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Staph vaccine to treat CFS??

Hip

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if the effect was a product of the destruction of b-lymphocytes
I wouldn't think there is much destruction of B cells (or any other cells) by the Staphypan vaccine, because I presume the alpha toxin and other Staphylococcus toxins in Staphypan would have been formaldehyde-deactivated.

Prof Gottfries points out that the Staphypan vaccine has a superantigen effect in the body (which weakens the adaptive immune response by overloading it), and he thinks that may be how this vaccine works for ME/CFS.

High levels of lipase, alpha toxin, enterotoxin B, toxic shock syndrome toxin 1 (TSST-1), and cell wall antigens were found in the Staphypan vaccine in a 2002 study by Zachrisson et al. Ref: 1

Note that enterotoxin B and TSST-1 are potent superantigens.
 
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More evidence suggesting a correlation between Staphylococcus aureus carriage and superantigen production when dealing with symptoms of CFS and other chronic diseases.

Bacteria may cause type 2 diabetes

http://www.sciencedaily.com/releases/2015/06/150601172848.htm
Chronic exposure to a toxin made by Staphylococcus aureus (staph) bacteria produces the hallmark symptoms of Type 2 diabetes (T2D), including insulin resistance and glucose intolerance, in rabbits, new research shows. The findings suggest that eliminating staph bacteria or neutralizing the toxins might have potential for preventing or treating T2D.
The team's latest study, published recently in the journal mBio, shows that superantigens interact with fat cells and the immune system to cause chronic systemic inflammation, and this inflammation leads to insulin resistance and other symptoms characteristic of Type 2 diabetes. In examining the levels of staph colonization on the skin of four patients with diabetes, Schlievert's team estimate that exposure to the bacterial superantigens for people who are heavily colonized by staph is proportional to the doses of superantigen that caused the rabbits to develop diabetes symptoms in the team's experiments.

Chronic Fatigue Syndrome A Toolkit for Providers

http://www.cdc.gov/cfs/pdf/cfs-toolkit.pdf
People with CFS also are more likely to have obesity, insulin resistance, metabolic syndrome, irritable bowel disease, non-melancholic depression, fibromyalgia, chemical-sensitivity disorder;
 

Hip

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More evidence suggesting a correlation between Staphylococcus aureus carriage and superantigen production when dealing with symptoms of CFS and other chronic diseases.

http://www.sciencedaily.com/releases/2015/06/150601172848.htm
A link between a Staphylococcus aureus toxin and abnormal glucose tolerance in rabbits (suggestive of type 2 diabetes) probably says little about a possible connection between Staphylococcus infection and ME/CFS. I don't think this is evidence of any link between Staphylococcus and ME/CFS. Though it is certainly interesting research as far as the etiology of type II diabetes is concerned.

The Staphylococcus toxin in question is toxic shock syndrome toxin-1 (TSST-1) — see the study here. This is one of the toxins found in the Staphypan vaccine.



There has been some speculation about the role of coagulase negative Staphylococcus and ME/CFS. If you search this forum, or search the web, you will find a few details. You might consider starting a thread on coagulase negative Staphylococcus if it interest you.

But I would doubt that the benefits of this vaccine relate to Staphylococcus infection. Nearly all of the patients that Prof Gottfries originally treated using this vaccine developed ME/CFS from the 1957 Asian flu virus (H2N2).
 
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Hip

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ATTENTION: Russian Staphylococcus toxoid vaccine

I may have found an international Russian pharmacy willing to ship the Russian Staphylococcus vaccine by courier in a cold pack / ice pack (to keep the vaccine below 8ºC in transit). The cost for one box of 10 x Staphylococcus vaccine ampoules will be $72, plus $65 for 7-day courier delivery using a cold pack.

Russian Staphylococcus adsorbed vaccine
1 box of 10 ampoules
anatoksin-stafilokokkovyiy.png

Instructions for use here

The price for the same box in local Russian pharmacies is around $20 to $25, so their packing and shipping costs are a little high. But perhaps if enough of us are interested in buying a box of this vaccine, I may be able to negotiate a lower cost. I am currently talking to this pharmacy.

The Staphylococcus vaccine must be injected subcutaneously, but this is easy to do (there are lots of YouTube instructional videos explaining how). Note that subcutaneous injections are much easier than intramuscular or intravenous infections.

For treating ME/CFS, Prof Gottfries administers 1 x Staphypan® Staphylococcus vaccine each month. I am not sure how strong the Russian Staphylococcus vaccine is in comparison to the Staphypan® vaccine. But assuming each ampoule of the Russian vaccine is equivalent to the Staphypan® vaccine, then this box of 10 ampoules will represent 10 month's supply.



Note that this Russian product may be a slightly different formulation to Staphypan®, and as such, is a product not previously tested on ME/CFS patients. Thus there is an inherent risk to taking this Russian vaccine, and anyone doing so needs to understand that this is an experimental treatment, which may not work, and may have significant risks or side effects.
 
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Russian Staphylococcus vaccine
1 box of 10 ampoules
View attachment 13810
Instructions for use here
Could I just make the point that this looks like a dubious product Hip. Vaccines are normally injected into sites that produce a high immune response - intradermal or intramuscular, not subcutaneous. The subcutaneous space is pretty inert immunologically, except in terms of adverse local reactions to some of the biologic drugs. I would strongly suspect that this product does nothing at all. It also mentions non-infectious disease as a contraindication and warns about risk of anaphylaxis. I would personally strongly advise against trying it out.
 
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Hi Hip, I am certainly very interested in purchasing a box. I am in Australia and keen to facilitate postage to here if possible. I guess we need to be confident we are getting the equivalent product.
Thanks.
 

Hip

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Could I just make the point that this looks like a dubious product Hip. Vaccines are normally injected into sites that produce a high immune response - intradermal or intramuscular, not subcutaneous. The subcutaneous space is pretty inert immunologically, except in terms of adverse local reactions to some of the biologic drugs. I would strongly suspect that this product does nothing at all. It also mentions non-infectious disease as a contraindication and warns about risk of anaphylaxis. I would personally strongly advise against trying it out.
Thanks for your points and advice. It had crossed my mind also that this might be an ineffectual product, which I may be wasting my money on.

I am however more concerned with the possible side effects such as anaphylaxis that you point out. I don't have any history of severe allergy; just some hay fever in the past, and no sign of increased allergy from ME/CFS. But needless to say, I will test with extremely minute vaccine doses initially.

That is very interest about the subcutaneous areas being pretty immunologically inert. The Russian vaccine instructions specify that the vaccine should be administered subcutaneously under the shoulder blade; I am not sure why they chose this particular area. Perhaps it has slightly more immunologically responsiveness?

It should be noted though that the Staphypan® Staphylococcus toxoid vaccine that Prof Gottfries used to treat his ME/CFS patients is injected subcutaneously — it mentions this in one of his studies:
The patients were on immunotherapy by a staphylococcus vaccine administered subcutaneously in a dose of 1 mL every 3rd to 4th week.

Though the question in my mind is whether this Russian Staphylococcus toxoid vaccine is similar enough to the Staphypan® vaccine that Gottfries showed had considerable efficacy for ME/CFS. Some research by Gottfries's team found that Staphypan® contains:
High levels of lipase, alpha toxin, enterotoxin B, toxic shock syndrome toxin 1 (TSST-1) and cell wall antigens.
Ref: 1
The Russian vaccine contains formaldehyde-deactivated alpha toxin, but it is unclear what other toxoids might be included in the vaccine. Thus just how similar the Russian vaccine is to Staphypan®, it's hard to say.
 
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The Bulletin of IACFS/ME, Volume 17, Issue 4 - Winter 2009-10. "Immunotherapy of Fibromyalgia and Chronic Fatigue Syndrome by a Staphylococcus Toxoid Vaccine"

I read most of this thread a few weeks ago, and I don't think I've seen this 2009 paper posted yet but apologies if this is a repeat posting.

Just to highlight two points in response to recent posts above. Firstly, in the Staphypan trial the vaccine was injected subcutaneously in gradually increasing dosages. Secondly, it is not clear that any of the suggested alternative products contain the same or equivalent biological materials, or what mix of the components in the Staphypan vaccine is responsible for it's therapeutic effect in CFS. The Staphypan vaccine includes both coagulase positive and negative strains of staphylococci along with a toxoid.

"The patients received weekly subcutaneous injections in increasing dosages of the vaccine during the initial 8-10 week period, and thereafter once a month. A positive clinical effect was recorded in 65 % of patients on active treatment according to global ratings. The items fatigability, reduced sleep, failing memory, concentration difficulties, hostile feelings and sadness improved significantly more in the active group compared to the placebo group. During a two-month controlled and blind withdrawal period, however, most responders relapsed and they were therefore offered maintenance treatment."
"The vaccine used, Staphypan, is composed of a mixture of staphylococcus strains and a toxoid. The preparation includes extracts of Staphylococcus aureus and Staphylococcus epidermidis. Staphypan also contains the preservative thiomersal, which is a double-salt including salicylate and ethyl-mercury. Staphypan was developed by Berna Biotech Ltd., Switzerland in the 1950s, but has since 2005 been withdrawn from the market. The withdrawal was not due to any problems with the use of the vaccine but was explained by costly need of modernizing the manufacturing processes and of low sale."
 

Hip

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Thanks for your points, @hinterland.
Firstly, in the Staphypan trial the vaccine was injected subcutaneously in gradually increasing dosages.
The patients received weekly subcutaneous injections in increasing dosages of the vaccine during the initial 8-10 week period, and thereafter once a month.
In the instructions for the Russian Staphylococcus vaccine manufactured by Medgamal (Медгамал) in Moscow, they also say that the vaccine must be administered in gradually increasing dosages:
A full course of treatment includes 7 injections administered once every 2 days, with the following increasing doses: 0.1 - 0.3 - 0.5 - 0.7 - 0.9 - 1.2 - 1.5 ml.
If I try out the Russian vaccine, I will start with even smaller doses initially, say 0.025 ml or even less, in order to minimize any adverse effects, should they arise. And rather than take the Russian vaccine every two days as its instructions state, I will space out these doses more, taking one dose say every week.



Secondly, it is not clear that any of the suggested alternative products contain the same or equivalent biological materials, or what mix of the components in the Staphypan vaccine is responsible for it's therapeutic effect in CFS. The Staphypan vaccine includes both coagulase positive and negative strains of staphylococci along with a toxoid.
It certainly is a gamble trying the Russian vaccine, and it may not work at all, for the reasons you give.

The main components of the Staphypan® vaccine are:

Alpha toxin
Enterotoxin A
Enterotoxin B
Toxic shock syndrome toxin 1 (TSST-1)
Cell wall antigens
Lipase

Table 2 of the Olaf Zachrisson 2004 Study
Table 2 Olaf Zachrisson Study .png

These ingredients were determined by Zachrisson et al, 2004. See:
Immune modulation with a staphylococcal preparation in fibromyalgia/chronic fatigue syndrome: relation between antibody levels and clinical improve.

Full paper here.



Enterotoxin B seems to have significant connection to autoimmune disease:
Possible Role of Staphylococcal Enterotoxin B in the Pathogenesis of Autoimmune Diseases

Enterotoxin B plays a critical role in the pathogenesis of autoimmune disorders either by initiating the autoimmune process or by inducing a relapse in an individual in clinical remission from an autoimmune disorder. Enterotoxin B can directly activate T lymphocytes, leading to the release of cytokines, superoxides, or other mediators of inflammation either directly or indirectly, because of its unique ability to cross-link human major histocompatibility complex (MHC) class II and T cell receptors (TCR), forming a trimolecular complex.
So in terms of the mechanism behind the major improvements in ME/CFS provided by Staphypan®, enterotoxin B may play the central role, if we consider ME/CFS as an autoimmune condition.

The way enterotoxin B modulates autoimmunity may involve its effects on the CD28 receptor.

It has recently been discovered that enterotoxin B binds to the CD28 receptor (refs: here and here), and this receptor has been linked to autoimmune disease (CD28 controls differentiation of regulatory T-cells, which play a central role in maintaining immune self-tolerance).

Interestingly enough, the CD28 receptor super-agonist drug TGN1412 is being tested as a treatment for autoimmune diseases. But TGN1412 was also the drug in the 2006 Northwick Park Hospital London clinical trial disaster, in which several young men became very ill with organ failure. So activating the CD28 too much can be very dangerous. After this clinical trial disaster, this TGN1412 drug is now making a comeback, using doses 10 to 20 times less (and being renamed as TAB08).


As for Staphylococcus enterotoxin A, this had two distinct binding sites for major histocompatibility complex (MHC) class II molecules (ref: here).
 
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Hip

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Note that because this Russian Staphylococcus vaccine may be a slightly different formulation to Staphypan®, and because this Russian vaccine, as far as I am aware, has not been previously tested on ME/CFS patients, there may be some risk to taking it.

Thus I am not advising or encouraging anyone to take this vaccine.
 
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That is very interest about the subcutaneous areas being pretty immunologically inert. The Russian vaccine instructions specify that the vaccine should be administered subcutaneously under the shoulder blade; I am not sure why they chose this particular area. Perhaps it has slightly more immunologically responsiveness?
The only references to vaccines ever being given under the shoulder blade (presumably meaning lower down than the shoulder blade in a standing individual) I can find on the internet are for giving vaccines to Russian soldiers and for vaccinating cats. Worryingly, vaccination of cats between the shoulder blades has been associated with aggressive malignant tumours at the site. I guess the Russians probably vaccinate soldiers there so that they can do it quickly without them having to roll their sleeves up. It does not fill me with confidence !
 

M Paine

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@Hip, may I ask if you are still going to try this vaccine?

Does anyone know what this Russian vaccine is called exactly? Is this 'Staphylovac'? I notice there is new mention of Staphylovac-2 in recent literature.

I think the Russian's deserve some credit, in that they continued to develop alternative measures against microbes after the development of penicillin. Russian phage therapy can effectively cure people with terminal antibiotic-resistant infection. I'm sure that the Russians would have much to offer, were they more integrated with Western society.

Just a reminder, the CDC considers aluminium hydroxide safe for use in humans, for those who may be worried reading the comments referring to feline vaccination-associated sarcomas.
 

Hip

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@Hip, may I ask if you are still going to try this vaccine?
Very likely. I am in contact with three Russian/Ukrainian online pharmacies, trying to see if they can supply and ship the vaccine in a cold pack to me.

As mentioned earlier, one pharmacy said they can do this, but there is an issue: I don't think a cold pack will be able to maintain the required refrigerated temperature (between 2ºC and 8ºC) for more than a couple of days; but the courier they use takes 7 days. That means that during transit, my vaccine will probably be sitting at room temperature for around 5 days, which potentially may destroy or degrade the vaccine. I am unclear on how long refrigerated vaccines can survive out of the fridge at room temperature.

I did find one article in which pharmaceutical company GSK said that their flu vaccine Fluarix will be fine if it spends 3 days out of the fridge at room temperature:
GSK said: "The following information, based on in-house testing, can be used to help make a decision in cases of temperature variation above the recommended storage conditions. The maximum time that Flurarix can be stored at controlled room temperature (20 - 25ºC) is 72 hours. When stored in this manner, the vaccine will maintain its full licensed shelf life if returned to refrigerated storage at 2 - 8ºC."
And this study found that a 2 week exposure to room temperature did not affect the shelf life of an influenza vaccine.

So it may be that my Staphylococcus vaccine can survive 5 days at room temperature while in transit. But the thing is, if I take this vaccine and it does not help improve ME/CFS, I will always be wondering whether the vaccine was degraded in transit.

I guess I could ask if the pharmacy has a faster courier, but their 7-day courier and cold pack service already costs $65.

The other thing I am looking into is booking a fast 2-day courier myself, which could hopefully pick up the vaccine from the pharmacy's premises in Russia, and deliver to the UK.



Does anyone know what this Russian vaccine is called exactly?
I could not find any brand name; but the manufacturer's name is Medgamal, NIIEM (or in Russian: Медгамал, НИИЭМ).



I think the Russian's deserve some credit, in that they continued to develop alternative measures against microbes after the development of penicillin.
My understanding is that before the antibiotic era, such vaccines were a common way to fight bacteria infections.

This is in fact why Prof Gottfries, who developed ME/CFS from the 1957/58 Asian flu viral epidemic, started experimentally trying out these bacterial vaccines. The 1950s were just before the antibiotic era got into full swing, and these vaccines were still commonplace even in Europe and Sweden (so he said in his video interview).
 
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Hip

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Is this 'Staphylovac'? I notice there is new mention of Staphylovac-2 in recent literature.
Staphylovac-2 appears to be a different Russian Staphylococcus vaccine. I cannot find anywhere that sells it, but in a 2014 study on Staphylovac-2, they mention this vaccine is made by SPA Microgen (Микроген in Russian). SPA Microgen is a large state-owned company producing immunobiological products.

However, on the website of SPA Microgen, there is no sign of this Staphylovac vaccine, not under their vaccine product list, nor their toxoid product list.
 

msf

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Prof. Edwards, I have to call foul on the shoulder vaccinations causing cancer in cats remark. What happened to ´you can prove anything with an animal model?´ The only justification I can see for paying attention to an animal model in this situation and not in others is that this is a negative decision rather than a positive one.

Hip, you would have thought that Prof. Gottfries would know about this source, if it was the same, or a similar, vaccine. Why don´t you contact him and bring it to his attention before you inject yourself?
 
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msf

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Oh, I agree with Prof. Edwards that it might not be a good idea to inject yourself with anything Russian soldiers are injected with, though.
 
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Hip

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Hip, you would have thought that Prof. Gottfries would know about this source, if it was the same, or a similar, vaccine. Why don´t you contact him and bring it to his attention before you inject yourself?
@Theodore has already contacted Prof Gottfries to inform him of this Russian source. I have had some communication in the past with Prof Gottfries (talking about the possible mechanism of action by which the Staphypan® vaccine treats ME/CFS); but I plan to inform him myself of the existence of this Russian Staphylococcus vaccine shortly.

Everything I do is at ME/CFS speed: that is to say, slowly.
 
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Hip

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shoulder vaccinations causing cancer in cats
Even before Prof Edwards made this remark, I decided that I would probably administer the Russian Staphylococcus vaccine subcutaneous in the belly area, which is the area I use for all the drugs I inject in my various experiments