 in their pipeline. https://www.sanofi.com/en/media-room/press-releases/2014/2014-10-16-07-00-00

The divestment was almost certainly a result of the firing of Sanofi's outspoken CEO Christopher Viehbacher who championed acquisition of Acambis (the company that originally began development of the HSV-529 vaccine).  He even took the bold step of relocating his primary office to the newly acquired company's Massachusetts location.  It's rumored these decisions combined with a couple poorly performing financial quarters sealed his fate (and unfortunately the fate of the HSV-529 vaccine as well)

As if this story couldn't get any stranger Immune Design was acquired in February of 2019 by Sanofi competitor Merck (the 3rd largest pharmaceutical company in the world) to the tune of $300M.

The currently recruiting clinical trial still lists "Immune Design" and "Sanofi Pasteur" as the clinical trial sponsors.  I'm not sure if that is simply an artifact of when the Clinical Trial submission paperwork was filed or the clinical trial sponsors will be updated to Sanofi Pasteur & Merck but this is clearly the result of the HSV-529 "collaboration".

More importantly, and equally unclear, is what is actually in the 4 formulations of this clinical trial.  Is it the HSV-529 vaccine? Immune Design's G103 vaccine? Both in different dose levels?

If participating in the trial it's the first thing I would ask but, given the companies involved, this is still likely the best HSV vaccine clinical trial that is going to occur in 2020.

I just wrote a post about this! I was wondering if anyone had any information about this! I was reading it on the clinical trials webpage. Is there anyone here who is participating?  I seen it was being held in N.C....not too far from me. Unfortunately I don’t have the time to be involved. Wish I could though. I really pray this brings forth good results!

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thethinker82

I would like to participate, but this NCT04222985 trial is US-only and I am located in Europe... ;)

Whatever, I probably couldn't take part anyway because the trial lists under inclusion criteria also the point "HSV-2 seropositive confirmed by Western blot".

So this means most likely that HSV-2 seronegative people cannot participate. This is not listed in that form under the "exclusion" section. It is clearly written that "healthy volunteers" are accepted. Well, in my view this contradicts somewhat with the "HSV-2 seropostive" inclusion criteria.

Maybe I will write a second email to the Sanofi Transparency Team and ask if there are really only "HSV-2 seropostive healthy individuals" accepted...

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shadowgirl88
15 hours ago, thethinker82 said:

I would like to participate, but this NCT04222985 trial is US-only and I am located in Europe... ;)

Whatever, I probably couldn't take part anyway because the trial lists under inclusion criteria also the point "HSV-2 seropositive confirmed by Western blot".

So this means most likely that HSV-2 seronegative people cannot participate. This is not listed in that form under the "exclusion" section. It is clearly written that "healthy volunteers" are accepted. Well, in my view this contradicts somewhat with the "HSV-2 seropostive" inclusion criteria.

Maybe I will write a second email to the Sanofi Transparency Team and ask if there are really only "HSV-2 seropostive healthy individuals" accepted...

I’m Ghsv2 positive. It sucks. I pray this works!!!!!!

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shadowgirl88
On 2/17/2020 at 10:48 PM, StayingUpbeat said:

I am not. Though I did find out (after the HSV-529 Phase I trial was complete) that I received the vaccine and not the placebo.

With the exception that my prodrome to an outbreak now includes a fever I haven't noticed any symptomatic difference.

Do you think the fever is from your body’s T-cell response to the virus?

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Bob9932

I will try to participate in this trial as I’m close to one of the locations. 

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thethinker82
Posted (edited)

Great, - I would also participate if I could...

Maybe you will get the trivalent vaccine G103;) Some claim that it is superior to HSV-529.

If G103 is so good like the hyped "Perelman" trivalent HSV vaccine (University of Pennsylvania) then it could really outperform most other HSV vaccine candidates.

Whatever, it will be really interesting to see how this trial develops and what the feedback is. A pity that this trial is US only.

Edited by thethinker82

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themotion
On 4/24/2020 at 10:52 AM, thethinker82 said:

@Star33hcs Well, it's easy to find the information that HSV529 provides some cross-protection against HSV-1 although its main target is HSV-2.  Regarding the G103 vaccine candidate it looks that its primary focus is HSV-2. Well, this may change during the NCT04222985 (and further) trial when more results are avaiable.

A very interesting but complex article about G103 is avaiable here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6322202

Finally it should be noted that most current HSV vaccine candidates are meant for prophylactic application. So they should prevent an infection with HSV 1 and 2. As we already now, regarding the Herpes simplex virus, this is hard to achieve but nevertheless clearly less difficult then the development of a therapeutic HSV vaccine.

I know that's hard for Herpes sufferers, but before we will see a therapeutic HSV vaccine there will exist a prophylactic one.

@Cas9 Hey, Sorry to bother you, but can you share your opinion on the content quoted above. Hope all is well.

 

Thank you

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Runner278
On 8/11/2020 at 7:45 AM, themotion said:

@Cas9 Hey, Sorry to bother you, but can you share your opinion on the content quoted above. Hope all is well.

 

Thank you

Yes, please do. This doesn’t make any sense. Most of the trials that are active or will be soon are for a therapeutic vaccine. I’m sure the drug companies would love to have the prophylactic first as there is a ton of money in that, but I just don’t see this happening. 

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