How can we expedite HSV-2 vaccine discovery?

OVERVIEW

My earlier posts emphasize some of the reasons that past attempts to obtain a HSV-2 vaccine have not succeeded.

I now turn my attention to outlining two steps that, if implemented, would expedite the rate of HSV-2 vaccine development efforts, and these are:

Step 1.  Appropriate Use of Small Animal Models (i.e., De-Risking HSV-2 Vaccine Development)

Step 2.  Streamline the Path to Phase I Human Clinical Testing of HSV-2 Vaccines

There is too much ground to cover here in a single post.  However, I hope to provide a reasonably concise overview of these two critically important issues that, if addressed, would greatly accelerate the rate of HSV-2 vaccine discovery.  In subsequent posts, I will tie up the loose ends that are not fully covered herein.

The crux of the issue is that, for the past 30 years the FDA’s favorite HSV-2 vaccine approach, the subunit vaccine, has not made one iota of a difference in our ability to treat or prevent HSV-2 genital herpes.  During this period of time, tens of millions of people have continued to suffer with HSV-2 genital herpes, and hundreds of millions more have acquired HSV-2 genital herpes.

As we look down the road 20 years, to 2033, I would suggest that it is time for the FDA to become a little bit less singleminded in their concern about the ABSOLUTE RISK of a Phase I Clinical Trial of a new HSV-2 vaccine candidate in n=10 human volunteers.  Rather, I would suggest that it is time for the FDA to weigh the RELATIVE RISK of a clinical trial of a new type of HSV-2 vaccine versus the status quo that has allowed a vaccine-preventable disease, HSV-2 genital herpes, to continue spreading unchecked through the American public for decades.

I would suggest that the manageable risk of a live-attenuated HSV-2 vaccine would be vastly preferable to the HSV-2 genital herpes epidemic, which will still be ongoing in 2033, if the FDA continues to promote and foster a culture in which it is perfectly acceptable for scientists to say that “a live-attenuated HSV-2 vaccine would be too dangerous to test in humans.”  There is simply not a shred of evidence to support such baseless claims.  This common misconception about the “dangers” of a live-attenuated HSV-2 vaccine has been perpetuated by nothing more than ignorance of the facts.   To the contrary, there is a mountain of evidence that demonstrates that HSV-2 (or any other viral pathogen) may be very stably attenuated by using a combination of (1) the right kinds of stable genetic modifications (i.e., large deletions) placed (2) into one or more strategically-chosen viral genes.

I elaborate, as follows.

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STEP 1.  APPROPRIATE USE OF SMALL ANIMAL MODELS (i.e., DE-RISKING HSV-2 VACCINE DEVELOPMENT)

One of the primary tools by which new vaccine candidates are evaluated are small animal models, such as mice or guinea pigs.  The tests that scientists run on HSV-2 vaccines in mice or guinea pigs are an important component of “pre-clinical testing” in which we attempt to gauge how safe and effective a HSV-2 vaccine candidate would be in humans.

In recent years, increasing numbers of scientists have begun to question if mice and/or guinea pigs are really a good model for evaluating the effectiveness of new HSV-2 vaccine candidates.  Thus, some investigators have suggested that we should explore new animal models for pre-clinical testing of HSV-2 vaccines, such as mice or rabbits that have been “humanized” (i.e., to contain human immune cells) or primate models such as monkeys or apes.

I understand the desire to blame the Herpevac vaccine failure in human clinical trials on a bad animal model that “lied to us,” and told us that Herpevac would work in humans.  However, I note that in my own studies in mice and guinea pigs, I find that Herpevac-like, glycoprotein subunit vaccines are ineffective and elicit only a small fraction of the protection against HSV-2 genital herpes that is possible (Halford, et al., 2011, http://www.plosone.org/article/info:doi/10.1371/journal.pone.0017748).  If mouse HSV-2 vaccine-challenge models were intrinsically flawed, I would expect that the mice would lie to me, in the same way that other investigators have claimed that their mice and/or guinea pigs lied to them.

Animal models of HSV-1 and HSV-2 infection are the primary area of my research expertise. During my graduate training with two herpes immunologists, Dan Carr and Bryan Gebhardt (1992-1996), I became quite familiar with the literature on herpes immunology which dates back to the 1970s and earlier.  Over four decades, herpes immunology studies in mice have repeatedly informed us of new principles about the response of the verterbrate immune system to HSV, and these findings have generally translated well to the human condition.  There are nuances about the mouse model that don’t correlate with the human situation; for example, mice catch on to HSV-1 and HSV-2 reactivation REALLY FAST, as several viral immune evasion mechanisms that work well in humans don’t do their job in the mouse (e.g., ICP47 and gE-gI).  However, setting these minor differences aside, I see no hard evidence to support claims from other investigators that mice and guinea pigs are not a perfectly effective model for screening HSV-2 vaccines to figure out which approaches work (live-attenuated HSV-2 vaccine) and which are hopelessly ineffective (gD-2 subunit vaccine) at eliciting a protective immune response against HSV-2 genital herpes.

I once heard a vaccine researcher from Italy (working on a meningitis vaccine) express the same sentiment in a talk, but he was far more eloquent in his choice of words.  Apparently a similar dialogue about the reliability of mice was playing out in his field.  What he said went something like this: “Many people in my field think that vaccine studies in mice are unreliable and have no value in predicting which meningitis vaccines will work in humans.  Personally, I have not found that the mice lie to me, but I do find that it is extremely important to ask them the right questions.”

One of the most fundamental limitations of HSV-2 vaccine-challenge studies performed in small animal models is the CHRONIC ABSENCE OF A POSITIVE CONTROL, which may be used to empirically define what “100% protection” against HSV-2 genital herpes should look like.  Rather, most HSV-2 vaccine studies only compare naïve animals (0% protected) versus vaccinated animals, and conclude that the vaccinated animals were better protected than the naïve animals.  This is a good starting point, but the next, essential step is to measure whether the HSV-2 vaccine candidate elicits 0.3% protection against HSV-2 genital herpes (i.e., statistically significant, but useless) or alternatively elicits something close to complete (~100%) protection against disease.

To define how good a HSV-2 vaccine is on a scale of 0 to 100% protection, an investigator must include a positive control to define what one should consider as “100% protection against HSV-2.”  Such a positive control group may be established in a vaccine study by infecting a control group of animals with wild-type HSV-2 under conditions that limit the virus’s capacity to spread and cause disease.  A simple way to achieve this goal is to provide animals with oral acyclovir (anti-herpes drug) in their drinking water during the first 3 weeks of exposure to wild-type HSV-2, which limits but does not completely prevent viral replication and spread.  It is well established that any species of animal (mouse, guinea pigs, or rabbits) that survives a 1st exposure to HSV-2 will become latently-infected and uber-resistant to exogenous challenge with a 2nd dose of wild-type HSV-2.  This is one of many ways that a researcher may create a group of “HSV-2 latently infected animals” that would serve as a positive control that roughly approximates what “100% protection against HSV-2 vaginal challenge” might look like.

This technology has been around since the 1980s.  The chronic absence of “HSV-2 latently infected animals” in HSV-2 vaccine studies means that most HSV-2 vaccine researchers either (1) don’t know how to run a properly controlled animal experiment (which I doubt), or (2) don’t want to include a positive-control group that might reveal that their test HSV-2 vaccine is not terribly effective.

I close by noting that the mouse and guinea pig vaccine-challenge studies that initially served as proof that a Herpevac-like, glycoprotein D subunit vaccine “should be effective” did not include a positive-control group of HSV-2 latently infected animals.   Had such a positive control group been included, I am confident that a Herpevac-like, glycoprotein D subunit vaccine would have never advanced to human clinical trials because it would have been painfully apparent that this approach only elicits 2 to 5% of the protection against HSV-2 that is possible.

Flawed experimental designs, not bad rodents, are the real culprit that explains why small animal models have not served as a more realistic gauge of HSV-2 vaccine efficacy in the past.

A recent publication from my lab (http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0065523) elaborates on another misconception propagated by inappropriate use of animal models in the past; namely, the erroneous belief that there are no “correlates of immunity” available to quickly and easily differentiate a robust versus an anemic HSV-2 vaccine candidate.

BOTTOM LINE:  If the pharmaceutical industry wishes to “de-risk” HSV-2 vaccine development, then an important step in that direction will be to quit making multi-million dollar decisions based on subpar animal studies.  As with all other areas of scientific inquiry, the inclusion of a positive control group in HSV-2 vaccine-challenge studies would be a huge step in the right direction.

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STEP 2.  STREAMLINE THE PATH TO PHASE I HUMAN CLINICAL TESTING OF HSV-2 VACCINES

The FDA regulatory process is intended to protect the public against potentially harmful products that could be sold or peddled as “medical treatments.”  In the complete absence of any safety regulations or oversight, all forms of snake oil and worse could be sold under the guise of medical treatments.  As a consumer, I greatly appreciate what the FDA does for us U.S. citizens in terms of ensuring that the food and drugs we ingest are safe.  This is a critical public service whose value cannot be overemphasized.

In the realm of vaccines, the FDA applies the exact same logic to vaccines that they apply to food.  This is an error in logic.  Food items such as jelly beans are either safe, or they are not.  In contrast, when one obsesses over the safety of a HSV-2 vaccine and keeps it out of clinical trials for years to decades, this action has the consequence of allowing millions of people per year to continue to be infected with disease-causing strains of wild-type HSV-2.  Therefore, I would suggest that it is inappropriate to singlemindedly obsess about whether or not a new HSV-2 vaccine poses ANY RISK.  All vaccines pose a risk in the absolute sense of the word, but good vaccines pose a risk that is vanishingly small.  Therefore, a vaccine’s risk should be weighed in terms of RELATIVE RISK.  That is, what is the risk of adverse events associated with injecting people with a new HSV-2 vaccine candidate versus the risk of doing nothing and letting 20 million people per year continue to be newly infected with wild-type HSV-2?

Right now, the FDA regulatory approach towards new HSV-2 vaccine candidates focuses on assessing whether there is ANY RISK AT ALL that a HSV-2 vaccine might cause overt symptoms or disease if injected into a million vaccine recipients.  Importantly, the FDA regulatory process seeks to address this hypothetical question BEFORE A SINGLE HUMAN SUBJECT CAN BE IMMUNIZED in a clinical trial.  Of course, in the absence of the FDA allowing small-scale testing of new HSV-2 vaccines in humans (e.g., 10  subjects), it is impossible for a scientist to counter these hypothetical concerns with data that directly demonstrates safety in humans.

Hence, the FDA has created a “Catch-22″situation, which goes something like this:

1.  The FDA won’t allow a new HSV-2 vaccine to proceed to Phase I clinical trials in 10 – 20 human subjects until a laundry list of hypothetical concerns are addressed through pre-clinical testing in animal models.  No matter how strong the animal data, the pre-clinical data may always be met with a new set of “concerns” from the FDA that “OK, aspect A of the safety of the HSV-2 vaccine candidate looks good in animals, but what about aspects B, C, D, etc. which you have not addressed.”  Moreover, no matter how many iterations of tests you run in animals, the FDA may still tell you 5 years later that, “Well your HSV-2 vaccine is clearly very safe in animals, but how can we know that it will be safe enough in human recipients?”

2.  The formula for sufficiently addressing all of the FDA’s concerns about the safety of a new HSV-2 vaccine candidate may easily require 10 years and $30 million dollars in legal and paperwork filing fees, which a sponsoring company may or may not recover.  If all goes swimmingly well, then a company that backed a given HSV-2 vaccine might break even on their investment in 15 or 20 years.  This is obviously a huge disincentive for companies to get involved with sponsoring a new HSV-2 vaccine approach, as it will take 10 years just to figure out whether or not the approach has the potential to fly in humans.

3.  Companies are reluctant to invest 10 years and $30 million in a fundamentally new HSV-2 vaccine candidate that differs from the types of HSV-2 vaccines that the FDA has approved in the past.  Thus, even if HSV-2 subunit vaccines are lame, most companies would rather invest in a lame HSV-2 subunit vaccine that the FDA is likely to approve for clinical trials, rather than support a new type of HSV-2 vaccine that is more effective, but may never get the green light from the FDA to advance to human clinical trials.

BOTTOM LINE:  The FDA regulatory process with the respect to vaccines has grown so onerous, that it has stymied the interest of most companies in pursuing HSV-2 vaccine research.  While I appreciate the FDA’s desire for safety, the potential risks of new HSV-2 vaccines should be weighed against the risks of continuing the status quo of focusing only on “uber-safe” HSV-2 subunit vaccines that are unlikely to be effective, and thus permitting the HSV-2 genital herpes epidemic to continue to spread in an unchecked manner.

If a vaccine is well designed, then the odds of serious adverse event approach the odds of winning the lottery (i.e., one-in-a-million).  In contrast, the continued, unchecked spread of HSV-2 genital herpes in the human population means that tens of millions of people will continue to live with recurrent HSV-2 genital herpes, and hundreds of millions more will be newly infected with disease-causing strains of wild-type HSV-2 by 2033.

HSV-2 genital herpes is almost certainly a vaccine-preventable disease.  However, to achieve this goal, and bring the power of vaccinations to bear, the FDA will need to re-think its position on the pros and cons (RELATIVE RISK) of testing new classes of live-attenuated HSV-2 vaccines, which will likely be at least 100 times more effective than the HSV-2 subunit vaccines that we have been exclusively testing in human clinical trials for the past 25 years.

I would suggest that small-scale “Compassionate Use Trials of HSV-2 Vaccines” are a compromise that could be struck to achieve a more appropriate balance between (1) ensuring the continued safety of HSV-2 vaccine trials versus (2) offering people with HSV-2 genital herpes some real hope that a therapeutic HSV-2 vaccine may be identified in their lifetime.  Specifically, Compassionate Use Trials of a therapeutic, live-attenuated HSV-2 vaccines would achieve the dual goal of (1) timely testing of a new HSV-2 vaccine modality in humans and (2) testing of a HSV-2 vaccine candidate that offers the greatest odds for success of a therapeutic vaccine capable of reducing the frequency and duration of genital herpes outbreaks in those already infected with HSV-2.

In a subsequent post, I will elaborate more fully on the concept of Compassionate Use Trials, and how this might be coupled with human trials of a therapeutic HSV-2 vaccine to greatly accelerate human testing of new classes of HSV-2 vaccine.

– Bill H.

18 thoughts on “How can we expedite HSV-2 vaccine discovery?

    • Someone e-mailed me the following comment / question last week:

      Hello sir

      I have read some of your posts. As a frustrated herpes sufferer I ask the following question and would like to know…. if most companies are taking the wrong approach to developing a treatment/cure/vaccine and you seemingly have the right path and understanding, why are you not working with these companies or developing a treatment on your own ?

      Thanks and regards,
      Anonymous

      ———————————————

      I respond, as follows:

      Dear Anonymous,

      I have approached numerous companies directly, and I have presented my work at numerous vaccine meetings in hopes of speaking with the representatives of one or more major pharmaceutical companies. I am also trying to develop a treatment on my own, but the logisitical hurdle in the U.S. is that the conventional process to bring a biomedical treatment to market through the FDA / regulatory process costs 30 to 100 million dollars to get the ball rolling. Thus, companies pick and choose very carefully which products they think achieve the best balance between (1) likelihood of timely FDA approval, (2) likelihood of clinical success, and (3) long-terms sales potential. If a company looks at a potential biomedical product as likely costing $250 million to fully take to market, then they understandably are asking, “How long would it take to recover that $250 million and start turning a profit?” Viagara is a big seller; vaccines have a much more modest potential for profit, and have developed a reputation as high-risk investments (i.e., our overall vaccine success rate in clinical trials is well below 10% and may even be below 1%).
      People in the U.S. love leaving everything to a “free market economy.” As long as the FDA regulatory process remains uber-expensive, the rules of our “free market economy” dictate that companies will selectively go after the development of those biomedical products that are (1) not controversial, (2) may be relatively quickly approved, and have (3) immediate potential for big profit.

      Bottom line, I am trying to do precisely what you suggest. However, the simple reality is that what you suggest falls into the category of “Easier said than done.” Will keep trying, but this is a long-term fight that will require me to keep debating with companies, the NIH, and other scientists about which types of HSV-2 vaccines should be our highest priority so that we invest our time and money wisely in this arena.

      – Bill H.

    • Hi Craig,

      Coridon (Ian Frazer’s company) published the following paper in October 2013: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0076407

      It looks like a very well executed study in a mouse model of HSV-2 genital herpes, which actually includes a live-attenuated HSV-2 vaccine as a positive control for robust protection against HSV-2 genital herpes.

      This is a step in the right direction. Beyond that, I cannot meaningfully speculate on how it would perform in people, but with time perhaps we will find out.

      – Bill H.

  1. I do not have the time this evening to read all, but I wanted to get a note off to you on a few ideas. India claims to have a cure for herpes. What they use I do not know. Also, in veterinary medicine a canine herpes vaccine is available. The info gathered says that the vaccine for the dogs seems to make the virus remissive so the female dog can have a successful birth and not pass the disease to the child.
    Now, veterinarians deal with dogs but curiously dogs get herpes. Is there a similarity in the virus or not? If there is can there be some sort of copying going on for humans?

  2. Dear Dr. Halford,

    I tried posting this as a comment on your blog, but kept getting
    “ERROR: Empty CAPTCHA”

    Have you given any thought to crowdfunding for an HSV vaccine trial ?

    Do you think it would be possible to raise enough money on Indiegogo
    or Kickstarter, to hire a lawyer, a lab assistant, etc., for a period
    of time to find a country, legal arrangement, etc. that would allow
    people to fly to some country, sign a disclaimer, receive a dose of a
    live attenuated HSV strain vaccine and participate in a trial for the
    vaccine? Funding a preliminary logistical project could put funders in
    line for participation in any trial utilizing the preparations from
    the initial campaign. If some day a good candidate is found, there
    could be subsequent crowdfunding campaigns for producing doses of the
    vaccine, setting up venues, etc.

    I don’t have much of a clue with regard to biotech, but I am sure it
    would be possible to raise millions of USD in a series of such
    crowdfunding campaigns for such a project. It seems more important
    than this: http://www.indiegogo.com/projects/ubuntu-edge. I volunteer
    my time as a crowdfunding evangelist/worker/techie/promoter/recruiter
    if you are interested. I’m a software engineer so I could handle all
    technical / web aspects.

    Thank you for your time.
    BM

    • Dear BM,

      I have returned from my trip, and have had more time to look at the weblink you provide and answer your overall question about fundraising to support the deployment of a safe and effective HSV-2 vaccine into human clinical trials. To date, my experience with fundraising for HSV-2 vaccine development efforts has met with marginal success. While a few individuals have been incredibly generous and donated between $500 and $2,000 to the research, it is difficult for my lab to operate on a donation-to-donation basis, when the time between significant donation amounts is often on the order of 9 to 18 months. For example, if I wanted to hire a technician to help produce HSV-2 vaccine stock or some other task that would help with the effort, a modest salary and fringe benefits for that person would run about $4,000 per month. If we factor in the cost of a modest research supply budget for that person, that would now involve about $5,000 per month. Based on donations my lab has received over the past 3 years, I could support such a person for 6 weeks, which would be enough time to train them to do a fraction of what I would need them to eventually do.

      Based on my past 6 years of experience with similar concepts that you offer, my experience is that the idea of millions of people with genital herpes donating $10 each to fund the development of an effective HSV-2 vaccine always sounds good, but I simply have yet to see that this works.

      In contrast, the weblink you provide is talking about selling some computer-based product that people can use on their iPhones. I note that Americans (and investors) are more than happy to spend millions to billions of dollars per year on computer gadgets that are highly marketable. Likewise, we drop similar amounts of money on entertainment, such as tickets to see professional baseball, football, or basketball games. However, money donated for the general welfare of others without an immediately useful product attached just does not seem to generate the same level of enthusiasm for people to part with their hard-earned money.

      I very much appreciate your offer to help, but I am afraid that my time is limited and I simply have not seen the evidence to date that internet-based fundraising for science is a tenable model. Therefore, I will continue beating on the doors of the NIH and other funding agencies, as although the odds of funding have grown very low, a single grant can yield 0.5 to 1.0 million dollars, which could sustain my research program for another 5 years.

      Thanks,
      Bill H.

  3. Hi Dr. Halford, just wanted to inform you that as you had confirmed with Dr. Knipe, clinical trials will be starting soon for ACAM-529 (dl5-29) as they are now actively recruiting volunteers.

    http://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_2012-I-0121.html

    http://clinicaltrials.gov/ct2/show/NCT01593709

    There is no mention of the vaccine on the above trial pages, but someone accepted into the study was informed by the staff that the study is in fact for dl5-29 (http://www.herpes-coldsores.com/messageforum/showpost.php?p=322063).

    Hopefully this is a sign that the FDA’s view on live-attenuated vaccines for HSV is finally changing and that this translates into getting your vaccine approach to human trials sooner rather than later!

    Here’s to staying hopeful!!!

    • Hi Devastated,

      I am greatly encouraged that the ACAM-529 vaccine is proceeding to human clinical trials. This is a big and important step.

      However, I note that while the ACAM-529 vaccine is derived from the whole HSV-2 virus, it is not technically the same type of “live-attenuated” viral vaccine that we have used clinically in the past to prevent diseases such as smallpox, polio, mumps, measles, rubella, chickenpox, and yellow fever. These diseases were each prevented (at least in part) with a live-attenuated viral vaccine that contained a replication-competent virus (i.e., a virus that infects human cells and undergoes viral replication in human tissues). In contrast, the ACAM-529 vaccine is based on a non-replicating HSV-2 virus that is missing two critical HSV-2 genes that are strictly required for the HSV-2 virus to replicate in human cells. Thus, the ACAM-529 vaccine is not technically a “live-attenuated” virus, but rather is a “replication-defective” HSV-2 virus.

      Bottom line: I am encouraged that ACAM-529 is entering human clinical trials, and I feel that this is absolutely an essential step in the right direction. Moreover, I think that ACAM-529 will have a greater clinical benefit than the Herpevac vaccine. However, where I pause and have concerns is that I question whether or not the clinical benefit of the ACAM-529 will be sustained over a period of months to years in human vaccine recipients. I sincerely hope that it works, but I note that there is no precedent in the history of vaccine science that can tell us if this different type of “replication-defective viral vaccine” will be as clinically effective over a human lifetime as the live-attenuated viral vaccines we have used in the past. If the ACAM-529 vaccine succeeds, it will truly be a groundbreaking discovery. If the ACAM-529 vaccine falls short of the mark, then the next logical step will be to consider a HSV-2 viral vaccine that retains a limited capacity to replicate in human cells (i.e., a dinky-die live-attenuated HSV-2 vaccine).

      Yes, let’s all stay hopeful and focused on the good that people like Dr. Knipe and Sanofi Pasteur are trying to do in developing an effective HSV-2 vaccine. However, let us also remember that this is science, and we should hope for the best but also make preparations for the worst in dealing with all possible outcomes of our next experiment. If ACAM-529 works, great! Problem solved! If ACAM-529 does not succeed, then we should start taking steps to explore a more traditional type of live-attenuated vaccine to prevent HSV-2 genital herpes.

      – Bill H.

      • Dear BM,

        Thank you for your post. I am out of the country at the moment. i will reply to your very interesting post (sent to me via e-mail) upon my return.

        I apologize for the difficulty in posting this to the website. Will contact the webmaster upon my return.

        – Bill H.

  4. Hi Doc,

    Two things today.

    1. What about taking your work to other countries such as Denmark or Australia? Have you already? I gather their regulatory structures are much soother and more progressive.

    2. Assuming the HerpV vaccine is approved for next stage clinical III trials (results expected “the second half of 2013” from Phase 2)… if one chose to volunteer for this vaccine (knowing full well the HerpV approach addresses “only 2.5% of HSV-2′s proteome”)… would HerpV in a meaningful way block or interfere with a subsequent inoculation from a live-attenuated vaccine such as from your lab?

    Thanks for your time.

    • Hi Expat75,

      Happy to vaccinate people with a safe and effective HSV-2 vaccine on any continent / in any country. If a host company and/or country steps forward that is willing to make the necessary investment to bring my existing HSV-2 vaccine into a small Phase I human clinical trial (i.e., in 10 – 20 vaccine recipients with HSV-2 genital herpes), then I suspect they will quickly find they are in possession of a therapeutic vaccine that is worth billions per year in sales (i.e., 2 – 3 vaccinations per year to prevent genital herpes would be preferable to 2 valtrex per day).

      Just waiting for someone with the necessary capital and infrastructure to bring a new HSV-2 vaccine that works to market. As the saying goes, “You can lead a horse to water, but you can’t make ’em drink.” I am currently waiting for the biotech / pharmaceutical company types to catch up, and recognize that everything I have said in my publications and on this blog is the plain and simple truth.

      That is, we can either keep hoping that the next man-made, synthetic HSV-2 vaccine will work better than all the ones that have been failing since the 1980s, or we can say enough is enough and deploy an effective, live-attenuated HSV-2 vaccine (that is incredibly safe) tomorrow. This isn’t rocket science. Just waiting for the right company and/or host country to recognize that this is not only a good financial investment, but it is the right thing to do.

      – Bill H.

        • Hi Expat,

          I have been to three meetings in Italy, Colorado, and Greece in May and June for the purpose of spreading the word about how much better a live-attenuated HSV-2 vaccine works relative to what has been going into human clinical trials for the past 25 years. Also, will be going to big a Vaccine Meeting in Spain in October, 2013. However, you are right that I should look at targeting some meetings in countries that might be more willing to serve as hosts to test a new HSV-2 vaccine….China or India would be excellent candidates. Perhaps in 2014.

          – Bill H.

  5. Dr. Halford,
    Thank you for the research you do on this condition and the information you are providing on this blog.
    I would like to donate to your research via the instruction at http://herpesvaccineresearch.com/#Donate but I noticed, whether filing out the online credit form or sending a check, that there is no way to contribute without the word “Herpes” appearing on the tax documents.
    I was wondering if it would be possible to enter something like “The Halford Fund” or a routing number in the comments section. If it has to be that exact statement I will deal with it but I thought I would ask since, if it gave me pause, it might be holding other people back from donating as well.

    Thank you again,

    A patiently hopeful sufferer

    • Hi Staying Upbeat,

      Thank you both for the donation, and for pointing out this obvious oversight on my part. Yes, a donation to “The Halford Fund” will make its way to my lab via the Southern Illinois University Foundation. I will look into updating the other website, as you are right that having the word “Herpes” appear on proof of a tax-deductible donation is a hurdle that many people may not want to deal with. Thanks for bringing this to my attention.

      – Bill H.

  6. Great info! I look forward to all your ideas Bill. I hope we can get the FDA on board and break this stalemate!

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