Staph vaccine to treat CFS??

[Tinnybell]

On Tuesday I gave myself another rabbit vaccine injection of 0.1 ml dosage. This time I am not getting all those side effects. I think it had a effect on fatigue comparable to the medgamal vaccine. I also think that It does not improve the mood the same way the medgamal vaccine does.

It is possible that these negative effects are because I am increasing my doses of the vaccine too fast, and taking the doses too quickly. Perhaps I should wait a week between doses, rather than 3 days between doses.

When I think of it, maybe this is the case with the rabbit vaccine.

 

[Hip]

I also think that It does not improve the mood the same way the medgamal vaccine does.

I found the same thing with the АСП Staphylococcus vaccine for dogs based on enterotoxins A, B and C: this does not improve mood. Whereas the Medgamal Staphylococcus vaccine based on alpha toxin has a noticeable mood boosting, antidepressant effect.

I am now injecting the Medgamal Staphylococcus vaccine every few weeks, especially when I have depression. I have neurologically-caused depression alongside my ME/CFS symptoms, and I find this depression is hard treat. So it is useful to have an effective and fast-acting antidepressant treatment such as Medgamal Staphylococcus vaccine.

 

[hvac14400]

0.1 ml? that's like a mosquito bite - it's just nothing. i can't feel anything from it, let alone any sides.

btw - am almost totally recovered from 2ml of non-adsorbed shyt
stll scared a.f. to pin myself again

but will do 1ml tomorrow. coz here is cold now - around 0 deg C, so the autumn epidemic season is starting and i need a lil immunity boost, to go through it easily

are you planning going full dose with this rabbit stuff any soon? like you did with medgamal.

 

[Tinnybell]

0.1 ml? that's like a mosquito bite - it's just nothing. i can't feel anything from it, let alone any sides.

btw - am almost totally recovered from 2ml of non-adsorbed shyt
stll scared a.f. to pin myself again

but will do 1ml tomorrow. coz here is cold now - around 0 deg C, so the autumn epidemic season is starting and i need a lil immunity boost, to go through it easily

are you planning going full dose with this rabbit stuff any soon? like you did with medgamal.

I think not all vaccine are equal. Maybe the rabbit vaccine is just more potent than the others and 0.2ml had a big effect on me. So I think I will try 0.15ml next time. I am a careful person.

Also this shit is painful to inject as if it burns my flesh, at the dosage I am using it's fine but I think say 1ml the pain would be very awful.

I now plan to inject myself with the rabbit vaccine and medgamal vaccine on alternating weeks. It feels wasteful to throw out a bottle of rabbit vaccine having only used a fraction of it but it is not really a big deal in terms of money. I just don't feel like having it sitting in the fridge opened for too long.

 

[hvac14400]

yea, i remember that burning feeling, while injecting non-adsorbed version + antifagin, but it was pretty tolerable up to 1ml of each of them anyway. and my pain tolerance is pretty low.

is there any instruction that you can google translate? i wonder how long you can store used bottle, if at all.

interestingly - it's been almost full 4 weeks since i injected 2ml of non-adsorbed version and i steel didn't feel any anxiety whatsoever, not even slightest bit of it. but when injecting even 3ml of adsorbed stuff, its effect starts fading away at the end of the week 3 and after week 4 there was clearly feeling that something is not right already.
but right now i feel great, despite being very sick for previous 4 weeks straight.

and am currently on 19-th bottle of human growth hormone - every morning injection, just a tiny 1ME a day, maybe that changed something, idk.

 

[Hip]

@Tinnybell did you get my PM a few days ago about the the АСП Staphylococcus vaccine for dogs?

 

[hvac14400]

anybody here knows their igf-1 serum levels? am ended up being deficient, so injecting 1iu of human growth hormone everyday returned me back to normal (for my age) - now am like 50% less prone to pems and recovering from them at a much faster rate.
this improvement is much stronger and more noticeable than from staph vacc, so go check your level too.
just in case : )

 

[swede]

@Ninan

Do you know much about the history of using Staphylococcus toxoid vaccine to treat ME/CFS? Was this treatment mainly done in Sweden, and mainly done under the monitoring of Professor Gottfries? Or did it also occur in other countries, and by other researchers? I have certainly not heard of it being available in the UK.

And what happened to all the ME/CFS patients in Sweden who were taking Staphylococcus toxoid vaccine, and became healthy enough to go back to work, when the vaccine was withdrawn, as a result of the Swedish FDA ban, due to its mercury preservative?

We became sick .. again ...

 

[helperofearth123]

A new Staphylococcus toxoid vaccine is already being developed at the University of California, San Diego. The researchers their placed Staphylococcus alpha-hemolysin toxin into "nanosponges" in order to make this new vaccine.

And the University of Iowa has developed a new Staphylococcus toxoid vaccine that may be available for sale within a year. Their vaccine however is slightly different to the above two in that it contains three Staphylococcus toxins: toxic shock syndrome toxin (TSST), Staphylococcus enterotoxins, and alpha hemolysin toxin. See here.

And the University of Minnesota has fully developed a Staphylococcus toxoid vaccine manufacturing technology, which is just waiting to be adopted by a vaccine manufacturer (the University's technology transfer department is currently looking to license this manufacturing technology) — though I think this may be the same vaccine as the one developed at the University of Iowa.


When any of these vaccines become available, it will be a great boon for ME/CFS patients.

What happened with this?

 

[Jesse2233]

@Hip would you consider sending the Russian vaccine to Gottfries so he can assess its similarities to the one he used?

 

[Hip]

@Hip would you consider sending the Russian vaccine to Gottfries so he can assess its similarities to the one he used?

Prof Gottfries has tried both versions of the Medgamal Russian Staphylococcus toxoid vaccine, and says that the adsorbed version of the vaccine appears much stronger and better than the non-adsorbed version. He told me that he feels the absorbed version may be similar to the original Staphypan, and is currently giving this absorbed version a 4 month test. I will contact him again at the end of the 4 months, to ask him about his findings.

Myself and 4 others on this thread who tried the Russian Staphylococcus toxoid vaccine found it had a noticeable mood boosting effect, and for me it also a noticeable motivation boosting effect; but it did not seem to help our ME/CFS symptoms. However, we were unfortunately using the weaker non-adsorbed version of the Medgamal Russian Staphylococcus toxoid vaccine. So this may explain why we had poor results in terms of ameliorating ME/CFS.

The stronger vaccine is the absorbed version, which contains an aluminum adjuvant. Prof Gottfries has found that this stronger absorbed vaccine causes a slight worsening of ME/CFS symptoms in the first week after vaccination (the vaccine is given once every 3 or 4 week), and he said Staphypan also often causes this slight worsening in the first week.

Both versions can be bought from rupharma.com, which is a reliable pharmacy: adsorbed version; non-adsorbed version.

I am myself going to start testing the absorbed version soon.

 

[Jesse2233]

Very interesting @Hip, can't wait to hear your results on the absorbed version.

Do you have the impression that if Gottfries had the funding he could still produce the original formulation?

 

[Jesse2233]

We became sick .. again ...

What was your experience like using the vaccine?

 

[Hip]

Do you have the impression that if Gottfries had the funding he could still produce the original formulation?

I think if any pharmaceutical company were interested developing a treatment for ME/CFS, they could probably create a replacement of Staphypan that works for ME/CFS, although I think it would take $millions in development costs to do this, because you would have to create a brand new vaccine.

Staphypan was made using old artisanal methods, and it appears these could not be updated to comply with modern GMP standards (Good Manufacturing Practice standards).


I wrote to Janssen Pharmaceuticals in May 2016, who are the company that bought out Berna Biotech, the original manufacturer of Staphypan. I asked Janssen whether they had any interest in creating a new up-to-date formulation of the vaccine.

Janssen's answer to me was that on two separate occasions in the past, technicians had seriously examined how the Staphypan vaccine, which was manufactured using old artisanal processes, could be updated to comply with GMP standards.

Janssen told me that the first occasion was back in the days of Berna Biotech, when Professor Gottfries's protests to Berna regarding the vaccine discontinuation were taken seriously, and several teams in Berna made a substantial effort in trying to figure out how to update production to comply with the GMP standards, but without success.

Janssen told me that the second occasion was when Berna Biotech were bought out by Crucell, where they once again looked into the possibility of updating Staphypan, but the conclusion was that GMP compliant production of Staphypan seemed technically impossible, and so unfortunately was finally abandoned.



My email to Janssen is given below (click the button to view):

Spoiler: My email to Janssen Pharmaceuticals

My Email to Janssen Pharmaceuticals:

Dear Sir

Are you aware that Janssen already has, within its drugs portfolio, a pharmaceutical product capable of effectively treating myalgic encephalomyelitis, a highly disabling neurological/immunological disease that leaves many patients housebound or bedbound and unable to work for decades, with around 17 million patients worldwide?

In clinical trials performed in 1998 and 2002, Professor Carl-Gerhard Gottfries in Sweden demonstrated that one of your prior products called Staphypan, a Staphylococcus toxoid vaccine manufactured by Berna Biotech in Switzerland (Berna Biotech was bought out by Crucell, who then merged with Janssen), proved to be a very effective treatment for myalgic encephalomyelitis (also called chronic fatigue syndrome, and usually abbreviated to ME/CFS).

Professor Gottfries found that Staphypan led to major improvements in around one-third of ME/CFS patients (improvements so significant that it would often allow patients to go back to work), and another third of patients experienced useful improvements. In a disease for which there are currently almost no pharmaceutical treatments, Gottfries's findings were a major discovery. Staphypan has very low side effects in ME/CFS patients, and is easily administered by subcutaneous injection. Gottfries discovered it requires one Staphypan injection every 3 to 4 weeks to keep the ME/CFS symptoms under control. This vaccine treatment has shown long-term viability: it keeps ME/CFS symptoms at bay even after decades of use. Professor Gottfries discovered this vaccine treatment for ME/CFS in the early 1960s, and he talks about his discovery in this video.

Professor Gottfries had been successfully treating thousands of ME/CFS patients with Staphypan in his ME/CFS clinic in Sweden for 18 years. But unfortunately, soon after Professor Gottfries's two clinical trials on the vaccine were published, Berna Biotech in 2005 discontinued Staphypan production. Berna Biotech faced the prospect of paying nearly $1 million in order to modernize the manufacturing process of Staphypan, so as to meet new EU and US pharmaceutical regulations for vaccine production. Berna Biotech concluded that with such an expense, it was not economically viable to continue making Staphypan. Professor Gottfries and his team in Sweden protested loudly to Berna Biotech, explaining that Staphypan was a very effective ME/CFS treatment; but Berna did not heed this, and went ahead and discontinued the production of Staphypan.

I am writing because I presume Janssen are in possession of all the original Staphypan manufacturing know-how from Berna Biotech, and would thus be in a position to reintroduce Staphypan if there were a good business model for doing so. As far as I can see, the ME/CFS business model would be excellent, given that Staphypan will be highly effective for around one-third of the 17 million ME/CFS patients globally, and be a useful treatment for another third of these patients. The two-thirds of ME/CFS patients who respond to Staphypan will need to take it every three or four weeks for the rest of their life, but this fact only adds to the business model for reintroducing Staphypan.

The Staphypan vaccine could even be further developed, improved and then patented as an ME/CFS treatment. Analysis of Staphypan showed it contains the Staphylococcus toxoids alpha toxin, enterotoxin B, TSST-1, as well as Staphylococcus cell wall parts. It is not known which of these components provide the beneficial effects for ME/CFS, but it has recently been discovered that enterotoxin B binds to the CD28 receptor, and this receptor modulates autoimmune disease (and the rituximab trials have indicated that ME/CFS may well be an autoimmune condition).

It is very unfortunate that an effective pharmaceutical like Staphypan was not further pursued as an ME/CFS treatment, and is now no longer available. ME/CFS is a very serious chronic disease that often lasts a lifetime, and which has been somewhat neglected by medical researchers and pharmaceutical companies alike. But with Staphypan, here is an opportunity to actually do something positive for ME/CFS.

I'd much appreciate your thoughts and feedback on this.

Best regards

 

[Helen]

modernize the manufacturing process of Staphypan, so as to meet new EU and US pharmaceutical regulations for vaccine production

I was told that it was tiomersal (mercury as a preservative) in the vaccine that had to be exchanged to a non toxic substance, if not being banned. What you wrote might have included this, or do you know if there were more in the manufactoring process that had to be changed?

 

[nandixon]

In the 2015 study below, it was found that Staphylococcus aureus apparently achieves its commensal ability with its human host due to unique anti-inflammatory TLR2 ligands in the bacterial cell wall, whose effect occurs through activation of the Akt/mTOR (mTORC1) pathway.

So with respect to the seemingly favorable effect of the Staphypan vaccine in ME/CFS, it may be that the ingredient (see @Hip's post here) in that vaccine most likely to be helpful, ironically, is the one least likely to have been suspected, i.e., the bacteria's intact cell wall.

The study may, possibly, also be indicating that a patient with lower IL-10 levels might be more responsive to the Staphypan vaccine than a patient with higher IL-10 levels.(?)

If the anti-inflammatory TLR2 ligands could be identified and even structurally modified, they might be a very effective drug-based treatment for ME/CFS (assuming the studies with Staphypan are actually good, of course).

Uncoupling of Pro- and Anti-Inflammatory Properties of Staphylococcus aureus

Our results suggest the presence of anti-inflammatory TLR2 ligands in the staphylococcal cell wall, whose identification may provide templates for novel immunomodulatory drugs.
...
We show that the human anti-inflammatory response to these S. aureus isolates is mediated by the phosphoinositol 3-kinase (PI3K)-Akt-mTOR and extracellular signal-regulated kinase (ERK) pathways and does not require internalization of S. aureus, whereas the proinflammatory response utilizes the p38 pathway and is dependent on phagocytosis of this microbe.
...
We have previously shown that the IL-10 response to S. aureus is primarily initiated by TLR2 engagement (21).
...
Together, these findings show that the pro- and anti-inflammatory TLR2 ligands are largely restricted to the staphylococcal cell wall.
...
Together, these results show that the PI3K-Akt-mTOR pathway is differentially activated by nasal S. aureus isolates, regulating the anti-inflammatory but not the proinflammatory response to this microbe.
...
Together, these findings point to structural differences in pro- and anti-inflammatory TLR2 ligands. The molecular nature of these ligands is unknown at the moment, although it may be diverse and present in other microbial species (e.g., polysaccharide A in Bacillus fragilis [25]).

Note that there are many different ligands that activate TLR2. Most of these are not likely to have the positive effect of the "good" ligands in the staphylococcal cell wall.

Also note that the "bad" ligands found in the staphylococcal cell wall do not come into play with the Staphypan vaccine because the bacteria must undergo phagocytosis for that to happen.

This study may give further support for an under-activated Akt/mTORC1 pathway as being an important mediator of the disease in ME/CFS (although not the underlying cause, of course), which the recent Fluge & Mella study would suggest.

 

[Jesse2233]

Thanks @Hip, if it would cost millions, then what did the $900k figure refer to? I could potentially raise that if Gottfries could produce a vaccine

Millions is another story

 

[Hip]

I was told that it was tiomersal (mercury as a preservative) in the vaccine that had to be exchanged to a non toxic substance, if not being banned. What you wrote might have included this, or do you know if there were more in the manufactoring process that had to be changed?

The email I got back from Janssen Pharmaceuticals did not go into any details about what was required to update the old Staphypan vaccine to modern GMP standards.

I was going to put a copy of this Janssen email online, but then I read in the small print at the bottom that the email is confidential, and intended only for the individual named in the e-mail address. But the email did not say much, just what I already detailed above.

The person in Janssen Infectious Diseases & Vaccines, Belgium who kindly replied to my email said he had to contact one of Janssen's vaccine regulatory directors in their Bern facility, in order to get the background history on Staphypan (since these events took place 12 years ago). He then just relayed to me what he had learnt from the regulatory director in Bern.

I know nothing about vaccine production, but from what they said in the email, it does not sound quite as simple as just replacing mercury with some other preservative, because I was told in the email that more than one team looked at the issues of trying to update the manufacturing process of Staphypan, but in spite of their efforts, could not find a way to do it. So its sounds as if the problem of updating the Staphypan vaccine was quite complex. Nothing about mercury was mentioned in the Janssen email.

Thanks @Hip, if it would cost millions, then what did the $900k figure refer to? I could potentially raise that if Gottfries could produce a vaccine

I just threw in a rough ballpark figure when I said "millions". One would have to speak to a vaccine development expert to get a precise figure.

The $900,000 that the Gottfries Clinic people wanted to raise, mentioned in this earlier post, probably relates to a now defunct project by the Gottfries Clinic team to produce a Staphypan replacement, via a company they set up called Gefrix Therapeutics AB.

The following comes from a Swedish Blog (Google translated to English):

Gottfries and Gothenburg University searched anyway patent on the combination of vaccine and B12 : "... a staphylococcal preparation is Administered ... with vitamin B12 and / or folacin ... first 8-10 times During a period of 4-12 weeks When The dose Increased ice ... then Approximately once a week for 5-15 weeks, and finally Approximately once a month for a period of 1-10 years. " The clinic had about 250 patients on this experimental treatment as the Swiss company Berna in 2005 stopped producing Staphypan.

The people around Gottfries Clinic then formed a company for the new production of the vaccine. They had big plans. " Gefrix Therapeutics AB is an emerging pharmaceutical company committed to immunomodulation in the treatment of Chronic Fatigue Syndrome and Fibromyalgia. ... Developing a novel, well-tolerated and clinically Effective treatment ... in collaboration with The Gottfries Clinic, a specialist clinic at The Sahlgrenska University Hospital, Gothenburg, Sweden. ... Current plans for the launch of the product in the EU and in the USA allows for a regulatory exclusivity period in the EU and in the USA expiring in 2020. " Gefrix dissolved in 2012.

 

[Hip]

Staphylococcus aureus apparently achieves its commensal ability with its human host due to unique anti-inflammatory TLR2 ligands in the bacterial cell wall, whose effect occurs through activation of the Akt/mTOR (mTORC1) pathway.

So with respect to the seemingly favorable effect of the Staphypan vaccine in ME/CFS, it may be that the ingredient (see @Hip's post here) in that vaccine most likely to be helpful, ironically, is the one least likely to have been suspected, i.e., the bacteria's intact cell wall.

That's most interesting. I just found this paper, which proposes that TLR-2 may be a "crossroads between infections and autoimmunity". And this review, which says that TLR-2 and TLR-4 play a pivotal role in the pathogenesis of autoimmune diseases.

So an effect on the TLR-2 receptor may be another way in which the ingredients of the original Staphypan vaccine (in this case the Staphylococcus bacterial cell wall ingredient) have an immunomodulatory effect, potentially explaining how Staphypan ameliorates ME/CFS.

(I am trying to follow your mTOR discussions, but am not yet clued up enough on this area to comment; I'll have to do some background reading first).



A Russian Staphylococcus bacterial cell wall part vaccine (called a Staphylococcus antifagin vaccine) is available for anyone who want to try it: see this post.

I got hold of this Russian Staphylococcus antifagin vaccine a few months ago (rupharma.com very kindly sourced me one box, although it's not one of their standard items for sale), and I have been trying it for the last two months.

I have not noticed very much from the Staphylococcus antifagin vaccine, in terms of effects on my ME/CFS symptoms, except that on two occasions, when I took a 1.0 ml dose of the Staphylococcus antifagin vaccine, I felt a welcome increase my normally flat emotional responses for two days after the vaccine injection, with a pleasant and robust emotional tone present in my mind (normally, ME/CFS robs me of nearly all emotional tone or emotional expression, flat emotions of course being a symptom of ME/CFS). So that seemed promising.

On one of these two occasions, the vaccine also made me tired and mentally slow thinking for a couple of days after, but I did not mind too much, because of the pleasant emotional tone present in those two days.

 

[Jesse2233]

That's unfortunate on Gerfix

Is there a way to get in touch with a decision maker at Janssen to take another look at replicating the vaccine? Their ROI as a treatment for CFS/ME could be substantial