Purpose of the Herpes Vaccine Blog

Bill Halford

WHO AM I?

My name is Bill Halford and I am an Associate Professor of Microbiology and Immunology at Southern Illinois University School of Medicine in Springfield, Illinois.  I have studied herpes simplex virus (HSV) biology since 1991, and I became interested in trying to develop a safe and effective HSV-2 vaccine in 2006.  There are at least 100 individuals in the world who are actively pursuing a HSV-2 vaccine, and I am one of these many researchers.  In this blog, I will try to cut through the nomenclature and statistics and explain in relatively straightforward terms what we know about HSV-2 vaccines and what we need to do next to advance a safe and effective HSV-2 vaccine to human clinical trials.  If you wish to contact me, you can do so via this blog or e-mail me at “[email protected]

 

DISCLAIMER

The author of this website, Bill Halford, is an employee of the Southern Illinois University School of Medicine in Springfield, Illinois.  The viewpoints expressed on this website are solely that of the author, and should not be construed as an official statement of the policies, procedures, or opinions of Southern Illinois University, the School of Medicine, or any of the academic departments contained therein.

 

BACKGROUND ON HSV-2 INFECTIONS AND GENITAL HERPES

Genital herpes caused by herpes simplex virus type 2 (HSV-2) remains a huge medical and public health problem.  About 1 billion people (out of ~7 billion total) are life-long carriers of the HSV-2 virus.  About 40 million of those HSV-2 infected persons live with genital herpes outbreaks that recur once every 2 to 12 months over the duration of their lives.  Each outbreak can last from 2 to 20 days in duration, and is physically uncomfortable and emotionally distressing.  Antiviral drugs such as acyclovir or valacyclovir (valtrex) reduce, but do not prevent. the symptoms of recurrent genital herpes.  Likewise, antiviral drugs have not slowed the spread of HSV-2 infection at all; ~20 million per year continue to acquire new HSV-2 infections from the 1 billion people who already carry the HSV-2 virus.

HSV-2 genital herpes has been described as a silent epidemic.  This term is apt, as HSV-2 exists all around us and is carried by friends and family members, but people are reluctant to disclose that they are infected with HSV-2 as there remains a historical stigma associated with this infection.  Many people who have the HSV-2 virus have not had many sexual partners, and many teenagers who acquire HSV-2 have the misfortune of acquiring HSV-2 with their first sexual partner.  Nonetheless, the social stigma that people with HSV-2 wish to avoid is the perception that they have slept with dozens of people.  For this and a variety of other reasons, the ~200 million people who have experienced symptoms of HSV-2 genital herpes do not tend to share this information with many people.  Thus, it is hard to estimate the magnitude of the problems caused by HSV-2 genital herpes.  One number helps put the problem into perspective; each of our children has a 1-in-10 chance of contracting a HSV-2 infection before they are married.

Aside from the individual suffering caused by recurrent genital herpes, HSV-2 infections can cause more severe complications such as HSV-2 infections of newborns as they pass through the vagina / birth canal.  The immune system of neonates is not yet developed, and thus HSV-2 infections in newborn babies can be devastating often resulting in death or severe mental / cognitive impairment, as HSV-2 infection can spread to the central nervous system of newborns.

 

THE POTENTIAL UTILITY OF A HSV-2 VACCINE

Effective vaccines have been responsible for the eradication and/or control of many viral diseases such as smallpox, yellow fever, red measles, mumps, German Measles, hepatitis B, chickenpox, and poliomyelitis.  In principle, there is no reason that a safe and effective HSV-2 vaccine could not be deployed in the human population to prevent HSV-2 genital herpes.

The applications of a safe and effective genital herpes vaccine would be two-fold.

First, an effective HSV-2 vaccine could be given to adolescents or prospective sexual partners of those who already carry the HSV-2 virus.  Exposure to an effective HSV-2 vaccine would bolster the immune system of such individuals such that their bodies were at least 100 times better prepared to repel the real (wild-type) HSV-2 pathogen if they were exposed later in life.  Such a “preventative HSV-2 vaccine” could be used to prevent ~20 million per year from newly acquiring the HSV-2 virus.

Second, an effective HSV-2 vaccine could be given to those who suffer from frequent outbreaks of recurrent genital herpes.  Such a “therapeutic HSV-2 vaccine” could be used to reduce the frequency and duration of genital herpes outbreaks in those ~40 million people worldwide who suffer from this chronic viral disease.  This latter application of a HSV-2 vaccine (i.e., to reduce symptoms in those who already carry the HSV-2 virus) would be more experimental, and less of a sure thing than a preventative HSV-2 vaccine.  Nonetheless, there are several publications dating back to the 1950s that claim such an effect has been obtained by treatment with a variety of vaccine formulations including inactivated-preparations of HSV virion particles.  Therefore, once a safe and effective HSV-2 preventative vaccine is identified, it will be relevant to determine if it has potential  to also serve as a therapeutic HSV-2 vaccine.

 

WHY DO WE STILL LACK AN EFFECTIVE HSV-2 VACCINE?

This is the million dollar question, and will be precisely the focus of the Herpes Vaccine Blog.

I envision posts on the Herpes Vaccine Blog serving one of three general purposes, and these will be discussions of:

1.  The science of HSV-2 vaccines

2.  Moving a safe and effective HSV-2 vaccine into human trials

3.  Answers to specific reader queries (which may be sent to [email protected])

 

What I hope to make clear through the development of this blog is that a safe and effective HSV-2 vaccine lies within our grasp, but what we lack is a critical mass of support to advance such a HSV-2 vaccine to human clinical trials.  The primary barriers to the advancement of an effective HSV-2 vaccine are (1) misinformation and (2) a pre-conceived notion that certain types of HSV-2 vaccines (e.g., live-attenuated) should not be investigated or considered for use as a human vaccine.

One of the central purposes of this blog will be to (try to) simply explain why past HSV-2 vaccines have not worked, and define what we need to do differently in the future if we intend to end the needless suffering caused by genital herpes.  Make no mistake…..HSV-2 genital herpes is a vaccine-preventable disease.  However, the field of HSV-2 vaccine research is long overdue for a “course correction.”  I hope that this blog serves as a vehicle to increase the public’s understanding of what we need to be doing differently if we hope to make HSV-2 genital herpes a disease of the past.

– Bill Halford

 



76 COMMENTS

  1. Hello Dr. Halford, I respect you so much! You seem to be a very caring person, and can tell you are a very humble and down to earth person. I wish nothing but good for you and your family. I praise the type of person you are. Dr. Halford, I was just wondering, if you have considered performing trials in Mexico or any other country you would be comfortable with? In Mexico you wouldn’t be under FDA scrutiny; from what I understand. You can set up lab there at a rather inexpensive cost versus here in the US. To give you an idea, if you were to raise $100,000 for a lab in Mexico it would equal to having $1,000,000 in the US. Believe me people who suffer from this terrible disease will make the trip down to Mexico for a potential cure!! You can hire Mexican labor such as big corporations do; in order to save cost. I know it may sound far fetched and unrealistic but so are the FDAs demands and ignorance. I believe you can do it. I would even give you a helping hand; I have a medical background and speak the language. Not all parts of Mexico are a nightmare. IDK, if a phase 1 trial were to be performed there sometime next year, it would mean so much for so many. Maybe during your Summer break or something. Thank you once again, for all your information and for all you do. You are heaven sent.

  2. I’ll be ur Guinea pig lol I read about how successful your vaccine is in animals online..next step humans..anything is better then living with this! I feel like lack of funding is stopping the cure/vaccine, that and big companies/pharmaceuticals do not want to loose out on all the money they are making from the suppressant drugs. I want to thank you for your hard work in finding a cure/vaccination for this virus.
    I also read this :
    http://www.researchgate.net/publication/236963380_Efficacy_of_the_anti-VZV_(anti-HSV3)_vaccine_in_HSV1_and_HSV2_recurrent_herpes_simplex_disease

    Taking the anti-varicella zoster virus (anti-VZV, also known as anti-HSV3) vaccine (ckn pox vaccine) against orobuccal herpes simplex virus type 1 (HSV1) and genital herpes simplex virus type 2 (HSV2). Does not cure the virus but stops outbreaks.
    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 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 non vaccinated herpes patients.
    Seems promising …since its a live strain as well….what do you think….lack of funding has stopped this study too….I just really wish for a cure/vaccine for the stopping of outbreaks(they r horrible)..and not having to worry about the life long expensive cost of med (which I am glad I have at least something to lean on ) .
    http://en.wikipedia.org/wiki/Herpes_simplex_research
    Thank you for your hard work and dedication to fighting this horrible virus.
    Amanda :)

    ABSTRACT 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 nonvac- cinated 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.

    • I also have had success w the VZV vaccine for my HSV1 outbreaks.
      After my 1st vaccination I was free of outbreaks for 4 years.
      I was revaccinated over a year ago and have had only 2 outbreaks so far.
      Incidentally, my outbreaks are quite severe, with ocular involvement.
      Dr Halford has been very helpful in sharing his learnings w lay people like myself.
      I have found most family doctors are not that informed re HSV1, so Bill’s advice has been invaluable.
      Bill, thank you so much! And here’s wishing everyone w HSV that Dr Halford continues to work on getting approval for his research!

  3. Hi Dr. Halford,
    I suffer from HSV2. The stigma from society and the emotional as well as physical damage it has done to me is a hard thing to deal with. I am currently taking a human pathophysiology class and we are discussing vaccines. From the readings and discussions, it seems to me that a live attenuated virus is the best option for preventing infections. Can you tell me why the government does not support you on your vaccine, even though you have had great success in animal trails? I know the likelihood of causing a herpes infection from a live attenuated virus vaccine is extremely minimal and would do a lot more good that bad (as seen with the polio live attenuated virus vaccine). If I had a ton of money I would donate it to you so you could move this vaccine to human clinical trials. I could be wrong, but I feel like the pharmaceutical companies don’t want a preventative vaccine for herpes because it would be a one time shot, versus having only therapeutic vaccines would mean continuous booster shots for those infected. Everything seems to boil down to money. Maybe if greed wasn’t so common these days, I would have already had a preventative vaccine for this before I became infected a couple of years ago (but that is just my opinion).

    • Dear E,

      You essentially asked “Why so much pushback regarding a live-attenuated HSV-2 vaccine when it is the most logical solution, and in fact may be the only approach that is likely to stop the spread of HSV-2 genital herpes in the human population?”

      After asking the question, you postulate / ask that perhaps greed is the underlying motivation based on the conspiracy theory idea that drug companies like having a population of tens of millions of people who could potentially take valtrex every day. The staggering number of people who have active genital herpes disease accounts for why valtrex alone is a $1.2 billion per year drug.

      The greed hypothesis assumes that the scientific community (as a whole) has their act together enough to (1) agree upon the most logical path forward to prevent HSV-2 genital herpes with a vaccine, but (2) is actively suppressing the deployment of this vaccine technology. Let me reassure you that this is NOT TRUE, and is not the root cause of why we continue to lack a HSV-2 vaccine.

      Although greed is a powerful potential incentive, the real explanation is far more banal and boring and is the same root cause of most of the USA’s problems…….the powerful double-whammy combination of (1) profound ignorance and (2) intellectual arrogance amongst our so-called leaders. Every person has blind spots in their existing knowledge database, and so do effective leaders. However, effective leaders (in a democratic society) are not afraid to admit where the boundaries of their understanding lie, and hence they LISTEN when people who are better informed on a specific, small topic approach with a logical and cohesive argument that suggests, perhaps, a change in policy or approach may be warranted. However, most of the FDA / NIH leadership seems to run on CYA-based decisions, rather than logic-based decisions, which dictate that it is effectively better to maintain the status quo of HSV-2 vaccine research (unlikely to succeed, but will not ruffle anyone’s feathers) rather than risk backing a new live-attenuated HSV-2 vaccine (more likely to succeed, but fraught with political danger and blow-back from the FDA).

      For the past 35 years, the leadership of the FDA, NIH, and Department of Health and Human Services has adamantly maintained that a “live-attenuated HSV-2 vaccine would be too dangerous to investigate or deploy in the human population,” and so we have opted for so-called “safer” HSV-2 subunit vaccines like Herpevac that have failed in six human clinical trials spanning the past 25 years. Genocea’s GEN-003 and Agenus’s HerpV vaccine appear to be on track for similar costly and time-consuming (time-wasting) failures. In my estimation, the leadership of the FDA and the NIH has little interest in reconsidering the wisdom of a 35-year-old policy to deliberately avoid research / investigation that could lead to the development of a live-attenuated HSV-2 vaccines. In part, this reflects a failure to consider the FACT that live-attenuated HSV-2 vaccines can be produced that are very safe. The other part of the equation boils down to intellectual arrogance, and reticence amongst the FDA and NIH to take ownership of the consequences of a HSV-2 vaccine subunit development “strategy” that has been consistently failing