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Introduction
The Staphypan Staphylococcus toxoid vaccine treatment for ME/CFS, discovered by Professor Carl-Gerhard Gottfries in Sweden, is arguably one of the most effective ME/CFS treatment ever devised, allowing many sick ME/CFS patients to return to work. This treatment was used by Prof Gottfries to treat ME/CFS in Sweden as early as the 1960s.
Unfortunately the Staphypan vaccine was discontinued by the manufacturer Berna Biotech in 2005, because its manufacturing process did not comply with new good manufacturing practice (GMP) regulations. No replacement vaccine was found, leaving many Swedish ME/CFS patients who had greatly benefited from regular monthly injections of the Staphypan vaccine to relapse back into ill health.
Prof Gottfries himself regularly administers Staphypan to keep his own ME/CFS at bay, and he stockpiled a lifetime's supply of this vaccine before it ceased manufacturing, as did some other ME/CFS patients in Sweden. But for new ME/CFS patients, this effective treatment became unavailable after 2005.
In 2015, after Google-searching the world in multiple different languages, I came across a similar Staphylococcus toxoid vaccine, manufactured in Russia by pharmaceutical company Medgamal. I informed Prof Gottfries about this Russian vaccine, and subsequently both Gottfries and myself tested it out on ourselves. Prof Gottfries told me that he found the Russian vaccine worked to prevent his ME/CFS from returning, but he found the Russian vaccine not quite as effective as the original Staphypan that he continues to use.
When I tried the Russian vaccine myself, it put me into near remission from my moderate ME/CFS. This vaccine banished my brain fog, and gave me incredible mental clarity and mental energy. The mental clarity was so good that my mind was sharper than it was even when I was healthy. As a result, I was able to perform complex computer programming tasks that brain fog would normally prevent me from doing.
Unfortunately in my case, after 3 weeks of enjoying near full remission, the Russian vaccine completely stopped working for me, even though I continued to inject it regularly.
But as far as I am aware, the Russian vaccine continued to work for Prof Gottfries, although I believe he eventually switched back to the more effective Staphypan vaccine.
Later, Medgamal also discontinued their vaccine, because they needed to update and modernise their vaccine production process. So for some years, the Medgamal vaccine became unavailable.
But the Medgamal Staphylococcus toxoid vaccine has just now become available again.
Where to Buy the Russian Vaccine
At the moment, the only Russian pharmacy serving the international market which offers this vaccine is https://extrapharmacy.ru. They charge $115 for a box of 10 x 1.0 ml ampoules of the Russian vaccine.
Note however that this Medgamal Staphylococcus vaccine is not listed on Extra Pharmacy's website; to buy it, you must contact the pharmacy through their Telegram chat at @russianmeds, or via their email given here.
Important point: Medgamal make two types of Staphylococcus toxoid vaccine, and it is vital to get the right one. For treating ME/CFS, the adsorbed version of the Staphylococcus vaccine is required. This adsorbed Staphylococcus vaccine is shown here on the Medgamal website. The adsorbed vaccine contains an adjuvant which boosts the effect of the vaccine.
The non-adsorbed version of the vaccine does not have an adjuvant and is weaker, so may be ineffective for ME/CFS purposes (I tried the non-adsorbed vaccine, and it did not have any effect). The non-adsorbed vaccine is shown here on the Medgamal site.
In the Russian language, the adsorbed vaccine is called Анатоксин Стафилококковый Очищенный Адсорбированный (translation: Staphylococcal Anatoxin Purified Adsorbed), and it looks like this:
Russian Staphylococcus toxoid adsorbed vaccine
Russian Staphylococcus toxoid adsorbed vaccine: the box containing 10 x 1 ml ampoules
Russian Staphylococcus toxoid adsorbed vaccine: one of the 1 ml ampoules
The slightly milky colour of the vaccine seen above is a good sign, because that milky colour can be lost in vaccines which have been damaged due to freezing.
Thermostability of Vaccines
Note that these Staphylococcus vaccines should be stored in a refrigerator (but make sure they do not freeze). But it should be fine to ship them at ambient temperature, because toxoid vaccines are the most thermostable of all vaccines. Page 12 of this document states that for adsorbed diphtheria and tetanus toxoid vaccines, there was:
- A 50% decline in potency after 4 to 8 days at 53–55°C
- A 50% decline in potency after 80 to 90 days at 45°C
- A 50% decline in potency after 10 to 13 months at 35–37°C
- A 50% decline in potency after 5 to 7 years at 20–25°C
How to Inject the Staphylococcus Vaccine
The original Staphypan Staphylococcus vaccine was injected subcutaneously once every 3 to 4 weeks to maintain its benefits. The belly area is usually a good place for subcutaneous injections. But when this vaccine is first started, Prof Gottfries in his 2002 clinical trial slowly titrated up the dose according to the follow scheme:
Gottfries's protocol: Doses for Staphypan vaccine injection in the introductory first eight weeks:
- Week 1: one injection of 0.1 ml of vaccine
- Week 2: one injection of 0.2 ml of vaccine
- Week 3: one injection of 0.3 ml of vaccine
- Week 4: one injection of 0.4 ml of vaccine
- Week 5: one injection of 0.6 ml of vaccine
- Week 6: one injection of 0.8 ml of vaccine
- Week 7: one injection of 0.9 ml of vaccine
- Week 8: one injection of 1.0 ml of vaccine
During the up-titration process, it not uncommon to have local reactions at the site of injection, where the skin will turn a little red for a few days after the injection.
Prof Gottfries says that if the local reaction is larger than the size of "a child's hand palm" (a child's palm is around 6 cm across), then in his clinic, they would not increase the vaccine dose at the next injection the following week, but would keep at the same dose level for two weeks in a row.
Anecdotal reports suggest the first manifestations of improvement appear after around 2 weeks taking the vaccine, with the full benefits taking 3 or 4 months to manifest. Reference: this post.
Titration Using Bacteriostatic Water Method
The following details a method I devised myself to help reduce the number of vaccine ampoules used in the introductory first 8 weeks of titrating up the vaccine doses.
In principle, you would use eight ampoules of the Russian vaccine in the introductory first 8 weeks, because even though you only use a fraction of the ampoule for each injection (for example, on the first week you only inject 0.1 ml out of the 1 ml in the ampoule), you have to throw away the rest of the ampoule after breaking it open, because it loses sterility.
But in order not to be so wasteful, what I did was buy a 10 ml bottle of Hospira bacteriostatic water, and I added one 1 ml ampoule of the vaccine into that bottle. Hospira bacteriostatic water contains a preservative which keeps the bottle contents sterile for around 28 days after first using the bottle (especially if stored in the fridge).
Then using a sterile needle and syringe, I just draw out from this bottle of bacteriostatic water/vaccine mixture the appropriate dose for each week of the first 4 introductory weeks (drawing out 1.1 ml of the mixture gives me 0.1 ml of vaccine, drawing out 2.2 ml of mixture gives me 0.2 ml of vaccine, etc). That way I make one ampoule last for the first 4 weeks of the introductory protocol, and can thus save on 3 ampoules.
So using my bacteriostatic water method, you only need 5 ampoules of vaccine to cover the introductory 8 week up-titration protocol.
How to Perform a Subcutaneous Injection
To open a vaccine ampoule, you snap it open by the dot on the neck, as shown in this video. Then you draw the liquid contents into your syringe by placing the needle into the ampoule and pulling up the syringe plunger. Don't touch the needle with your fingers, as it will lose its sterility.
To give yourself a subcutaneous injection, see the instructions in this article. Basically, pinch up some belly skin into a mound, and subcutaneously inject into the mound of skin. The belly area is a good location, 1 or 2 inches left or right of the belly button.
For injection, I used thin 30 gauge needles (outer diameter 0.3 mm) which are ½ inch long, and 2 ml plastic syringes.
It is usually a good idea to inject a 1 ml volume of liquid slowly over a period of 60 seconds or so.
How Often Should the Russian Vaccine Be Injected?
When the Russian Staphylococcus toxoid vaccine was working for me, I found the benefits kicked in 3 days after each 1 ml injection. The benefits I experienced were incredible mental clarity, with amazing amounts of mental energy and motivation, which made me super-productive. The mental clarity was so good that my mind was sharper than it was even when I was healthy. I was suddenly able to perform intricate computer programming tasks, which I would not normally be able to do,.
Then on around day 8 after each injection, the benefits would begin to fade, and by day 10, they were almost gone. Thus I would re-inject another 1 ml of the Russian vaccine every 10 days, in order to maintain the benefits.
If you are injecting once every 10 days, this means that a box of 10 x 1 ml ampoules should last 100 days.
In the case of the original Staphypan Staphylococcus toxoid vaccine, Prof Gottfries noted its benefits would last 3 to 4 weeks in his ME/CFS patients before re-injection was necessary. So it seems the Russian vaccine is a little weaker, wearing off more quickly, and thus requires more frequent injections. At least that is what I found.
Instruction Leaflet for the Russian Adsorbed Staphylococcus Vaccine
Original Russian Medgamal Adsorbed Staphylococcus Vaccine Instructions in Russian here.
ChatGPT translation of these instructions into English here:
Instructions for Use:
The preparation is a uniform white suspension with a yellowish tint, which separates upon standing into a clear supernatant liquid and a soft, loose sediment that fully disperses when shaken.
Each 1.0 ml of the preparation contains:
Donor selection and plasmapheresis procedures must comply with the “Medical Examination Guidelines for Donors”, approved by the Russian Ministry of Health on 16.11.1998.
STAPHYLOCOCCAL TOXOID PURIFIED ADSORBED
Dosage Form
Suspension for subcutaneous administration.Description
Staphylococcal toxoid purified adsorbed is a staphylococcal toxin that has been detoxified with formalin and heat, purified from ballast proteins, and adsorbed onto aluminum hydroxide gel.The preparation is a uniform white suspension with a yellowish tint, which separates upon standing into a clear supernatant liquid and a soft, loose sediment that fully disperses when shaken.
Each 1.0 ml of the preparation contains:
- Staphylococcal toxoid: 10 EU (2 doses)
- Aluminum (sorbent): 0.9–1.3 mg
- Thiomersal (preservative): 80–120 mcg
Pharmacotherapeutic Group
Immunobiological medicinal product (IBMP).Immunological Properties
When administered, the preparation induces the production of specific antibodies against staphylococcal exotoxin.Indications for Use
- Prevention of staphylococcal infections in individuals at high risk, such as industrial and agricultural workers frequently exposed to injuries.
- Immunization of patients scheduled for planned surgeries.
- Immunization of donors to obtain anti-staphylococcal plasma and immunoglobulin.
Contraindications
The use of staphylococcal toxoid purified adsorbed is contraindicated in:- Acute infectious and non-infectious diseases, or exacerbations of chronic diseases (the vaccine may be administered no earlier than one month after recovery or remission).
- Chronic diseases in the decompensation stage.
- Severe allergic reactions to food, drugs, or other substances.
- Thymomegaly.
- Blood diseases.
- Malignant neoplasms.
Administration and Dosage
- The preparation is administered deep subcutaneously in the lower angle of the scapula.
- The ampoule must be thoroughly shaken before opening to obtain a homogeneous suspension.
- The vaccine should not be used if the ampoule has damaged integrity, improper labeling, physical property changes (e.g., presence of insoluble flakes), expired shelf life, or improper storage conditions.
- The opening of ampoules and the immunization procedure must be carried out under strict aseptic and antiseptic conditions.
- Single dose: 0.5 ml.
- The vaccine must not be stored in an open ampoule.
Immunization Courses
- Industrial and agricultural workers: Two injections (1 dose each) with an interval of 30 to 45 days. First revaccination occurs 3 months after completing the course. Subsequent revaccinations occur annually.
- Patients scheduled for surgery (children over 1 year and adults): Two injections (1 dose each) with an interval of 20 to 30 days. The second injection should be administered no later than 4-5 days before surgery.
- Donors: Three injections at 7-day intervals:
- First injection: 1.0 ml (2 doses)
- Second injection: 1.0 ml (2 doses)
- Third injection: 2.0 ml (4 doses)
- Total for full course: 4.0 ml (8 doses)
Donor selection and plasmapheresis procedures must comply with the “Medical Examination Guidelines for Donors”, approved by the Russian Ministry of Health on 16.11.1998.
Adverse Effects
- General reactions: Mild malaise and low-grade fever (up to 37.5°C) for 24–48 hours.
- Local reactions: Redness and formation of a small infiltrate (≤5 mm) at the injection site.
- Redness disappears within 3-4 days.
- Infiltrate may persist for up to 10 days, and in some cases, over 30 days as a painless thickening.
- If an infiltrate is present, the next injection should be given on the opposite side.
Interactions with Other Medications
The vaccine should be administered at least 3 weeks after a previous injection of human immunoglobulin or anti-staphylococcal plasma.Packaging
Ampoules of 1.0 ml (2 doses). The package includes 10 ampoules, an instruction leaflet, and an ampoule knife.Transportation
According to SP 3.3.2.1248-03, at temperatures between 2°C and 8°C. Freezing is not allowed.Storage Conditions
According to SP 3.3.2.1248-03, at temperatures between 2°C and 8°C, in a dry, light-protected place. Freezing is not allowed.Prescription Status
For use in medical and preventive institutions only.Shelf Life
2 years. Expired vaccine must not be used.Manufacturer
Medgamal Branch, N.F. Gamaleya Research Institute of Epidemiology and Microbiology, Russian Academy of Medical Sciences, Russia.Prof Gottfries's Studies on the Staphylococcus Vaccine for ME/CFS
These are the studies that Prof Gottfries conducted:
• A 1998 clinical trial on 28 female patients with both ME/CFS and fibromyalgia found 50% of patients were able to resume half-time or full-time work as a result of the vaccine treatment. The study noted that the vaccine treatment continued to work for these patients after 2 to 6 years.
• In a 2002 clinical trial on 100 female patients with both ME/CFS and fibromyalgia, it was found 65% of patients responding favourably to the Staphylococcus toxoid vaccine, with 33% of obtaining a 50% reduction in symptoms.
• A 2004 study looked at the long-term outcome of the Staphylococcus vaccine treatment for ME/CFS. It noted a high level of safety over 5 years of continuous use of the vaccine. The study points out the beneficial effects of the vaccine last 3 to 4 weeks before re-injection is required.
• The 2004 Zachrisson study looked at the antibodies in the blood generated by the Staphypan vaccine. The vaccine induced IgG antibodies to several Staphylococcus toxins and cell wall components. The strongest IgG antibody response was directed at alpha toxin, and to a lesser extent lipase. A correlation was observed between the strength of the antibody response to alpha toxin and lipase, and the degree of clinical improvement in the patients. The study found that the main antigenic components of Staphypan are: alpha toxin, enterotoxin A, enterotoxin B, toxic shock syndrome toxin 1, cell wall antigens, lipase.
Vaccine Mechanism of Action
Professor Carl-Gerhard Gottfries says he does not know the mechanism by which the Staphylococcus toxoid vaccine works to improve ME/CFS. But we know from the 2004 Zachrisson study that for patients given the vaccine, the higher the level of antibodies to alpha toxin induced by the vaccine, the greater the clinical improvement obtained by the patient. So this suggests that the vaccine might ameliorate ME/CFS by neutralising Staphylococcus alpha toxin.
If we look at what alpha toxin does in the body, we see that:
- Alpha toxin is a strong Th17 and IL-17 inducer. Ref: 1 Now elevated Th17 is linked to viral persistence, and may promote viral replication in acute coxsackievirus B myocarditis. So alpha toxin may promote viral persistence.
- Alpha toxin activates the cellular receptor ADAM10. Ref: 1 ADAM10 is involved in several aspects of immune regulation, and ADAM10 activation may promote T-cell exhaustion, which makes it harder to clear viruses. So alpha toxin may hamper viral clearance.
- Alpha toxin increases CD8 T-cell deactivation, so weakens antiviral T-cell responses. Ref: 1
- Russian researchers in this 2001 paper show how Staphylococcus alpha toxoid from the Russian Medgamal vaccine can correct the immune deficiency caused by coxsackievirus B infection.
- Interestingly, Staphylococcus toxoid vaccine was used as a diabetes treatment as early as the 1930s, as detailed in this 1936 study (type 1 diabetes is linked to coxsackievirus B4 infection).
History of the Staphylococcus Vaccine Treatment
In around 1961 Professor Carl-Gerhard Gottfries discovered by serendipity that the Staphypan Staphylococcus vaccine was effective for his own ME/CFS. He developed ME/CFS during the Asian flu H2N2 pandemic in 1957 and 1958. He was hit with ME/CFS right at the very beginning of his medical career as a psychiatrist, but used the Staphypan vaccine to treat himself, and this allowed him to go back to work. Gottfries also started using the vaccine to treat ME/CFS patients referred to his psychiatric unit.
Unfortunately his boss at the psychiatric unit did not like all these ME/CFS patients coming to the clinic, and asked Gottfries to stop seeing these patients. So Gottfries had to stop treating ME/CFS, but kept taking the vaccine himself to keep his ME/CFS at bay.
Decades later as Prof Gottfries approached retirement, he felt that he should do some research on this vaccine, and so in 1998 he set up up an ME/CFS clinic (the Gottfries Clinic) in Sweden with the purpose of treating patients with the vaccine as well as conducting research on the vaccine — research which included the two double-blinded clinical trials detailed above.
This info comes from this video: Interview with Professor Carl-Gerhard Gottfries, Part 1.
Further Information
- This post provides a weblink index to the most informative comments in the original Staphylococcus vaccine thread on Phoenix Rising.
- Carl-Gerhard Gottfries: A Swedish Chronic Fatigue Syndrome Vaccine Treatment Success Story
- Carl-Gerhard Gottfries — MEpedia
- Interview with Professor Carl-Gerhard Gottfries, Part 1: Background and Vaccine
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Hypothesis