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Vitaherpavac- Russian Vaccine?

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fixme1
3 minutes ago, Mackie82 said:

Lower back, legs and extreme genital area pain due to peripheral nerve damage which is caused by herpes. I got fed in this forum since so many idiots are saying this is not herpes related some of them they don’t have genital herpes anyways this virus is dormant for decades for some people and for others they have monthly ob’s. So it’s tricky and affecting us deferently. Thanks 

I believe you Mackie 

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Miha

People who say its not even herpes, as well as the doctors and those alike who keep telling people that herpes is just a minor skin condition and no big deal are ignorant idiots.

Edited by Miha

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wildman

This is an older piece of research (published 1985), but it is interesting because it reports on the testing of a purified inactivated HSV2 protein extraction (native "subunit") in human subjects. No adjuvant was used, and the effect  was (unsurprisingly) not very durable (though the response would likely exceed that of inactivated HSV2 alone, were it to be tested on similar metrics). The report is interesting, particularly as various adjuvant technologies continue to advance, but as far as I know, this particular approach was not pursued much further, as research apparently went in other directions.

Link:

http://onlinelibrary.wiley.com/doi/10.1002/jmv.1890160206/full
"Clinical efficacy of a herpes simplex subunit vaccine," R. Cappel, S. Sprecher, F. De Cuyper, and J. De Braekeleer, Department of Virology, lnstitut Pasteur, Brussels, Belgium, Journal of Medical Virology 16:137-145 (1985)

There's a summary at the link above, but the bulk of the report might be behind a paywall - in any event, several of the more interesting sections are pasted below:

-------------------

"Abstract

A DNA-free herpes simplex type 2 subunit vaccine was administered to 18 volunteers without past evidence of herpes simplex type 1 (HSV 1) or herpes simplex type 2 (HSV 2) infection, to 44 patients with severe recurrent genital HSV 2 infection, and to 15 patients with severe oral type 1 HSV recurrences. The vaccine elicited both humoral and cell-mediated immunity in 97% of the subjects without past HSV infections and boosted significantly the cell-mediated immunity and antibody titers in almost all the patients with recurrent HSV 1 or HSV 2. The vaccine elicited particularly the production of complement-dependent cytotoxic antibodies in 96% of the patients with recurrent HSV 2 infections. This might, at least partly, explain the clinical efficacy of the vaccine. Indeed, we observed a significant decrease (t test, p < 0.01) in the attack rate of the recurrences and also a significant shortening of the time needed to complete healing of the lesions (t test, p < 0.01)."

"Vaccine:

The vaccine was prepared as described previously [Cappel, 1976; Cappel et al,1978; Cappel et al, 1980]. Briefly, purified HSV 2 grown on chick embryo fibroblasts was disrupted with a detergent (NP 40, Shell Co.). The envelope proteins were thereafter separated from the nucleocapsid by ultracentrifugation on a sucrose gradient. The vaccine contained nine polypeptides including the three major glycoproteins and, as shown previously by 3H-thymidine labelling, was free of DNA [Cappel et al, 1978; Cappel et al, 1980]."

"Subjects:

All the vaccinees were well informed volunteers; 18 had no serological evidence of past HSV 1 or HSV 2 infections, 15 had severe oral HSV 1 recurrences, and 62 had severe genital HSV 2 recurrences. The interval between the attacks in these latter patients ranged from 10-50 days (mean 35 days), as detailed in Table IV. The subjects of the different groups were matched for age and sex. The mean age was 31 +/- 9 years and 60% were males and 40% females. All the patients with recurrent HSV infections had been treated previously with IDU, levamisol, lysozyme, ZnSo4, and 34 had received several doses of inactivated HSV vaccines available in other countries. All the diagnoses were confirmed by viral isolation prior to the vaccination and during the recurrences. The strains were typed using monoclonal antibodies kindly provided by J. Lecomte (Institut Armand-Frappier, QuCbec, Canada).

Immunization Procedure:

The 18 subjects without past evidence of HSV infection, the 15 patients with recurrent HSV 1 infection, and 44 of the 62 patients with recurrent HSV 2 infection received 3 SC injections of 1.5 pg/kg of body weight of vaccine at a 2-week interval. The 18 remaining patients with genital HSV 2 recurrent infection received no vaccine and served as control group. We followed 20 out of the 44 vaccinees with HSV 2 genital infection and 10 out of the 15 with recurrent oral HSV 1 infection for 24 months. Since from the preliminary data it seemed that the booster effect induced by the vaccine declined after 6 months, these patients received three booster injections at 6-month intervals. Blood was collected before treatment and 2 weeks, 3 months, and 6 months after each injection."

"RESULTS

Antibody response:

Table I shows the humoral immune response in the 18 volunteers without past evidence of HSV infections. From this table it appears clearly that almost all the subjects developed the four types of antibody studied 6 weeks after the beginning of the vaccination. These antibodies appeared after the second injection of vaccine but peaked after the third injection. The neutralizing antibodies persisted for 6 months in about 65% of the subjects and then slowly declined. After 12 months only 30% of them had still detectable levels of these antibodies. As regards the complement dependent cytotoxic antibodies (CDCA), these appeared also after the third injection in 88% of the volunteers without past HSV infections. These antibodies declined more rapidly than the other antibodies studied, for 6 months after the vaccination only 38% of the subjects had still CDCA and 12 months later only two patients possessed still these antibodies.

The results observed after the first and second inoculation are not reported. Briefly, after the first injection none of the 18 subjects developed antibodies while after the second injection about 50% of them had developed the four types of antibody studied.

Table I also illustrates that for the 44 patients with recurrent genital HSV 2 infections, the vaccine increased significantly the titers of the NT, IF, and CF antibodies (t test, p < 0.01). This booster effect persisted for at least 6 months. The CDCA were also significantly boosted after the vaccination. Furthermore, the number of patients who possessed these antibodies after the immunization increased significantly (X2 = 9.1, p < 0.01). Indeed, before the vaccination only 21 possessed CDCA while 6 weeks later 42 (95 %) possessed CDCA. Six months after the vaccinations 33 (75 %) of the patients still possessed these antibodies with titers significantly higher as compared to those measured before the vaccination (X2 test, p < 0.01). The development and/or the increase of the titers of these various antibodies was probably not secondary to physiologic variations, because, as illustrated in Table I the antibody titers as well as the number of patients possessing these antibodies remained stable in the control group as well as in these patients during the 6 months prior to the vaccination. Furthermore, before the vaccination the antibody titers in both groups were similar suggesting again that the booster of the antibody titers was really related to the vaccination.

Cell-Mediated Immunity:

The results of the cell-mediated immunity (CMI) assessed in vitro by a lymphocyte transformation assay are summarized in Table III. None of the 18 subjects without past evidence of HSV 1 or HSV 2 infections responded to HSV antigens in vitro before the vaccination. Two weeks after the third injections (data shown in Table III), 16 (94%) responded not only to HSV 2 antigens but also to a lesser extent to HSV 1 antigens. This cross-reaction phenomenon is probably due to the fact that the vaccine contained the specific glycoproteins of HSV 2 but also common proteins. In this group of subjects the three injections of vaccine were needed to induce the CMI because after the first injection none of the subjects had developed CMI while after the second injection only 12 (60%) of the volunteers responded in vitro to HSV 2 antigens.

Among the patients presenting recurrent HSV 2 (44 patients) and HSV 1 (15 patients), respectively, only 32 (72%) and 7 (46%) responded to HSV 2 antigen in vitro, before the vaccination (Table II). After vaccination the level of reactivity of the lymphocytes to in vitro stimulation with HSV 2 antigens (envelope proteins or heat inactivated HSV 2) increased significantly in all the patients suffering from HSV 2 as well as in those with HSV 1 recurrences (t test, p < 0.01). Furthermore, after the vaccination the number of responding patients also increased significantly (X2 test, p < 0.01) since 42 (95%) of those with recurrent HSV 2 and 12 (80%) of those with recurrent HSV 1 responded to HSV 2 in vitro as compared to 32 (72%) and 7 (46%) before the vaccination, respectively. These data again clearly suggest that the vaccine was responsible for the increased CMI activity because in the control group the stimulation indexes as well as the number of responding patients remained stable. The data presented in Table III are those observed after three injections of vaccine because three injections were necessary to induce CMI in nonimmune subjects. In the patients with recurrent HSV 1 or HSV 2, the results observed after the second injection were similar to those shown in Table III after the third injection. The CMI elicited by the vaccine persisted at a stable level for 4-8 weeks and then slowly declined to prevaccination values after 3 months.

Clinical Efficacy:

The controls and the vaccinees were followed during 6 months before entering into the study. The three groups studied had similar attack rates, and the duration of the pain, although a little shorter for the patients with recurrent HSV 1, was not statistically different for the three groups (Table IV). The time to complete healing was also identical in the three groups before the vaccination.

Table IV illustrates the effect of the vaccine on the four parameters we studied. Although we must keep in mind that this study was not a double-blind, placebo controlled one, because the controls received no placebo, the data presented suggest nevertheless that the vaccination modified the course of the recurrences.

 Indeed, the interval between the attacks increased significantly in both groups of vaccinees (t test, p < 0.01) with a significant decrease consequently of the number of attacks. In addition, the duration of the pain and the time needed to complete healing of the lesions was reduced. In fact, the time to complete healing declined from 9 days to 4.8 days or 4.2 days for the patients with recurrent HSV 2 or HSV 1, respectively. These differences were statistically significant (t test, p < 0.01).

 We followed 20 of 44 patients with recurrent HSV 2 and 10 of 15 with recurrent HSV 1 for 24 months. Since the antibody titers declined after 6 months, these patients received booster injections at the 6-month interval. As can be observed in Table V, the number of recurrences in these patients remained low as compared to the controls or as compared to the attack rate before the vaccination. Conversely, the interval between the attacks increased significantly from 32 days to 87 or 93 days (t test, p < 0.01)."

 DISCUSSION

We have previously demonstrated that the vaccine used in the present study elicited body humoral and cell-mediated immunity in mice, rabbits, and chimpanzees [Cappel et al, 1978; Cappel et al, 1980; Cappel et al, 1982] as well as in humans [Cappel et al, 1980; Cappel et al, 1982]. These observations are also in agreement with others who found similar results after immunization with slightly different subunit vaccines, envelope proteins, or purified glycoproteins [Balachandra et al, 1982; Hilleman et al, 1981; Kitces et al, 1977; Klein et al, 1981; Skinner et al, 1982]. In the various animal models studied, we and others reported earlier that these vaccines protected the animals against experimental infection [Capel, 1976; Hilleman et al, 1981; Kitces et al, 1977]. In the present study we confirmed that the vaccine elicited the production of various types of specific antibodies as well as CMI in humans. Indeed, 16 out of 18 subjects without past evidence of HSV infections developed neutralizing antibodies, CF, IF, and complement-dependent cytotoxic antibodies while 17 of them developed specific CMI to HSV 2. Furthermore, in the patients suffering from recurrent HSV 2 or HSV 1 infections, the vaccine boosted considerably the antibody titers, particularly the CDCA but also boosted CMI. The CDCA that were elicited in almost all the patients with recurrent HSV infections after the vaccination, may play an important role in the control of the severity and/or frequency of the recurrences. These antibodies are indeed able to destroy HSV infected cells before new viruses are produced and may so limit the cell-to-cell spread of the virus and consequently decrease the severity and frequency of the recurrence.

Other immune mechanisms are involved in the defense against HSV, particularly the cytotoxic T cells. Presently we are exploring the effect of the vaccine on these cells and preliminary results in Balb/C mice suggest that the vaccine may increase the activity of these cells.

Although this was not a placebo-controlled study, our data nevertheless suggest that the vaccine reduced dramatically and significantly the frequency and severity of the recurrences. Because the booster effect of the vaccine on the immune system seems to last for 6 months, it may be necessary to give a booster injection at least once a year in order to maintain immunity levels that can reduce the frequency and severity of the recurrences.

As for drugs, vaccines involve risk to the recipient, but although the number of vaccinations is small, no side effects were reported with the exception of tenderness at the site of injection lasting for 24 hr in 60-70% of the patients. No other local or general reactions were observed even in those who received several booster injections

Further studies are needed to confirm the clinical efficacy, particularly a double-blind, placebo-controlled trial, since we know that a placebo effect exists in prevention of herpetic recurrences."

 

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Jimmyjimmyhuapua

I found a website where patients wrote about vitaherpavac, it was russian so i used google translate, it can be beneficial for all.

Comment a -Half a year ago, after a complete examination, treatment was prescribed, and a vaccine for herpes vitaherpack was also proposed. At first a little hesitated, but after reading about vitagerpakak reviews, calmed down and decided on vaccination. Every 7 days I was given an injection, it took five weeks, it was good that there was no herpetic rash between the injections, otherwise everything would last longer. Five months I live quietly, without herpes, in a month I'm going for a second vaccination and I hope that the herpes will go completely dry.

 

Comment b - I'm a surgeon. My patient H. after an appendectomy herpes simplex virus type II (a blood test for antibodies to herpesvirus was done) was often recurrent (clinical manifestations every two months for three years) current. Relapses were stopped by valtrex and famvir, then only by famvir. When I found out about the vaccine, I recommended it. Vaccination was successful, N. has no relapses for six months. Thanks to the manufacturer for Vitalpavak, the most effective method of herpes therapy after the fact. I plan to recommend vaccination to all patients with such an infection.

Comment c- The recurrence of herpes on the lips in my case was able to overcome the vaccine against herpes vitaherpavac, although before that I tried a lot of all kinds of antiviral drugs. Vaccination was easy, although the doctor warned that there could be rashes during the vaccination course. Prior to the vaccination was a thorough fortifying procedures, which are mandatory for the preparation of the body for vaccination for less resistance. I'm happy with the results, I'm going to take another course.

 

Comment  d -Herpes simplex became ill recently, before that, I have never had herpes in 24 years. It's really hard to live with him, this infection always comes at an inopportune moment, so I decided to go to his treatment cardinally and vaccinated the vitagerpak, which I was advised to go to at the medical center. The vaccine + from herpes vitagerpak was effective enough, for six months no new rashes. The only thing I do not like so much is the duration of the Vitagerpak vaccine - 5 injections for 5 weeks. But what can you do, the main result, but it is!

Comment e - Many thanks to developers and manufacturers! Suffered herpes for 30 years! The doctor herself, tried the whole arsenal, including the institute of immunology and the herpetic center. Acyclovir drugs stopped helping in 10 years. I waited very much for the vaccine, but all the coryphaea from immunology were bred by hand - it's hard to develop ... Even when I was studying at the institute, I learned the way to autoimmunization - I had to pierce the herpes vesicle on a sterile surface, mix it with water for injection (0.2 ml) and enter inside the skin as Mantoux. One such injection was enough for a year, but I wanted a more scientific method and not to wait for it to blow up. And this is salvation! For 5 years now I have been taking a regular schedule, which is attached to the instructions and I am ready to do it all my life, since the vaccine does not provide medical preventive and immunity!
 

Comment f - Genital herpes can not be defeated completely, as it persists in the cells for life, but it can be introduced into the stage of remission, in my case the Vitagerpak vaccine coped well with it. She believed in the vaccine after hearing about the vitagerpakak doctors' reviews, and in her effectiveness was convinced after the first vaccination, especially when compared with my extensive experience of treatment, after which in a few weeks the symptoms of herpes returned. At this stage I have already completed a course of 5 vitagerpak vaccines and are preparing for the second, during this time the disease did not return.

Comment g - The vaccine does not help at all !!! Moreover, after it or her at me the lymphonodus has spread! I regret very much now that I did it in general!

Comment h - vitagerpak did in July 2014, helped, while there are no manifestations, I will continue, it's time.

Comment i - I went through a full vaccination (including the second time in half a year). Does not help. Rashes appeared a month after the last course, as a result of heavy physical exertion and the subsequent acceptance of alcohol. Respiratory diseases generally do not ache, but the body is exhausted by constant nervous stress.

 

Comment j - How much I Acyclovir and Valtrexa has erased during the time that I have herpes, this mind is incomprehensible. Nevertheless, once in a couple of months, a relapse occurred. And in one of the remissions, the doctor decided to inject me with this vaccine. Then it was necessary immunostimuljatory still to spend on drink a vaccine in the help. And my remission is still going on - and this is more than a year. For me, this is a huge relief, since the soreness was terrible every time.

 

Comment k- I recently injected a third vaccine, I treat type 1 and type 2 herpes, for the entire period that I do the vaccination, there are no foci of excitation of new ones, old vowki gradually began to go away, at the moment I am very happy with the results, I very much hope that the vaccinations will help me cope with herpes finally

Comment l- was vaccinated with vitagerpakam on the advice of a doctor before pregnancy, everything went well, no reactions to the drug occurred, and the number of relapses was very reduced. Three months after the vaccination, she got pregnant and gave birth to a healthy baby! Before that, I suffered from vaginal herpes for a long time.

Most of comments are positive the website link is : https://www.piluli.ru/product/Vitagerpavak/review

On Another website some comments ; 

Comment 1 - it is a vaccine for people suffering from herpes, which is very often aggravated .. the doctors say that after a full course of treatment and the subsequent injection of this vaccine, there are very high chances that if pregnancy, cold sores will not bother, and even if it does, it will not affect the future child.

Comment 2 - Before the treatment jumped very often. already several times a month! I drank some pills, but nothing helped, it was terrible, no intimate life, then I went to Herp. center, there Pts. a good doctor began to treat me for this ailment. passed the immunogram, the results were bad, the immune system was very weak, then gradually they gradually treated me (already in three stages), in total, the treatment took more than six months. The recent imunogram is very different from the first. and here is the most recent stage the doctor appointed a vaccine. I do not know if it will help .. but as it was before and now - it's heaven and earth !!

Comment 3 - I, too, this topic is interesting. I have already despaired of curing, it is more accurate to drive into remission herpes. I have relapses several times a month. Many things I tried and injections and valtrex almost half a year and homeopathy, the result is almost equal to 0, as soon as I stop to drink valtrex again relapse. Oh, and what a herpetic center? where is? 

Comment 4 - For a very long time she suffered from herpes until she was vaccinated. It was enough for exactly 10 years. I could help even more, just the year was very stressful, the immunity fell and he again appeared. Now I'm doing the vaccination again, I know exactly what will help, the thing is very good. And the children will be exactly, I have 2

You should read more because women comment a lot here :)) When they start to talk its hard to stop them

 

Link :http://www.woman.ru/health/medley7/thread/3840857/

 

I see people are glad from results, especially before birth doctors recommends vitaherpavac for baby.

 

 

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mimi1988

This vaccine has been around since 2010, does anyone know why its not available in the US

On 2/25/2018 at 7:06 AM, Moromoro said:

His team is not working with anymore I thought?

 

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wildman

The short answer for "why it's not available in the US" is that inactivated HSV vaccines are essentially old technology (1980's). They are not likely to be very effective for most people, and any effect (that there might be) is likely to wear off relatively quickly. Some people claim to see a benefit from it, but there has never been a good placebo-controlled study proving it one way or another ("placebo effect" can sometimes have a significant impact).

The main rationale for why it's never been available (legitimately) in the US is because of the limited presumed benefit (just for argument sake, let's say it might have 10-50% symptom reduction for some (minority?) fraction of people who take it, maybe with some claiming better and many with not much of an effect, on top of the natural cyclical variations in viral activity over time, which may explain a wide range of different reported patient experiences, plus some unknown placebo effect), AND the limited duration for most people (maybe 6 months or so, based on the fact that many "advanced" attempts at vaccines appear to only last that long). So for this Russian vaccine, which requires 5 injections, spaced weekly, per go-round, that's a lot of expensive doctor office time, and then to repeat all that every 6 months, for (as noted) questionable benefit? Not cost effective. Never going to make it to the US (at least not legitimately). Maybe Valtrex isn't all that great either, but it's significantly better than that, for most anyway.

Inactivated HSV vaccines have been widely used in the past without complications, so it's probably not much of a health risk to try it - if you are willing to learn how to properly self-inject a vaccine, sourced from Russia. And it's not too costly (if ordered online, or however one might prefer, from Russia somehow). Just don't expect too much in terms of "miraculous" results, and be ready for any benefit (that there might be) to likely wear off within 6 months or less . . ..

As an interesting aside, the Russian vaccine is also a cheap source of inactivated HSV 1/2 for researchers or "bio-hackers." I would NOT encourage anyone to engage in any such activity, to be clear, unless they have some sort of legitimate science background, and a bunch of time and money on their hands, that they want to fritter away, pursuing science at their own cost and risk . . . in that case, please proceed . . . in any event, the inactivated vaccine could theoretically be purified by a researcher/"bio-hacker" to extract a relatively high-purity native HSV1/2 protein subunit mix. An older report I posted in this thread described such a "native subunit" vaccine being created and tested in humans in 1985, with somewhat interesting results (measured in a clinical trial setting). The inactivated vaccine by itself is probably significantly less effective than that, but "how much" less effective it's hard to say - the purification likely helps present antigens more clearly. Creating, or reproducing, some semi-similar version of that old 1985 purified vaccine obviously requires some lab skills, equipment, materials, knowledge, and would be a "science project" for people who like to do that sort of research for it's own sake - it would not be recommended to pursue such an experimental thing as any sort of treatment modality. Although the 1985 study had a decent number of people in it, it's not nearly enough to definitively prove either safety or efficacy (it was also not a placebo-controlled study), and it also did not show much durability beyond 6 months. Furthermore, any amateur attempt (outside of a professional lab setting) to recreate a similar protein extraction would very clearly face a number of technical challenges, and any theoretical result produced under less than ideal circumstances should be presumed to be "not safe" for use in people. For what it's worth, it would also be illegal / unethical to test anything in animal models, in any way whatsoever, without proper professional research credentials, permissions, safeguards, and paperwork (obviously). But, as previously noted, it should be possible, theoretically at least, for a person of sufficient skill and resources to reproduce the scientific work necessary to create a purified protein extract from inactivated HSV 1/2, or a variation of such, for research purposes. Outside the reach of US / FDA regulations, this could be a low-cost way for a researcher in a less regulated environment to access raw materials and create a broad-based subunit antigen set for use in building or testing a theoretical / affordable (if in some ways rudimentary) vaccine. Ideal? Maybe not. Safe for human use? Maybe not. But interesting nonetheless . . .

 

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l95

I repeate, this is very old vaccine, which was tested, probably in 1980x. I tried to ask here how it was tested, what was the proccess, when and who were participants. Nobody was able to answer clearly.   If I understood correctly,  the vaccive was tested in Institute of oftalmology, probably, participants were people with oftalmogerpes.  Chief of trials was prof. Kasparov, famous oftalmologist. I tried to ask his daughter who is well-known oftalmologist now, but she told that these trials had been made before she was born. I visited at least 4 well-known professors here who try to handle HSV, nobody prescribed this vaccine, just adviced to use  different sistems of valtrex. Becides I praticpate in major russian forums, and conclusion is - nobody who tried it  had long stable effect. Complicated sistem of injections, impossible to administer it if you have ourtbreak, so you need to use valtrex to manage it etc.  So, mostly, people here looked at USA trials waiting for miracle.

Edited by l95

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wildman

Most tests of inactivated HSV vaccines were conducted in the 1980's and they were typically not placebo-controlled studies. As far as I know, no one has done a modern-standard placebo-controlled study on inactivated HSV in humans, although multiple versions of inactivated HSV vaccines have been available to people at different times, outside of the US. Inactivated HSV has some effect in some animal models, but that's not directly comparable to humans, and some studies of purified protein extractions of inactivated HSV have been tested in both animals and humans, with some interesting effects (old study posted above).

The main reason why inactivated HSV / purified protein extraction approaches never became mainstream was that the therapeutic / prophylactic effectiveness was not great, and the durability never seemed to be longer than 6 months or so. A prophylactic vaccine with 6 month durability is basically pointless. There might be a niche case for a therapeutic vaccine with 6 month durability, to ease symptoms a little, and people could get booster shots, but not if it requires 10 doctor visits per year (like the Russian vaccine would if the instructions were followed), which is way too cumbersome. A purified protein extract is likely better than just inactivated vaccine would be therapeutically in humans (previously posted research study), but it's probably still not good enough for the FDA, at least not as a stand-alone treatment.

The same native antigens have been there all along in inactivated HSV, but researchers didn't (maybe still don't) have the ability to generate a durable effect using them, since they have lacked a proper "human approved" adjuvant that is safe enough and doesn't risk causing side effects (adjuvant development in general is still a work in progress, though advancements have been made since the 1980's). Research went in other directions since the 1980's, mainly toward narrow subunits combined with adjuvants, in an effort to demonstrate durability, safety, and effectiveness - as we know, much of that effort has come up short.

The problem is that researchers don't know conclusively what subunits are the best ones, or what adjuvant would work safely . . . and using a broader antigen set with a powerful adjuvant increases the risk a bit, even if that's where things are perhaps slowly heading - toward broader antigen sets and more powerful adjuvants . . . There is more money in cancer treatments and other diseases, so most of the important advancements in mainstream adjuvant research will likely happen there, and then maybe HSV research will benefit indirectly, once the cancer guys figure it out . . .

The materials to build a therapeutic HSV vaccine likely already exist, in all probability, based on animal models (which are directionally indicative, but not directly comparable to humans) - it just takes a long time (and a lot of money) to prove whether or not the various possible approaches are safe enough for human testing . . . and if the ones that can be deemed safe enough, are actually the ones that are effective enough . . .

And that's all without mentioning live attenuated vaccines, or advanced methods like DNA vaccines (none of which are approved for humans, but which some "bio-hacker" dude allegedly injected into his leg in front of a live audience - perhaps not a great risk/reward decision for the dude who did it, but no problem (probably) for the rest of humanity) . . . in a "prime-boost" approach, a subunit or DNA vaccine could be combined with a purified protein or inactivated virus "boost" - with the goal of getting both durability and breadth . . .

So it's not like inactivated HSV is useless . . . Far from it . . . It's just not going to do much on its own, although it might have some sort of therapeutic effect for some people (there is no conclusive study about that) . . .

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charly_c
2 hours ago, wildman said:

Most tests of inactivated HSV vaccines were conducted in the 1980's and they were typically not placebo-controlled studies. As far as I know, no one has done a modern-standard placebo-controlled study on inactivated HSV in humans, although multiple versions of inactivated HSV vaccines have been available to people at different times, outside of the US. Inactivated HSV has some effect in some animal models, but that's not directly comparable to humans, and some studies of purified protein extractions of inactivated HSV have been tested in both animals and humans, with some interesting effects (old study posted above).

The main reason why inactivated HSV / purified protein extraction approaches never became mainstream was that the therapeutic / prophylactic effectiveness was not great, and the durability never seemed to be longer than 6 months or so. A prophylactic vaccine with 6 month durability is basically pointless. There might be a niche case for a therapeutic vaccine with 6 month durability, to ease symptoms a little, and people could get booster shots, but not if it requires 10 doctor visits per year (like the Russian vaccine would if the instructions were followed), which is way too cumbersome. A purified protein extract is likely better than just inactivated vaccine would be therapeutically in humans (previously posted research study), but it's probably still not good enough for the FDA, at least not as a stand-alone treatment.

The same native antigens have been there all along in inactivated HSV, but researchers didn't (maybe still don't) have the ability to generate a durable effect using them, since they have lacked a proper "human approved" adjuvant that is safe enough and doesn't risk causing side effects (adjuvant development in general is still a work in progress, though advancements have been made since the 1980's). Research went in other directions since the 1980's, mainly toward narrow subunits combined with adjuvants, in an effort to demonstrate durability, safety, and effectiveness - as we know, much of that effort has come up short.

The problem is that researchers don't know conclusively what subunits are the best ones, or what adjuvant would work safely . . . and using a broader antigen set with a powerful adjuvant increases the risk a bit, even if that's where things are perhaps slowly heading - toward broader antigen sets and more powerful adjuvants . . . There is more money in cancer treatments and other diseases, so most of the important advancements in mainstream adjuvant research will likely happen there, and then maybe HSV research will benefit indirectly, once the cancer guys figure it out . . .

The materials to build a therapeutic HSV vaccine likely already exist, in all probability, based on animal models (which are directionally indicative, but not directly comparable to humans) - it just takes a long time (and a lot of money) to prove whether or not the various possible approaches are safe enough for human testing . . . and if the ones that can be deemed safe enough, are actually the ones that are effective enough . . .

And that's all without mentioning live attenuated vaccines, or advanced methods like DNA vaccines (none of which are approved for humans, but which some "bio-hacker" dude allegedly injected into his leg in front of a live audience - perhaps not a great risk/reward decision for the dude who did it, but no problem (probably) for the rest of humanity) . . . in a "prime-boost" approach, a subunit or DNA vaccine could be combined with a purified protein or inactivated virus "boost" - with the goal of getting both durability and breadth . . .

So it's not like inactivated HSV is useless . . . Far from it . . . It's just not going to do much on its own, although it might have some sort of therapeutic effect for some people (there is no conclusive study about that) . . .

Dear Wildman, the cost for 4-6 months with low or no symptoms with this vaccine and the use of Valtrex is a very good point of discussion here(also the negative or adverse effects of both options)!!!

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wildman

What if we wanted to develop a vaccine to reduce the spread of HSV in Africa?

Since HSV is a risk factor for HIV, and both are epidemics in Africa with significant public health consequences, the issue is potentially significant enough to warrant accelerated vaccine development. A vaccine that could reduce the spread of HSV would likely reduce the spread of HIV. Absent an intervention from Bill Gates, or some other source of funding, such a theoretical vaccine would need to be affordable and effective, and transportable in Africa, to make much of an impact.

Let's consider some options we might have:

1) Vitaherpevac / Inactivated HSV - good safety / many human administrations - efficacy/durability unproven / not well studied in humans (no placebo-controlled study, likely only mild benefit (if any) in humans, though anecdotal claims vary - difficult to conclusively test for efficacy without a large study, given placebo effect, natural variance in symptoms over time, etc.) - available (with some effort) from Russia. Affordable, but not effective enough (to invest in testing it or deploying it on a mass scale).

2) Purified Protein Extraction of Inactivated HSV - presumably acceptable safety profile / older in-human studies reported no major safety issues (tenderness at injection site for 24 hours in 60-70% of patients) / purified subset of the antigens present in inactivated HSV vaccines - in one (previously posted) study, antigen set contained 9 polypeptides (injections were 3 SC 2 weeks apart, antigen dose 1.5 ug/kg) - efficacy/durability as reported: interval between OB increased from 32 days to 87 days, healing time decreased from 9 days to 4.8 days (so patients in the study self-reported roughly ~40%-70% symptom reduction, on average), but with a lack of durability (decline in immune response was measured, requiring 6 month boosters) - study was NOT placebo controlled, but followed patients for 24 months and DID record immune response metrics (antibody and CMI) - purified protein vaccines are not commercially available (but inactivated vaccines containing the same raw materials are available with some effort, such as Vitaherpevac, etc.). Raw materials are affordable, possibly effective enough (but requires manufacturing expertise and frequent boosters - serious drawbacks).

3) GEN-003 - acceptable safety profile (through Phase 2 trials) - antigen set includes 2 subunit antigens, 60ug of truncated gD2 and ICP4, combined with  50/75ug Matrix-M adjuvant - efficacy/durability: 50-60% reduction in lesion rate, 30-40% reduction in asymptomatic shedding - study was placebo controlled, patients followed for 12 months after last dose - not commercially available (development halted, potentially could be revived for phase III trials, but lacks funding). Expensive, but probably effective enough (may not travel well in unrefrigerated conditions).

We'll exclude other less proven or more advanced vaccine options for the moment.

What would make sense in Africa if some government there wanted a vaccine and wanted it soon?

In many parts of Africa, access to advanced technology is limited and prohibitively expensive.  Could we build a rudimentary vaccine anyway? Might an African government, facing a legitimate public health crisis due to HIV, pursue testing or trials of something that the FDA might not? The sense of urgency and the risk/reward in Africa, after all, is far different than in the US. It might be a bit more like the conditions that allow some cancer patients to use "experimental" treatments, due to the urgency of the situation, but at a macro public health level.

GEN-003 would be great, theoretically, but it would make no financial sense in Africa. At low production volumes, the raw materials in a single vaccination course of GEN-003 might cost over $2,000 (or maybe more). The antigens are custom peptides that would require custom manufacturing in an advanced lab, and the adjuvant is a proprietary formulation that would have to be licensed and properly formulated, which isn't cheap either. There would also be the issue of refrigeration and storage. GEN-003 would not work in Africa unless it was subsidized, or mass produced elsewhere, and then distributed somehow, presumably at great expense.

But could a vaccine be produced locally in Africa? And would that cut costs enough? A GEN-003 imitation would be too complex for widely distributed local production. But what about a purified protein extract of the Russian vaccine? Let's assume that the older studies are correct, and that such a purified vaccine actually does reduce symptoms by 40% or more (perhaps a "too generous" assumption, and we don't have data on shedding, and we don't have a placebo-controlled study to rely on, but it is what it is - let's just assume 40% efficacy).

Could it be done? West Africa has a booming growth industry in meth labs, so there is already some unconstrained freelance "lab tech" talent available locally. Would the vaccine be safe? Compared to what? To meth? To HIV? A purified protein extraction seems highly likely to be safe in humans, assuming adequately sterile production conditions are maintained - but it likely wouldn't be very durable, so 6 month boosters might be required (a significant downside).

What about the cost? The Russian vaccine might cost $70 retail from some vendors, but that's a mark-up over the local Russian price, and a bulk order would likely have a discount. Let's use $70 though, to be conservative. Let's also assume the Russian vaccine is the only raw material required in terms of antigens. Equipment for a rudimentary protein extraction lab in Africa could cost as much as $500 (assuming used US lab equipment was purchased and shipped to Africa - used local African or Chinese lab equipment would likely only cost a small fraction of this). Even at small production volumes, making two or three doses at a time, labor costs would likely be well under $20 per dose of the vaccine (even assuming a generous $10/hour local "lab tech" wage).  The total production cost per unit would be very affordable, perhaps even profitable, to produce locally for local demand, even in Africa. A cost of under $100 per dose is pretty cheap, as far as low-volume vaccines go, and it would be a lot cheaper at higher volume. Even if efficacy was uncertain, or durability was only 6 months, that's a pretty compelling cost per dose, and a pretty compelling arbitrage opportunity, considering the unmet need. And someone could presumably run an affordable trial on volunteers locally, to substantiate the potential benefit, without too much expense or investment . . .

Presumably, an African government might not want to simply turn a blind eye to unauthorized production of such a thing (growing meth lab prevalence notwithstanding), but they might want to subsidize and/or license vaccine labs on a local trial basis if they felt the risk / reward was worthwhile - it would require very little upfront capital.

Going a step further, a researcher in China could likely test such a purified protein vaccine in humans in a placebo-controlled study, on behalf of an African government, or any foreign or local sponsor, for a relatively low cost (no FDA needed).  And going yet further, a Chinese researcher could also likely test such an "affordable" purified protein vaccine in humans, in combination with lower cost Chinese adjuvants, perhaps some that would potentially also be stable enough for lower-cost shipping and storage in African market conditions. But would that be safe? Who knows? It might not be very expensive to find out . . . a trial in China or Africa would be much cheaper, and easier to initiate, than in the US . . .

If it used a Chiese adjuvant of some sort, it might be riskier than something like GEN-003, not just because it is "untested," but because the native polypeptide antigens would be both more numerous (as many as 9 or more, possibly) and also longer vs. GEN-003's peptides, meaning that there would be at least some increased risk that some obscure sequence could be similar to something else, and might produce some sort of auto-immune effect that might be harmful - this is highly unlikely by itself (as older study showed no ill effects, and FI-HSV2 has been safe in widespread human use), and probably also unlikely with some types of adjuvant that are known to be relatively safe, but a real risk nonetheless, and the reason why a trial in humans would be needed to evaluate safety. No African government would want to be toppled as a result of giving people a vaccine that has some negative side effect, because they were too cheap to test it correctly, presumably with adequate risk disclaimers. Many vaccines can trigger the creation auto-antibodies or (rarely) auto-immune reactions in some people, even though clearly "worth the risk" in the aggregate, for most vaccines, but safety becomes more and more of a focus of regulators as time goes on. Of course, some researchers in China are already working on testing CRISPR in humans. That's probably far riskier than testing a purified native protein vaccine for HSV would be, at least depending on what sort of experimental techniques were used.

Maybe an African / Chinese solution to this problem doesn't need to wait around for the FDA? Of course, it wouldn't be "cure," but reducing HSV symptoms / transmission in Africa would be a highly significant public health benefit - more so than in the US, because of the HIV problem in Africa. More risk might be justified to accelerate progress, many would argue. And a rudimentary vaccine might be affordable, and easy enough to produce, to make local production possible on a distributed basis, reducing the need for refrigerated transport or established infrastructure.

If meth labs can flourish in Africa (or other developing markets with HSV/HIV epidemics), why not rudimentary HSV vaccine labs?  A quick and affordable study or trial program, to establish basic safety parameters and potential efficacy benchmarks, would be all that was needed to inform a realistic risk/reward decision about whether or not to allow or encourage broader scale local production. Then if the FDA ever does eventually approve a better, safer, cheaper solution to reducing the spread of HSV, it would be easy enough to switch over to using that instead . . .

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wildman

In the above post I used $70 for the cost of the Russian vaccine, for simplicity. Technically, $70 is for 5 vials, or one complete course of the Russian vaccine. If we were converting the Russian vaccine into a purified protein vaccine for use in Africa, we would technically not be using all 5 vials to make one dose of purified vaccine. The Russian vaccine includes inactivated HSV1 and inactivated HSV2, so the purified vaccine would also include the extracted proteins of both HSV1 and HSV2 (we are assuming a rudimentary protein extraction, not something expensive or technically difficult, like separating HSV1 antigens from HSV2 antigens - too costly, and there is some cross-reactivity anyway).

Assuming that the Russian vaccine includes ~200ug of total extractable protein antigens (a mid-range assumption - spectrophotometry could be used to verify locally, and it would be affordable to do this in Africa), and assuming protein is split equally, so 100ug HSV1 and 100ug HSV2, then we can see that the "cost per dose" would actually be much less than $70. Indeed, the PURIFIED cost per dose would likely be between $14 and $28 per dose (the cost of one or two vials of the Russian vaccine - assuming 1.5 ug/kg dosing). Depending on assumptions, this would drop the cost from "under $100" per dose to "under $50 per dose" (on average) . . . and then even cheaper from there, assuming any reduced mark-up, bulk purchase discount. or efficiency from higher volume production . . . THAT IS REALLY REALLY AFFORDABLE . . . EVEN FOR AFRICA . . .

Let's assume a Chinese researcher can quickly run in-human tests to prove safety and efficacy, enough to satisfy an African government's non-FDA standards. Then let's assume that a Chinese adjuvant (a T cell booster, perhaps one that has already been tested in humans for other purposes) can be quickly tested in this context, in humans (not a stretch by any means, outside of FDA limitations). Lets assume the adjuvant used can be freeze dried for shipping, costs $100 per dose, and is similar or outperforms the "Matrix-M" adjuvant used in GEN-003 . . . These are not unrealistic assumptions, at all . . . And, just like that, we would have a purified protein vaccine with greater antigen breadth than GEN-003, and potentially with a more powerful adjuvant (one that also would be better suited to shipping and storage in Africa) . . . . So then, if it's proven "safe enough" in human trials, such a vaccine could be used to cut the transmission rate of HSV in Africa by about 40% where it was deployed (assuming GEN-003 efficacy, then translating shedding rate to transmission rate) - or possibly MORE than the GEN-003 rate of efficacy could be attained, if a more powerful adjuvant was used (as noted, this would not be too difficult, if proven safe) . . . 

Even at only a GEN-003 efficacy level (probably not hard to beat, after removing the FDA from the equation), cutting the incremental HSV transmission rate by 40% in Africa would likely cut the incremental HIV transmission rate by 20% or more (assuming 80% HSV sero-prevalence, and 2-3x higher HIV risk due to pre-existing HSV - this is a simplistic/conservative assumption, because it only assumes an incremental benefit, as people who don't get HSV, as a result of the vaccine being deployed, would then be at less risk of HIV - but it is uncertain how the vaccine would affect the HIV risk of someone who already has HSV, which would require a study, and the results would be important (that's 80% of the population in some areas), but for now it's unknown, so we simply exclude it from the numbers) . . .. Is it worth attempting this? . . . Potentially cutting incremental HIV transmission rates in Africa by 20% or more! . . . Maybe significantly more  . . .  What would that be worth to an African government?

This might be the one of cheapest and most effective public health interventions possible in the World today (aside from developing a vaccine for Malaria, which is much more difficult) . . . And by "possible," I mean highly likely to work, with already existing technology and materials, at an affordable cost for both testing and production (outside of the FDA) . . .

Edited by wildman

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TCBH

The efficacy of the malaria vaccine is not great. Even approved it is still being tested.

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CR1984

This post is silent again. I have OBs on my legs. Red dots. Lots of itching. And sometimes pimple like rash. Cream helps. But once they go away new ones are already showing up around the area. Burning feeling all over. Genital area has no visible sympthoms but it feels itchy and burns. And the sweating sensation when OBs are coming back. This is every single month. 

Panavir:

I am going to order Panavir. It seems to be an inmune system booster and antiviral medication from Russia. There are papers on it. It is an extract of the potato plant.

Plants have well known antiviral properties.

Another example is the plant Cameachrista Nictitans. The yellow flower version. If you can get a hold of it. It is a wild plant from the tropics.

So Panavir and Vitaherpavak are the only available things for people like me that antivirals dont do anything or too few for us.

Latest is Pritelivir. Being researched and seems promising as antiviral. 1 dose 75mg will do per each OB. But not available to purchase yet.

Edited by CR1984
Typos

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whyme24

Well this vaccine may not be too effective for the people with herpes. But i recommend you to get your loved ones vaccinated. The transmission possibility will be far lower. Again if the transmission occurs, the symptoms will be way milder or no symptoms at all. Someone had told me that before i got this, i would have gotten vaccinated.

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whyme24
24 minutes ago, IamPositive said:

Is it really effective?? Even as prophylactic??

It will for sure decrease the transmission possiblity. But i dont know if it will decrease much or little. 

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GGinger
On 8/5/2017 at 7:43 AM, Mackie82 said:

Hey guys, if anyone is still following this thread I have already started my vitaherpavac shots and today I am getting the second shot. Thanks 

Can you email me Mackie gceceelia@gmail.com please I need more information about this.

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Skrillah80
On 7/16/2012 at 6:33 AM, airyfairy said:

Miracle

 

I am posting this for information purposes only, this is my experience, I want to share but am not recommending the same protocol. I do however believe that this is a true cure and that given enough time at the right dosage we can eradicate this virus totally. It is down to Paul's bravery and genius.

I was having constant pro-dome, every day for 6 months with no break, my body was on a loop, the same cycle every week, the only thing that helped a little was acyclovir at the acute dose, this was still not that effective. I tried every vitamin, mineral, oxygen drops everything I could lay my hands on and spent a fortune on oil of oregano. Nothing worked. I contemplated suicide seriously on more than one occasion. I felt that no one understood me and I was lower than ever in my life.

I read Paul's experience of the propolis and decided to give it a go.

I injected the left side of my vagina where the pubic hair is, the site of my ob. I did an inter-dermal injection with approx 0.05ml of propolis (mine came from new Zealand) it did hurt but it was bearable. The next day I experienced real jumping around in the ganglia which was normal, but I only got it on the side I had not injected, I thought OMG this is working. so I injected the other side of the vjj, the jumping around stopped.

Another symptom I used to experience was a deep painful ache at the base of my spine, I think that is where the virus lives, so I decided to inject as near as I could to the area without going into the spine. I chose the soft area of the buttocks, this time I did the sub q method but I used more propolis, about double the amount. The injection did not hurt at all. The pain in the base of my spine has now gone completely.

I cannot explain the difference in the way I feel except to say that I feel like I no longer have herpes, 95% of my symptoms have gone, I am left with a slight fluttering feeling down my thigh and buttock but everything else has just stopped.

I injected my pubis area again last night (against Paul's advice) he quite rightly thinks that we should all proceed with extreme caution.

I just know that NOTHING I have tried has ever come close to these results and they are nothing short of miraculous. I intend to continue topping myself up and have now ordered green Brazilian propolis as it is reputedly the very best.

I am so happy to be a human experiment , if anyone wants any more info please pm me and I will keep this thread going with regular updates.

I think it is ironic that milliions of dollars are being spent on cures, vaccines etc and a safe alternative could come from bee's!!!!!:nurse::nurse:

Wow!! I'm gonna give it a try here soon.. Where and how much should I Inject?

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BioHacker

People could theoretically make their own vaccine using the Russian vaccine as a source of cheap and human-safe antigen. Some formulations created on that basis would likely be effective therapeutically (as animal studies have hinted), but it would involve real risks to the "test subject" involved (human or animal). 

Usually the people who make their own vaccines are either biohackers or terminally ill cancer patients. It's not illegal, technically, to make a vaccine for yourself or to explain how to do it (as opposed to selling something, or administering anything as a treatment for someone else, or experimenting on animals - which is strictly regulated). Some materials are restricted and it can be difficult and expensive to do such things safely (or within "acceptable" risk parameters). Most people do not own the equipment needed for precise measurements and to maintain sterile conditions, though such equipment could be obtained at a cost. Obviously, there are many things that could go wrong or lead to adverse side effects when testing experimental vaccines, including risk of death (which is why animal testing is commonplace, if imperfect). The Russian vaccine is likely safe, but as soon as someone starts modifying it, then it might not be.

The recent progress with therapeutic cancer vaccines shows the ability of next generation adjuvants to trigger powerful immune responses in humans (with modest side effects), so reevaluating other potential therapeutic vaccine applications using advanced adjuvants in light of those studies makes sense. Caution should always be the rule though.

The rest of the speculation in this thread is not worth much.

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    • Franky26
      Hey @WilsoInAus   Thank you for your reply, we live in north America, she did the test here in Canada, I will attach a copy of the test below. I understand your point of view but its hard for me to cope with this. I never thought this would happen to me which I m sure most people feel the same.  yes I did took vows for better or worst but I feel those vows are for whatever happens after marriage not because of something happened in the past.  i feel like this is something that is going to remind me of her past for the rest of my life. its not easy for me to look past that.   
    • ayekayelle
      It was properly typed. Definitely HSV-2. No, he doesn’t get oral cold sores. So should I expect this to be another OB coming? I’ve never had an outbreak in my life and have been with my husband for 8 years with no problem! So I hope this isn’t going to keep occurring  
    • WilsoInAus
      Hey @ayekayelle I am afraid to say this is pretty typical of the first few months, a fairly high chance of rolling outbreaks. Maybe the suppressive therapy will be of assistance for a while at least. By the way just to add, was you culture properly typed? Or just assumed to be HSV-2 given location? Its 50/50 seemingly as to whether cultures are typed. Does your husband get oral cold sores?
    • ayekayelle
      I just had my first OB during the first week of April, and was diagnosed with HSV2 on April 12th. I just finished my 10 day cycle of acyclovir yesterday. Today I've been feeling uncomfortable. No burning or pins and needles feelings, just more so uncomfortable and not right down there. Is it possible to be getting another OB this soon, or am I just being paranoid? I'm starting suppressive therapy as soon as I receive my medication. Blah...
    • Quest
      Doesn't sound like HSV. You can get tested in 12 wks to be sure. Get rest 
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