Why don’t we have a HSV-2 vaccine yet?

“The true definition of madness is repeating the same action, over and over, hoping for a different result.” – Albert Einstein

A common problem in science is that the natural world does not always conform to our initial expectations about how things “should work.”  In a nutshell, this is the primary problem that has plagued herpes simplex virus 2 (HSV-2) vaccine research for the past 40 years.  I elaborate below.

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ORIGIN OF THE GLYCOPROTEIN SUBUNIT VACCINE APPROACH

The problems can be traced back to the 1970s when researchers thought (mistakenly) that HSV-2 might be a cause of cervical cancer in women……turns out human papillomavirus (e.g., Pap smears/ the recent Gardasil vaccine) was the real culprit.  Nonetheless, a belief system was created that a live-attenuated HSV-2 virus would be “too dangerous” to use as a human vaccine and so a search was begun for “safer” alternatives.  A major fear was that that a live HSV-2 vaccine (which would contain the virus’s DNA [genetic material]) could cause cancer in vaccine recipients.  In addition, the specter of a live HSV-2 vaccine that established a latent infection in vaccine recipients was another hypothetical concern although there is no scientific evidence to support the idea that a latent (silent) HSV-2 infection poses, in and of itself, a significant health risk to a human carrier.  Rather, all of the medical issues associated with wild-type HSV-1 or HSV-2 relate to the fact that these viruses can periodically re-awaken and cause new rounds of disease (e.g., recurrent cold sores or recurrent genital herpes).  By definition, a viable live-attenuated HSV-2 vaccine would be rendered incapable of causing either primary or recurrent herpetic disease.

If one accepts the 1970s-derived premise that a live HSV-2 vaccine would be “too dangerous,” then the early to mid-1980s saw the emergence of a solution to this potential problem.  Several high profile Science and Nature papers heralded the beginnings of the “HSV-2 glycoprotein subunit vaccine” approach.  In particular, scientists cloned one of HSV-2’s genes that encoded a target of the host immune response to HSV-2 named “glycoprotein D” (References 1-4 below).

With this new gene in hand, the belief was that scientists could artificially synthesize HSV-2 glycoprotein D (gD) in the laboratory in fabulously large quantities and this one piece, or subunit, of HSV-2 would be the basis of a HSV-2 vaccine that would be very safe and effective at preventing HSV-2 genital herpes.  For good measure, scientists also cloned a 2nd HSV-2 gene that encoded glycoprotein B (gB) with the idea that a combination of gB and gD might make an even better HSV-2 vaccine (Reference 5).

Thus, by the mid-1980s, it appeared that scientist had solved the potential safety problems surrounding HSV-2 vaccines, and could move forward with a new and improved approach……the HSV-2 glycoprotein subunit vaccine.  Unlike a live HSV-2 vaccine, purified gB and/or gD proteins contained no HSV-2 DNA, and thus could not cause cancer or establish a life-long, latent HSV-2 infection.  It is the promise and potential of these approaches to safely cure HSV-2 genital herpes that yielded several Science and Nature papers in the mid-1980s.  The next steps seemed simple…..just a matter of determining the optimal formulation of gB and/or gD that elicited a strong immune response when injected into vaccine recipients, and then we would have a safe and effective HSV-2 vaccine.

REFERENCES

1. Vaccinia virus recombinant expressing herpes simplex virus type 1 glycoprotein D prevents latent herpes in mice. Cremer KJ, Mackett M, Wohlenberg C, Notkins AL, Moss B.  Science. 1985 May 10;228(4700):737-40.

2.  Protection from genital herpes simplex virus type 2 infection by vaccination with cloned type 1 glycoprotein D.  Berman PW, Gregory T, Crase D, Lasky LA. Science. 1985 Mar 22;227(4693):1490-2.

3.  An immunologically active chimaeric protein containing herpes simplex virus type 1 glycoprotein D.  Weis JH, Enquist LW, Salstrom JS, Watson RJ.  Nature. 1983 Mar 3;302(5903):72-4.

4.  Herpes simplex virus type-1 glycoprotein D gene: nucleotide sequence and expression in Escherichia coli.  Watson RJ, Weis JH, Salstrom JS, Enquist LW. Science. 1982 Oct 22;218(4570):381-4.

5.  Expression in bacteria of gB-glycoprotein-coding sequences of Herpes simplex virus type 2.  Person S, Warner SC, Bzik DJ, Debroy C, Fox BA. Gene. 1985;35(3):279-87.

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ONE SMALL PROBLEM (1990s)

The glycoprotein subunit vaccine approach of the mid-1980s finally made its way to efficacy (effectiveness) trials in the 1990s, and now it was time to find out if immunization with gB- and/or gD-based vaccines either (1) reduced the symptoms of genital herpes in those already infected with HSV-2 or (2) protected naive individuals from acquiring HSV-2 genital herpes for a period of 2 to 5 years after vaccination.  On both counts, gB- and/or gD-based subunit vaccines were a disappointment.

Vaccination with gB- and/or gD-vaccines elicited a strong antibody (immune) response against the HSV-2 proteins contained in the vaccine itself, but this immune response did not render vaccine recipients any better off in their ability to fight off infection with the actual HSV-2 virus.  In particular, the gB- and/or gD-based vaccine failures of the 1990s may be found in the following four research publications:

1990.  Double-blind, placebo-controlled trial of a herpes simplex virus type 2 glycoprotein vaccine in persons at high risk for genital herpes infection.  Mertz GJ, Ashley R, Burke RL, Benedetti J, Critchlow C, Jones CC, Corey L.  J Infect Dis. 1990 Apr;161(4):653-60.

1994.  Placebo-controlled trial of vaccination with recombinant glycoprotein D of herpes simplex virus type 2 for immunotherapy of genital herpes.  Straus SE, Corey L, Burke RL, Savarese B, Barnum G, Krause PR, Kost RG, Meier JL, Sekulovich R, Adair SF, et al.  Lancet. 1994 Jun 11;343(8911):1460-3.

1997.  Immunotherapy of recurrent genital herpes with recombinant herpes simplex virus type 2 glycoproteins D and B: results of a placebo-controlled vaccine trial.  Straus SE, Wald A, Kost RG, McKenzie R, Langenberg AG, Hohman P, Lekstrom J, Cox E, Nakamura M, Sekulovich R, Izu A, Dekker C, Corey L.  J Infect Dis. 1997 Nov;176(5):1129-34.

1999.  Recombinant glycoprotein vaccine for the prevention of genital HSV-2 infection: two randomized controlled trials. Chiron HSV Vaccine Study Group.  Corey L, Langenberg AG, Ashley R, Sekulovich RE, Izu AE, Douglas JM Jr, Handsfield HH, Warren T, Marr L, Tyring S, DiCarlo R, Adimora AA, Leone P, Dekker CL, Burke RL, Leong WP, Straus SE.  JAMA. 1999 Jul 28;282(4):331-40.

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PROBLEM COMPOUNDED (2000-present)

In the 1990s, it was perfectly reasonable for scientists to focus on testing the new glycoprotein subunit approach as a potential means to cure and/or prevent HSV-2 genital herpes.  However, on the heels of 4 failures between 1990 – 1999, one might think that at the very least this would have served as a cue that scientists should consider a 2nd approach.  To put this in very simple terms, if I were trying to find a date for the prom, and had asked the same girl out 4 times, and all 4 times had been rejected and/or kicked in the groin, I would hope that on my 5th and 6th attempts at finding a date, it might occur to me ask a 2nd girl.  However, in the HSV-2 vaccine research sphere, this has not been the case…..the vast majority of money for HSV-2 vaccine research between 2000 and 2013 was still put toward determining if gB- and/or gD-based subunit vaccines could be used to prevent HSV-2 genital herpes.

Specifically, two more U.S. clinical trials were run to evaluate the efficacy of a gD-based vaccine in preventing HSV-2 genital herpes, and both trials failed to reveal any clear-cut evidence of protection.  These two failed clinical trials may be found in the following research publications:

2002.  Glycoprotein-D-adjuvant vaccine to prevent genital herpes.  Stanberry LR, Spruance SL, Cunningham AL, Bernstein DI, Mindel A, Sacks S, Tyring S, Aoki FY, Slaoui M, Denis M, Vandepapeliere P, Dubin G; GlaxoSmithKline Herpes Vaccine Efficacy Study Group.  N Engl J Med. 2002 Nov 21;347(21):1652-61.

2012.  Efficacy results of a trial of a herpes simplex vaccine.  Belshe RB, Leone PA, Bernstein DI, Wald A, Levin MJ, Stapleton JT, Gorfinkel I, Morrow RL, Ewell MG, Stokes-Riner A, Dubin G, Heineman TC, Schulte JM, Deal CD; Herpevac Trial for Women.  N Engl J Med. 2012 Jan 5;366(1):34-43.

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WHY DON’T WE HAVE AN EFFECTIVE HSV-2 VACCINE?

The answer to this question is actually relatively simple.  If one considers the total number of man-hours and financial resources dedicated to trying to find a genital herpes vaccine, we keep investing >99% of those resources into retesting new iterations of the same glycoprotein subunit vaccine approach that has been failing for >20 years.  In contrast, a concerted effort has not been made to support other, alternative HSV-2 vaccine approaches that might be far more effective.

The fact that the gB- and/or gD-based vaccines have failed in six clinical trials spanning 22 years and involving nearly 15,000 human participants does not seem to have dampened the enthusiasm of scientists for continuing to take this same basic approach, repackaging it, renaming it, and trying it yet again.

I would suggest that the key to developing an effective HSV-2 vaccine lies in acknowledging the possibility that a glycoprotein subunit may not represent the ideal HSV-2 vaccine approach, and thus considering (for the first time) a fundamentally different approach in the next human clinical trial of a HSV-2 genital herpes vaccine.

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PROBLEM DEFINED

In principle, we have at least 5 potential approaches at our disposal to develop a safe and effective HSV-2 vaccine, and these are:

1.  A live, attenuated variant of the HSV-2 virus (this approach accounts for most of our medically successful viral vaccines);

2.  A replication-defective HSV-2 virus (e.g., the ACAM-529 vaccine developed by David Knipe and Sanofi Pasteur);

3.  A killed, inactivated HSV-2 virus (e.g., the Skinner vaccine described in the 1970s and 80s);

4.  A subunit vaccine based on some of HSV-2’s other 75 proteins;

5.  A HSV-2 glycoprotein subunit vaccine based on gB and/or gD (~3% of HSV-2’s total proteins).

 

At the top of this post, I provide two pieces of data that illustrate that HSV-2 vaccine researchers have effectively become overinvested in the HSV-2 glycoprotein subunit vaccine approach, and have not given an equal level of attention to other HSV-2 vaccine approaches that may be far more effective.

The graph on the left illustrates that over the past 40 years (1973 – 2013), scientists and clinicians  have published 250 papers on gB- and/or gD-based vaccines to prevent HSV-2 genital herpes.   During that same period of time, 11 papers have been published on live-attenuated HSV-2 vaccines.  By this measure, we have invested ~25-fold more effort into exploring the glycoprotein subunit vaccine approach relative to a live-attenuated HSV-2 vaccine.

The graph on the right illustrates that over the past 40 years (1973 – 2013), scientists and clinicians  have enrolled nearly 15,000 human patients in U.S. clinical trials of gB- and/or gD-based subunit vaccines to prevent HSV-2 genital herpes.   During that same period of time, not a single human patients has been enrolled in a U.S. clinical trial investigating the safety or efficacy of a live-attenuated HSV-2 vaccine.  Although scientists often speak of the potential dangers of a live-attenuated HSV-2 vaccine, rarely do they discuss the relative risks associated with singlemindedly testing a HSV-2 glycoprotein subunit vaccine that keeps failing in clinical trials; each year that we continue to lack an effective HSV-2 vaccine means that another 20 million people will continue to be infected with wild-type (disease-causing) strains of wild-type HSV-2.

Perhaps it is time to go out on a limb and consider, for the first time, a different HSV-2 vaccine approach in the next U.S. clinical trial that might be more likely to actually prevent genital herpes.

In subsequent posts, I will elaborate on the published data that says that either a live-attenuated HSV-2 vaccine or a replication-defective HSV-2 virus (ACAM-529) would be very safe, and should be at least 10 to 100 times more effective at preventing HSV-2 genital herpes than the type of glycoprotein-based subunit vaccines that have been failing in human clinical trials since 1990.

– Bill Halford

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“The true definition of madness is repeating the same action, over and over, hoping for a different result.” – Albert Einstein


110 thoughts on “Why don’t we have a HSV-2 vaccine yet?

  1. What does this mean in layman’s terms? :
    Background: The aim of this study was to evaluate the possibility of using the anti-varicella zoster virus (anti-VZV, also known as anti-HSV3) vaccine against orobuccal herpes simplex virus type 1 (HSV1) and genital herpes simplex virus type 2 (HSV2). This was suggested by study of the phylogenetic tree of members of the herpes virus family, which showed a close relationship between VZV (HSV3) and the HSV1 and HSV2 herpes viruses.
    Methods: The present prospective study was conducted from January 2005 through January 2011. Twenty-four patients afflicted with HSV1 and HSV2 herpes recurrences over a period of years, numbering 6–8 and more recurrences per year, agreed to receive the anti-VZV vaccine. They were compared with 26 nonvaccinated patients presenting with herpes simplex diseases 2–5 times a year. All 50 patients were documented with anti-HSV1, anti-HSV2, and anti-VZV antibody serological testing.
    Results: From 2005 through 2011, for the 24 anti-VZV vaccinated patients, the average number of herpes relapses decreased to 0, correlated with an increased anti-VZV antibody level and clinical recovery of all patients, whereas no improvement was observed for the 26 nonvaccinated herpes patients.
    Conclusion: Data for the anti-VZV serological antibody levels tested before and after anti-VZV vaccination showed a significant (P < 0.001) increase among vaccinated patients. This suggests defective anti-VZV immune power in these patients. After 6 years of positive results for anti-VZV vaccine, this is a logical and fair hypothesis. We can now undertake a randomized study to confirm these findings…

  2. Thank you for taking the time to post here and respond to everything. I have read a lot of useful information here.

    I had read about the shingles vaccine *potentially* helping hsv-1 and hsv-2 infections. I have HSV-1. I’m hoping it helps, but we will see.

    Does anyone know if there has been any follow up research on the shingle vaccine and whether it aids or reduces symptoms for hsv-1? Just wanted to check in. It’s been 2 going on 3 years since the study was released from France.

    • Hi Kali,

      The overall impression I have from speaking with people who have HSV-2 genital herpes is that the VZV vaccine / shingles vaccine is not effective for preventing HSV-2 genital herpes outbreaks. That said, it cannot hurt to try and at least it will reduce your risk of contracting shingles.

      – Bill H.

  3. sir is that true there is vaccine for herpes virus or herpes can be cured by your vaccine ..if the vaccine had result good …it can be cured why cant get that medicine …everyone is waiting for that medicine

  4. is there any way to determine if you are in the viral shedding stage and when you are not? my concern is passing it to somebody..it would seem so simple to be able to take an at home test to know if I’m in the viral stage or not..you would be able to determine if you can sleep with your partner or not

  5. I have been reading this blog after multiple hours of my own independent research. Now I am really up to date. I have had HSV 2 for 42 years!!!! It has gotten so painful that I am on opiods all the time. My attacks occur twice a month and my life is very limited now. Would you consider treating me or would you recommend Pritelivir if it is approved? I have very little to lose at this point and everything to gain.

    Thank you in advance!

  6. Dr. Halford I do believe the steps set forth by Curious Observer are more than enough to get this ball moving in the right direction. The study done by the researcher in the dovepress article holds weight as a therapeutic alternative for the meantime (confession), as the answer is in a live vaccine. You’ve know this for some time now. The chickenpox vaccine lowers breakouts but the virrus is still present and transmittable. Long term side effects are unknown but the relief is worth it. Please take Curious Observer advice and keep us updated with the progress as you already have a sizeable funding group just on this message board.

    • Dear Interest,

      I already have a full-time job teaching medical students and doing biomedical research, and I have a family to support who greatly appreciate the paycheck that comes from my home university…..who pay me to teach medical students and do biomedical research.

      I am more than happy to share my knowledge and experience in this arena via this blog. However, the bulk of my time has to remain dedicated to what I already do (which typically occupies 70 to 80 hours of each week), which is the reason why my university continues to pay my salary.

      I am more than happy to pursue leads to investigate potential HSV-2 vaccine sites. However, raising the necessary capital to make this happen simply lies outside my job description, and outside of what I have the time and expertise to actually accomplish. What I have been trained to do, and what I am doing, is investigating how nature operates and what the basic rulebook looks like for a HSV-2 vaccine to actually work. I don’t think anyone really fully appreciated 10 years ago how badly off the mark the Herpevac (adjuvanted glycoprotein D) vaccine was as a HSV-2 vaccine, and only in the last four years has the scientific evidence started to mount that we really need to take a different approach if we want a HSV-2 vaccine that works. This is my job, and this is what I have spent the last 20 years training to do.

      Also, I note that if I had not done these things, then people such as yourself would understand that Herpevac did not work, but likely would be less likely to understand what we could do differently to get past the latest stumbling block. What I do, scientific research, is important to figure these things out, and the fact is that there is still another 10 years of important science to do in this arena……both to (1) fully figure out why live HSV-2 vaccines work so much better that subunit vaccines and (2) start asking whether this is unique to HSV-2 or simply indicative of a general trend in all viral vaccines. If the latter is true, then perhaps we should start seriously considering a live HIV vaccine to prevent AIDS (which continues to kill nearly two million people per year).

      I agree that I have a role to play in the continued development of better / smarter HSV-2 vaccines. However, I believe that my role lies in identifying our past errors in logic, and highlighting the correct direction / strategy that will lead us to where we want to go……a world where HSV-2 genital herpes is vaccine-preventable. Fund-raising….and the 5,000-page documents and big business than underlies how vaccines are brought to market. I find them intellectually interesting areas, but not a place where I should invest the bulk of my time, which would preclude my ability to focus on the more important task today……of making obvious why past HSV-2 vaccines have failed, and what we could (and should) do differently moving forward.

      At the end of the day, I am just a science geek and my time is fully spoken for between the laboratory, writing papers, and teaching medical students. However, I would be happy to hook up with the right business partners who can use their expertise to raise capital and bring a new biomedical product, an effective HSV-2 vaccine, to market.

      – Bill H.

  7. Dear Bill,

    I have read many of your posts and research and would like to firstly congratulate you on taking such an interest in such a passively harmful virus. I say passive because I think this is how many regulatory bodies see and prioritise HSV-1 and 2 and accordingly allocate time and funding to it – ignoring at the same time the huge emotional and physical burden it causes so many right now, and many more millions to come. So I certainly can see the root of your frustration in the inaction of governing bodies such as the FDA and pharma companies. Indeed, quite frustrating.

    I have been investing in bio-tech companies for many years, most with very binary results as is the case with many of these ‘magically sexy’ drugs that rope investors in. Sadly, and more often than not, most of these are no better than buying yourself a lottery ticket with 3 of the 6 numbers coming up. No jackpot here.

    In a post previously, you discussed the options of taking your research abroad and asked readers for their opinion on viable options. As painful as it may be to have to circumvent your home territory, if you truly believe you are onto a winning vaccine this option should be of serious consideration to you (no doubt with strict consideration of ethical and moral issues involved).

    From my investor research previously, I have come across (as an example) Thailand as a country with better regulations (in my opinion) around human clinical trials. With sound research backing and perhaps by partnering with a local CRO, you may be able to fast-track your clinical research. As I understand it, approvals for clinical trials in Thailand can be as short as a few months. If funding is an issue, your vaccine might be a very suitable candidate for ‘crowdfunding’ especially given the vast number of people HSV impacts globally. Sometimes you just need to cut the red tape yourself.

    A book published by Dr. U Sahoo “Clinical Research in Asia: Opportunities and Challenges” highlighted many of these issues. It may be of interest to you, as may be the specific legislation around it. I will leave you with a couple of links, however, I am sure you have looked into some of this before.

    http://uk.practicallaw.com/6-500-8489 (in particular, check out the ‘Clinical trials’ section)

    I use Thailand as an example, but here is a list of other countries and their applicable regulation around life sciences.
    http://uk.practicallaw.com/resources/multi-jurisdictional-guides/lifesciences-mjg

    Good luck and I hope to see many more brilliant things from you.

    • Dear Curious Observer,

      Thanks so much for your thoughtful post, and such important observations from an investor’s point-of-view. Moreover, thanks for the detailed information regarding the opportunities in Asia, and specific resources that may assist me in learning more.

      I agree that I will have to cut the red tape myself, but I note that I don’t think it will take long from the time a clinical trial is approved until the enthusiasm / support for my HSV-2 vaccine will swell. My general observation in science is that if you leave even a single stone unturned, the naysayers will latch onto this one facet of the unknown and claim that what lies under that one particular stone will reveal why your hypothesis is fatally flawed. Never mind the fact that you looked under 100 adjacent stones in the same vicinity of science, and all of nature’s answers that lie under these stones consistently support your viewpoint, or hypothesis. Rather, the naysayers who don’t want your interpretation to be aligned with nature’s underlying truth will fixate on the unknowns that lie under that one last, remaining stone. However, once you overturn that 101st stone, and find that the results support what you previously found under the 100 other adjacent stones, then everyone suddenly says “Of course, we knew that would happen.”
      I am certainly not the first scientist to make this observation, as should be apparent from the words of the 19th century scientist Haldane (who was quite the smartass, and I totally admire him for his willingness to openly point out the folly of his peers). Specifically, J.B.S. Haldane formulated the four stages of scientific acceptance as:
      1. This is worthless nonsense.
      2. This is an interesting, but perverse point of view.
      3. This is true, but quite unimportant.
      4. I always said so.

      In the context of where I am with the HSV-2 vaccine research, all the animal data says that a live HSV-2 vaccine works ~100 times better than what we have been putting into human clinical trials for the past 25 years. Logically, there is no reason to suspect that the same will not be true in humans, but as of today, this stone remains unturned and the naysayers are very concerned about what I will find when I finally get the opportunity to look under that last stone in a human clinical trial. Based on 22 years of 60- to 80-hour weeks focused on studying nothing but the biology of herpes simplex virus, I am quite certain that there is only one possible outcome of a human clinical trial of a live- and appropriately-attenuated HSV-2 vaccine, and that is……ushering in a new era in which HSV-2 is a vaccine-preventable infection, and the epidemic spread of HSV-2 genital herpes may be brought to a close.

      As confident and certain as I am of the science (because this is what I spent most of my waking hours contemplating), my narrow focus makes me blind / unfamiliar with many other facets of life, and this is particularly acute in the case of all matters pertaining to business and the practical steps required to advance an effective HSV-2 vaccine to human clinical trials. So, I greatly appreciate your input, which without a doubt helps address my single biggest weakness, and offers some very concrete guidance of where I may look to learn more about an important and unexplored opportunity; namely, a potential clinical trial of a HSV-2 vaccine in Asia and particularly Thailand.

      Many thanks Curious Observer.

      Sincerely yours,
      Bill H.

      • Dear Bill,

        I must say, I certainly admire your passion, commitment and motivation to a seemingly impossible task on which you have clearly spent much of your adult working life towards making possible. As such, I am grateful for the opportunity to afford you some insight from my experience as a financial investor (although I am sure you can get similar advice locally if you seek it out).

        Sadly, as I think you have pointed out before, the so called “leaders and regulators” in your industry are not motivated by the same passion as you. They hold positions of power, reputation and money, all of which I am sure they wish to preserve and taking risks on your work is not necessarily a way to do so. Who can blame them? I don’t. It’s just how society works. We can either complain about it, or do something about it, if we have the means.

        You said in your reply above that you “don’t think it will take long from the time a clinical trial is approved until the enthusiasm / support for [your] HSV-2 vaccine will swell”. I cannot disagree with this, but who knows how long that will take? Could be next week, or next decade. Similarly, Sanofi’s HSV-529 trials will be another potential turning point, but again who knows how long that will take for the NIH and FDA to become “comfortable”?

        As such, if you are supremely confident in your science and that human clinical trials will bring proof and data to the table, in my opinion, I would seek to take some of the following steps:
        1. Gather support from your internal stakeholders and co-patentholders (if any, e.g. University etc) for off-shore human clinical trials. Potentially also agree royalty arrangements should the vaccine reach commercial viability.
        2. Establish your internal ethical and moral standards for human clinical trials.
        3. Contact a global clinical research organisation (CRO) with established presence in a suitable off-shore location and establish costing and time frames.
        4. Set a realistic budget for your full scope of human clinical trials and be as detailed as possible (i.e. phase 1 through 3 clinical, employee costs, overheads, etc). Begin a carefully planned crowdfunding initiative on website such as http://www.indiegogo.com/ or http://www.pozible.com/ alongside a smart social media strategy to spread the word.

        1 through 3 listed above may seem relatively easy, but funding is the real question mark. But here is some reassuring math (simple but illustrative). 1 in 6 of the 200 million adults in the US is impacted directly or indirectly by HSV. So let’s say 30 million people for argument’s sake. Let’s assume 60% of these people for whatever reason are unable to make any financial commitment. That leaves you 12 million people. If each of these people were to give just $1 to the cause, that would give you headroom of $12m to work with. And that’s just in the US. Your reach with crowdfunding and social media is global.

        These are just my two cents from a business perspective. Some of this or none of this may be possible for you as I don’t know your situation and circumstance with your research to date. However, if you think you can proceed in this way, I do hope that you do – for the sake of the millions who you could potentially be helping. Not to mention, when you put some human clinical test data on the table, I have no doubt those naysayers will swiftly move from step 1 to 4 in Haldane’s stages of scientific acceptance!

        If I can offer any further insight, or perhaps connect you to some “business minded” people who can help, please do get in touch directly.

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