Staph vaccine to treat CFS??

[nandixon]

@Hip, The bacterial cell walls may have to come from the Staphylococcus aureus species, unfortunately. In the study, they noticed significant differences even among different isolates:

We found up to a 3-fold difference in the IL-10 production in response to these nasal S. aureus isolates by PBMCs (Fig. 1A). This response was reproducible and consistent for multiple PBMC donors and was largely determined by the bacterial isolate.

 

[Hip]

Is there a way to get in touch with a decision maker at Janssen to take another look at replicating the vaccine?

The person who replied to my email was Dr Henri Deckx, Director of Global Clinical Development, Janssen Infectious Diseases & Vaccines, Belgium. That sounds like he is an important decision maker (although he is not on this page of the Janssen Infectious Diseases & Vaccines Leaders).

He did say in the email to me that:

The case was seriously reconsidered in the early days when Crucell took over BB, but the conclusion was that GMP production of Staphypan seemed technically impossible, and then finally and definitely abandoned.

The underlining is mine. BB = Berna Biotech.

 

[Hip]

@Hip, The bacterial cell walls may have to come from the Staphylococcus aureus species, unfortunately.

It does not say anywhere in the Staphylococcus antifagin vaccine instructions which species of Staphylococcus the vaccine contains.

The other option is to get hold of the Staphage Lysate dog vaccine discussed in this thread, which Dr Ritchie Shoemaker uses/used for ME/CFS (although on the website, it does not seem to state which Staphylococcus species are in that either).

 

[Jesse2233]

It does not say anywhere in the Staphylococcus antifagin vaccine instructions which species of Staphylococcus the vaccine contains.

The other option is to get hold of the Staphage Lysate dog vaccine discussed in this thread, which Dr Ritchie Shoemaker uses/used for ME/CFS (although on the website, it does not seem to state which Staphylococcus species are in that either).

Do we have info on Shoemaker's success rate vs that of Gottfries?

And any new developments with the various university studies?

 

[nandixon]

It does not say anywhere in the Staphylococcus antifagin vaccine instructions which species of Staphylococcus the vaccine contains.

Sorry, I mistook "antifagin" for the species name. I'm guessing it probably is the aureus species then. So the question is instead, does it contain the entire cell wall (as opposed to just fragments or other components)?

 

[nandixon]

Also, I realized I might not have made clear earlier, that the reason the entire cell wall (which Staphypan contains) is necessary, is because of the finding in the study I referenced several posts above, that:

We observed that the IL-10 and TNF-α responses were almost exclusively induced by the staphylococcal cell wall (Fig. 2A and andB).B). Moreover, culture supernatants of S. aureus, which contain the secreted toxins and shedded components of the staphylococcal cell wall, minimally induced IL-10 and TNF-α production by PBMCs (<10% of the response to heat-killed S. aureus) (Fig. 2C and andD).D). Together, these findings show that the pro- and anti-inflammatory TLR2 ligands are largely restricted to the staphylococcal cell wall.

 

[Hip]

Do we have info on Shoemaker's success rate vs that of Gottfries?

I couldn't find any info online, but I imagine Staphage Lysate must have provided more of a minor amelioration to ME/CFS patients, rather than anything major, as if were major, I am sure we would have heard more about it.

And any new developments with the various university studies?

You mean the two new Staphylococcus vaccines under development, detailed in this post? Well, the University of Iowa vaccine, although ready to roll, has been put on hold indefinitely, because like Staphypan, it contains Staphylococcus enterotoxin B as a toxoid (toxoid = disabled toxin), which rather ludicrously has been classed as a potential bioterrorism agent by the CDC, and so restricted.

(I tried a Russian Staphylococcus dog vaccine containing enterotoxins A, B and C for six weeks, see this post. I did not really notice much benefit in that period.)


The University of California San Diego vaccine has no bioterrorism issues, but I have not heard much in the way of updates from it, apart from this paper on the vaccine published in March 2016.

 

[Hip]

the reason the entire cell wall (which Staphypan contains) is necessary, is because of the finding in the study I referenced in several posts above

This makes me think that perhaps the specific artisanal methods used to make the original Staphypan vaccine might be important for its ability to ameliorate ME/CFS. One could imagine that even if a new replacement Staphypan vaccine were developed, based on modern GMP standards, it might not work as well, due to some differences in processing the bacterial cell wall. That's if the bacteria cell wall is playing a major role in modulating ME/CFS, though.

Alternatively, it may just be that one or more of the toxoids present in Staphypan are playing the major role in modulating ME/CFS. In which case, I should imagine that the manufacturing process wouldn't matter so much, as a toxoid is a toxoid.

 

[Jesse2233]

The person who replied to my email was Dr Henri Deckx, Director of Global Clinical Development, Janssen Infectious Diseases & Vaccines, Belgium. That sounds like he is an important decision maker (although he is not on this page of the Janssen Infectious Diseases & Vaccines Leaders).

The case was seriously reconsidered in the early days when Crucell took over BB, but the conclusion was that GMP production of Staphypan seemed technically impossible, and then finally and definitely abandoned.

@Hip is it possible that BB's formula for the original vaccine could be licensed by Janssen to a manufacturer in a country with less strict GMP?

 

[Hip]

@Hip is it possible that BB's formula for the original vaccine could be licensed by Janssen to a manufacturer in a country with less strict GMP?

That's an interesting thought.

Looking at this GMP Practice in the Pharmaceutical Industry document, it says that: "compliance with GMP is a necessary condition for marketing authorization".

So you may be able to make a non-GMP compliant pharmaceutical, but I am guessing you won't be able to sell it in Western or developed nations that stipulate GMP compliance.

 

[swede]

What was your experience like using the vaccine?

Very good ,got the vaccine during 5 years, so it was good, It is worth trying get it back on the market, it is own by American company today ,what prevents Them to produce this vaccine ? I will ask

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

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

 

[swede]

No since they own recipe , it won't cost that much, but they bought Berna biotech so they could "Cover up" this kind of treatment with toxoid vaccines.

 

[Helen]

Thanks @Hip for your reply and for your great work researching this vaccine.

No treatment, to my knowledge, has changed the lives of so many PWME as much as this vaccine did, and still does for some. The story that Prof. Gottfries has told about himself, and how he has been able to live a full life thanks to it, for about 60 years !! is just one of the witnesses.

I had an appointment with Prof. Gottfries at his clinic four years ago, and he was the first to diagnose me with ME. I asked if I had been a candidate for the vaccine if it still had been available. I should have been, so this vaccine is a "stone in my shoe" for many reasons.

I´ve been excited about it since I first heard of it by a patient who still takes it. She was lucky to get enough ampoules of the vaccine for the rest of her life before the company closed down the production.

@swede , thanks for your information. So sorry to hear that you had to stop the treatment. Looking forward to hearing more about what you know about the actual situation as of the vaccine.

 

[Hip]

Very good ,got the vaccine during 5 years, so it was good,

Swede, can I ask, on the ME/CFS scale of mild, moderate and severe, where were you on this scale before you took the vaccine, and where did you move up to on the scale after taking the vaccine?

The mild, moderate, severe levels are probably most easily understood in terms of what activities you are able to perform:

Those with mild ME/CFS may be working full or part time, but struggle to do so.

Those with moderate ME/CFS are generally not able to work, probably don't leave the house much, have to do domestic chores slowly with breaks and rests, and may need 1 or 2 hour's naps in the middle of day.

Those with severe ME/CFS tend to be fully housebound or bedbound, and find domestic chores like cooking or any form of housework very difficult or impossible.

 

[swede]

I had lot of abscesses since 1984 so when Í started wit this vaccine I was completely gone I had a low body temperature, freezing could not sit because of all those toxins going around in my body. So My infection was big. Normally Staph Epidermidis do not give boils, but when they arises in our body they mutade and becomes even more toxic, and S.Aureus occur.

It was produced to treat a staff infection (Mostly hospital bacteria) back in the 50`s in "IN VIVO" I was bedbound because of this toxins. I do not remember how fast I got well, but I did very healthy, a lot of energy but each third week I felt that I needed the injection, ( That was different some got it once a month) I do not remember how long time it took before My boils disappeared, but if if I had them I was not affected. The toxoid vaccines only neutralize the toxin in my blood.And since Staph Epidermidis is not treatable (MRSE) are there no other solutions. But because of this enterotoxin B we get autoimmune diseases, enterotoxin and enterovirus , has something in common. I believe that can be a possible cause, of a lot of autoimmune disease.

So it is worth fighting for otherwise I will end up with ALS, they will never admit it is polio

 

[Hip]

I was bedbound because of this toxins. I do not remember how fast I got well, but I did very healthy, a lot of energy but each third week I felt that I needed the injection, ( That was different some got it once a month) I do not remember how long time it took before My boils disappeared, but if if I had them I was not affected.

So you were bedbound with ME/CFS fatigue, but your illness also involved a Staphylococcus epidermidis infection causing boils? And the Staphypan brought you back to full health?

 

[swede]

So you were bedbound with ME/CFS fatigue, but your illness also involved a Staphylococcus epidermidis infection causing boils? And the Staphypan brought you back to full health?

Iam diagnosed with CFS/ME despite the fact that I had boils. As I understand, S. Epidermis normally do not produce boils, but that do S.Auerus. One Culture is made and that showed S.Epidermidis and they said its just normal .Yes I felt healthy. Prof Gottfries and his team suspect that this is one big cause of CFS/ME .. was one the phone whit Berna Biothec and they confirmed it, but it should not been given to a newborn before age of 3 because the immune system is not fully developed.

 

[Jesse2233]

That's an interesting thought.

Looking at this GMP Practice in the Pharmaceutical Industry document, it says that: "compliance with GMP is a necessary condition for marketing authorization".

So you may be able to make a non-GMP compliant pharmaceutical, but I am guessing you won't be able to sell it in Western or developed nations that stipulate GMP compliance.

@Hip

I wonder if that Russian manufacturer that is currently supplying the Staph vaccines you bought could be convinced to make a formulation based on BB's blend with the proper investment and demonstrated market

 

[swede]

I do belive The company who own Staphypan today has obligations to produce it... You know The human rights and so on, I believe there is miljon out there, i will try to Contact this firm I saw in previous link who to contact ,but i did not find there email addresses . But first I will check with Swiss agencies, who actually owns it , because it was whit drawn in 2001, has gone some Year since The yankees bought it, But for knowledge Staphypan is produced after a Canadian prescription from 1935 I will find the paper I do not think You will find it in internet , but it is worth going to Library,

 

[nandixon]

But for knowledge Staphypan is produced after a Canadian prescription from 1935 I will find the paper I do not think You will find it in internet , but it is worth going to Library,

I've attached a pdf file for a 1935 study by C. E. Dolman entitled CLINICAL USES OF STAPHYLOCOCCUS TOXOID that may be describing the preparation of what became known as Staphypan.(?)

In these laboratories pooled toxins of high potency are obtained from selected staphylococcal strains by a method fully described elsewhere.[7] To the pooled sterile toxins, formalin is added to give from 0-1 per cent. to 0-15 percent. by weight of HCHO, and the mixture is incubated at 37 [degrees] C. for about 14 days.

Also attached is reference 7 from a 1934 study again by C.E. Doman entitled "Ingestion of Staphylococcus Exotoxin by Human Volunteers: With Special Reference to Staphylococcic Food Poisoning."